Diagnostics

From PCR, FISH, IHC technologies to now the expanding applications of next-generation sequencing (NGS), biomarker targeted therapies are improving clinical outcomes. Furthermore, applications of circulating tumor DNA (ctDNA) testing have provided options for less invasive procedures while also providing more accurate and precise evaluation of tumor heterogeneity.

VERI tracks 600+ oncology diagnostic tests across global jurisdictions and across all oncology indications. Pulling news and data from recent regulatory approvals, social media, trial data releases, conference abstracts and other research publications, VERI can keep you up to date on both the diagnostic market landscape and the latest applications of new diagnostic tests in oncology.

Diagnostics


13 High-risk HPV Real-time PCR Kit (HBRT-H13C)	Cervical Cancer	Hybribio	CE-IVD (Old IVDD)
14 High-risk HPV with 16/18 Genotyping Real-time PCR Kit (HBRT-H14)	Cervical Cancer	Hybribio	CE Marked
23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)	Breast Cancer Male Breast Cancer Melanoma ...	23andMe	FDA Cleared (510k)
23andMe PGS Genetic Health Risk Report for MUTYH-Associated Polyposis (MAP)	Colorectal Cancer	23andMe	FDA Cleared (510k)
4D Lifetest™ Lung Dx	Lung Cancer	4D Lifetec	CE-IVD (Old IVDD)
ACTOnco	Breast Cancer Colon Cancer Endometrial Cancer ...	Prenetics	FDA Cleared (510k)
ADPS™ EGFR Mutation Test Kit	Non Small Cell Lung Cancer	Genecast	CE-IVD (Old IVDD)
ADXBLADDER	Bladder Cancer	Arquer Diagnostics	CE-IVD (Old IVDD)
ADXGYNAE	Endometrial Cancer	Arquer Diagnostics	Research Use Only
ALINITY m HR HPV ASSAY	Cervical Cancer	Abbott	FDA Approved (PMA)
AMBLor®	Melanoma	AMLo Biosciences	Other Approval
AML Express™	Acute Myelogenous Leukemia	NeoGenomics	Laboratory Developed Test
AML1/ETO (RUNX1/RUNX1T1) Translocation, Dual Fusion FISH Probe Kit	Acute Myelogenous Leukemia	Sysmex Corp	FDA Authorized (EUA/De Novo)
APIS Breast Cancer Subtyping Kit	Breast Cancer	APIS Assay Techno	Laboratory Developed Test
APIS ESR1 Mutations Kit	Breast Cancer	APIS Assay Techno	Research Use Only
ASPYRE-Lung	Lung Cancer	Biofidelity	Laboratory Developed Test
ATRX Rabbit Polyclonal Antibody	Brain Cancer	Roche	Laboratory Developed Test
AVENIO Tumor Tissue CGP Kit	Solid Tumor	Roche	Laboratory Developed Test
AVENIO Tumor Tissue Expanded Kit	Solid Tumor	Roche	Research Use Only
AVENIO Tumor Tissue Surveillance Kit	Colorectal Cancer	Roche	Research Use Only
AVENIO Tumor Tissue Targeted Kit	Solid Tumor	Roche	Research Use Only
AVENIO ctDNA Expanded Kit	Colorectal Cancer Lung Cancer	Roche	Research Use Only
AVENIO ctDNA Surveillance Kit	Colorectal Cancer Lung Cancer	Roche	Research Use Only
AVENIO ctDNA Targeted Kit	Colorectal Cancer Lung Cancer	Roche	Research Use Only
AYVAKIT® CDx test	Gastrointestinal Stromal Tumor	Genetron Health	Other Approval
Abbott RealTime HR HPV assay	Cervical Cancer	Abbott	CE Marked
Abbott RealTime IDH1	Acute Myelogenous Leukemia Myelodysplastic Syndrome	Abbott	FDA Approved (PMA)
Abbott RealTime IDH2	Acute Myelogenous Leukemia	Abbott	FDA Approved (PMA)
Afirma® Genomic Sequencing Classifier	Thyroid Gland Medullary Carcinoma	Veracyte	Laboratory Developed Test
Agilent SureSelect Cancer CGP Assay	Solid Tumor	Agilent Tech	Research Use Only
AidaBreast™	Breast Cancer	PreludeDx	Laboratory Developed Test
AlphaLiquid HRR ctDNA test	Breast Cancer Ovarian Cancer Prostate Cancer	IMBdx	Laboratory Developed Test
AlphaLiquid® 100	Breast Cancer Colon Cancer Gastric Cancer ...	IMBdx	CE Marked
AlphaLiquid® Detect	Colorectal Cancer Solid Tumor	IMBdx	Laboratory Developed Test
Altera		Natera	Laboratory Developed Test
AmoyDx EGFR 29 Mutations Detection Kit	Non Small Cell Lung Cancer	Amoy Diagnostics	CE Marked
AmoyDx MET Mutation Detection Kit	Non Small Cell Lung Cancer	Amoy Diagnostics	Research Use Only
AmoyDx Super-ARMS® EGFR Mutation Detection Kit	Non Small Cell Lung Cancer	Amoy Diagnostics	CE-IVD (Old IVDD)
AmoyDx® BRAF V600 Mutations Detection Kit	Colorectal Cancer Melanoma Ovarian Cancer ...	Amoy Diagnostics	CE-IVD (Old IVDD)
AmoyDx® BRCA Pro Panel	Breast Cancer Ovarian Cancer Pancreatic Cancer ...	Amoy Diagnostics	Laboratory Developed Test
AmoyDx® BRCA1 and BRCA2 Gene Mutation Detection Kit	Breast Cancer Ovarian Cancer	Amoy Diagnostics	Other Approval
AmoyDx® C-KIT Mutation Detection Kit	Acute Myelogenous Leukemia Gastrointestinal Stromal Tumor Testicular Cancer	Amoy Diagnostics	Research Use Only
AmoyDx® EML4-ALK Fusion Gene Detection Kit	Non Small Cell Lung Cancer	Amoy Diagnostics	Research Use Only
AmoyDx® Essential NGS Panel	Colorectal Cancer Non Small Cell Lung Cancer	Amoy Diagnostics	CE-IVD (Old IVDD)
AmoyDx® FGFR2 Break-apart FISH Probe Kit		Amoy Diagnostics	Other Approval
AmoyDx® HANDLE Classic NGS Panel	Solid Tumor	Amoy Diagnostics	CE-IVD (Old IVDD)
AmoyDx® HANDLE HRR NGS Panel		Amoy Diagnostics	CE-IVD (Old IVDD)
AmoyDx® HER2 Mutation Detection Kit		Amoy Diagnostics	Research Use Only
AmoyDx® HRD Complete Panel	Breast Cancer Ovarian Cancer Prostate Cancer	Amoy Diagnostics	Research Use Only
AmoyDx® HRD Focus Panel	Ovarian Cancer	Amoy Diagnostics	CE-IVD (Old IVDD)
AmoyDx® Human Papillomavirus (HPV) Genotyping Detection Kit	Cervical Cancer	Amoy Diagnostics	CE-IVD (Old IVDD)
AmoyDx® JAK2 Mutation Detection Kit	Lung Cancer	Amoy Diagnostics	Research Use Only
AmoyDx® KRAS Mutation Detection Kit	Colorectal Cancer	Amoy Diagnostics	CE-IVD (Old IVDD)
AmoyDx® KRAS/NRAS Mutations Detection Kit	Colorectal Cancer	Amoy Diagnostics	CE-IVD (Old IVDD)
AmoyDx® MSI detection kit	Solid Tumor	Amoy Diagnostics	Research Use Only
AmoyDx® Master Panel	Non Small Cell Lung Cancer	Amoy Diagnostics	Research Use Only
AmoyDx® NTRK Gene Fusions Detection Kit	Solid Tumor	Amoy Diagnostics	CE-IVD (Old IVDD)
AmoyDx® PD-L1 Expression Detection Kit	Non Small Cell Lung Cancer	Amoy Diagnostics	Other Approval
AmoyDx® PIK3CA Five Mutations Detection Kit	Solid Tumor	Amoy Diagnostics	CE-IVD (Old IVDD)
AmoyDx® PIK3CA mutation detection kit	Solid Tumor	Amoy Diagnostics	CE-IVD (Old IVDD)
AmoyDx® Pan Lung Cancer PCR Panel	Non Small Cell Lung Cancer	Amoy Diagnostics	Other Approval
AmoyDx® ROS1 Gene Fusions Detection Kit	Non Small Cell Lung Cancer	Amoy Diagnostics	CE-IVD (Old IVDD)
AmoyDx®HER-2 Gene Amplification Analysis Kit	Gastric Cancer Ovarian Cancer Prostate Cancer	Amoy Diagnostics	CE Marked
AmpFire HPV Assay	Cervical Cancer	Atila Biosystems	CE-IVD (Old IVDD)
AmpliMark™	Lung Cancer Urothelial Cancer	Lucence	Laboratory Developed Test
AmplideX® Nanopore Carrier Plus Kit		Bio-Techne	Research Use Only
AnchorAIM® 10 Gene Test for Individualized Treatment of Lung Cancer	Lung Cancer Non Small Cell Lung Cancer	AnchorDx	Laboratory Developed Test
AnchorAIM® 72 gene detection for individualized treatment of solid tumors	Solid Tumor	AnchorDx	Laboratory Developed Test
AnchorAIM® Personalized Treatment of Colorectal Cancer 11 Gene Test	Colorectal Cancer	AnchorDx	Laboratory Developed Test
AnchorIRIS™		AnchorDx	Laboratory Developed Test
Anti-PRAME (EPR 20330) Rabbit Monoclonal Primary Antibody		Roche	CE-IVD (Old IVDD)
ArcherMET	Non Small Cell Lung Cancer	Invitae Corp	Other Approval
Archer® FusionPlex® Acute Lymphoblastic Leukemia (ALL)	Acute Lymphocytic Leukemia	Integrated DNA Technologies	Laboratory Developed Test
Archer® FusionPlex® Comprehensive Thyroid & Lung (CTL) Kit	Lung Cancer Thyroid Gland Carcinoma	Integrated DNA Technologies	Laboratory Developed Test
Archer® FusionPlex® Lung Kit	Lung Cancer	Integrated DNA Technologies	Research Use Only
Archer® FusionPlex® Lymphoma	Lymphoma	Integrated DNA Technologies	Laboratory Developed Test
Archer® FusionPlex® Myeloid Kit	Acute Lymphocytic Leukemia Chronic Myeloid Leukemia Myelodysplastic Syndrome	Integrated DNA Technologies	Laboratory Developed Test
Archer® FusionPlex® Oncology Research Kit	Solid Tumor	Integrated DNA Technologies	Laboratory Developed Test
Archer® FusionPlex® Sarcoma kit	Sarcoma	Integrated DNA Technologies	Laboratory Developed Test
Archer® VariantPlex® Comprehensive Thyroid and Lung (CTL) kit	Lung Cancer Thyroid Gland Carcinoma	Integrated DNA Technologies	Laboratory Developed Test
Archer® VariantPlex® Myeloid panel	Chronic Myeloid Leukemia	Integrated DNA Technologies	Laboratory Developed Test
Archer® VariantPlex® Solid Tumor Kit	Breast Cancer Colorectal Cancer Melanoma	Integrated DNA Technologies	Laboratory Developed Test
Archer™ FusionPlex™ Core Solid Tumor Panel	Breast Cancer Colorectal Cancer Gastric Cancer ...	Integrated DNA Technologies	Laboratory Developed Test
Archer™ VARIANTPlex™ Complete Solid Tumor panel	Breast Cancer CNS Tumor Colorectal Cancer ...	Integrated DNA Technologies	Laboratory Developed Test
Archer™ VARIANTPlex™ HRD Module	Solid Tumor	Integrated DNA Technologies	Laboratory Developed Test
Archer™ VARIANTPlex™ Lymphoma panel	Lymphoma	Integrated DNA Technologies	Laboratory Developed Test
Archer™ VARIANTPlex™ Pan Solid Tumor panel	Breast Cancer CNS Tumor Colorectal Cancer ...	Integrated DNA Technologies	Laboratory Developed Test
Aristotle®	Bladder Cancer Breast Cancer Cervical Cancer ...	StageZero Life Sci	Laboratory Developed Test
ArteraAI Prostate Test	Prostate Cancer	ArteraAI	Laboratory Developed Test
Aspyre® Lung	Lung Cancer	Biofidelity	Laboratory Developed Test
AssureMDx	Bladder Cancer	Vesica Health	Laboratory Developed Test
Avantect™	Pancreatic Cancer	ClearNote Health	Laboratory Developed Test
Aventa FusionPlus Test	Solid Tumor	Aventa Genomics	Laboratory Developed Test
BCDx Monitoring Test	Bladder Cancer	Early Is Good	Laboratory Developed Test
BD Onclarity™ HPV Assay	Cervical Cancer	BD Biosci	FDA Approved (PMA)
BE-Smart Esophageal Pre-Cancer screening test	Esophageal Cancer	ProPhase	Laboratory Developed Test
BOND MMR Antibody Panel	Colorectal Cancer	Danaher Corp	FDA Cleared (510k)
BRACAnalysis CDx™	Breast Cancer Ovarian Cancer Pancreatic Cancer ...	Myriad Genetics	FDA Approved (PMA)
BRCA MASTR Plus Dx	Breast Cancer Ovarian Cancer	Agilent Tech	CE Marked
BRCANext®	Breast Cancer Gynecologic Cancers Male Breast Cancer ...	Konica Minolta	Laboratory Developed Test
BRCAaccuTest PLUS	Breast Cancer Ovarian Cancer	NGeneBio	CE-IVD (Old IVDD)
BRCAplus®	Breast Cancer Ovarian Cancer	Konica Minolta	Laboratory Developed Test
BRCAvantage™ Plus	Breast Cancer Ovarian Cancer	Quest Diagnostics	Laboratory Developed Test
BROCA Cancer Risk Panel	Breast Cancer Colorectal Cancer Endocrine Cancer ...	University of Washington	Laboratory Developed Test
BT-Reveal™ Early Pancreatic Cancer Test	Pancreatic Cancer	Breakthrough Genomics	Laboratory Developed Test
BTA stat®	Bladder Cancer	Polymedco	FDA Cleared (510k)
Bladder EpiCheck®	Bladder Cancer	Nucleix	CE-IVD (Old IVDD)
Bloodhound™ MPN panel	Essential Thrombocythemia Hematological Malignancies Myelofibrosis ...	Precipio	Laboratory Developed Test
BluePrint	Breast Cancer	Agendia	CE Marked
Blueprint Genetics Comprehensive Hereditary Cancer Panel		Quest Diagnostics	Laboratory Developed Test
Bond Oracle HER2 IHC System	Breast Cancer	Danaher Corp	FDA Approved (PMA)
BostonGene Tumor Portrait™ Test	Bladder Cancer Melanoma Solid Tumor	BostonGene	Laboratory Developed Test
BrainTumorNext®	Brain Cancer Colorectal Cancer	Konica Minolta	Laboratory Developed Test
Breast Cancer Index®	Breast Cancer	Hologic	Laboratory Developed Test
BreastNext®	Breast Cancer Ovarian Cancer	Konica Minolta	Laboratory Developed Test
Brightplex® MDSC Assay	Non Small Cell Lung Cancer	Veracyte	Laboratory Developed Test
C2inform test	Bladder Cancer Colorectal Cancer Glioblastoma ...	Veracyte	CE-IVD (Old IVDD)
CBFβ (CBFB) /MYH11 Translocation, Dual Fusion FISH Probe Kit	Acute Myelogenous Leukemia	Sysmex Corp	FDA Authorized (EUA/De Novo)
CELLSEARCH®	Breast Cancer Colorectal Cancer Prostate Cancer ...	Menarini	FDA Cleared (510k)
CELsignia test	Breast Cancer	Celcuity	Laboratory Developed Test
CEP 12 SpectrumOrange DNA Probe	Chronic Lymphocytic Leukemia	Abbott	FDA Approved (PMA)
CINtec® PLUS Cytology	Cervical Cancer	Roche	FDA Approved (PMA)
CNSide™ Cerebrospinal Fluid Assay	Brain Cancer CNS Tumor Melanoma	Biocept	Laboratory Developed Test
CNV+ Breast Cancer NGS Panel	Breast Cancer	NuProbe	Laboratory Developed Test
COLARIS AP®	Colon Cancer	Myriad Genetics	Laboratory Developed Test
COLARIS®	Colorectal Cancer Endometrial Cancer	Myriad Genetics	Laboratory Developed Test
COLO eDX	Colorectal Cancer	Gencurix	Laboratory Developed Test
COLOTECT™ 1.0	Colorectal Cancer	BGI Group	CE Marked
COLVERA™	Colorectal Cancer	Clinical Genomics	Laboratory Developed Test
CONFIRM anti-Total c-MET (SP44) Rabbit Monoclonal Primary Antibody	Gastric Cancer Non Small Cell Lung Cancer	Roche	Laboratory Developed Test
CONFIRM anti-p53 (DO-7) Primary Antibody	Colon Cancer	Roche	Laboratory Developed Test
CRCdx® RAS Mutation Detection Kit	Colorectal Cancer	EntroGen	FDA Approved (PMA)
CanAssist Breast	Breast Cancer HER2 Negative Breast Cancer Hormone Receptor Positive Breast Cancer	OncoStem Diagnostics	Other Approval
CanScan™	Endometrial Cancer Esophageal Cancer Gastric Cancer ...	Geneseeq	CE Marked
CanSense-CRC® blood test	Small Bowel Adenocarcinoma	CanSense	Laboratory Developed Test
CancerDetect™	Oral Cancer	Viome	Laboratory Developed Test
CancerNext ®	Breast Cancer Colorectal Cancer Melanoma ...	Konica Minolta	Laboratory Developed Test
CancerNext-Expanded®	Breast Cancer Colon Cancer Ovarian Cancer ...	Konica Minolta	Laboratory Developed Test
CancerSCAN	Leukemia Lymphoma Non Small Cell Lung Cancer ...	Geninus	Laboratory Developed Test
CancerSEEK	Leukemia Lymphoma Solid Tumor	Exact Sciences Corp	Laboratory Developed Test
CancerTYPE ID®	Breast Cancer Colorectal Cancer Endometrial Cancer ...	Hologic	Laboratory Developed Test
CancerVision		Inocras	Laboratory Developed Test
Cancerguard™	Breast Cancer Cervical Cancer Colorectal Cancer ...	Exact Sciences Corp	Laboratory Developed Test
Cancertrack™		Datar Cancer Genetics	Laboratory Developed Test
Canhelp-Kidney® Assay	Renal Cell Carcinoma	Canhelp Genomics	Other Approval
Canhelp-Lung® Assay	Lung Adenocarcinoma Lung Cancer Lung Non-Small Cell Squamous Cancer	Canhelp Genomics	Other Approval
Canhelp-MB® Assay	Medulloblastoma	Canhelp Genomics	Other Approval
Canhelp-Origin® Assay	Triple Negative Breast Cancer	Canhelp Genomics	Other Approval
Canhelp-UriBLAD	Urothelial Cancer	Canhelp Genomics	CE Marked
Caris Assure™	Solid Tumor	Caris Life Sci	Laboratory Developed Test
CellMax-LBx Liquid Biopsy	Solid Tumor	CellMax Life	Laboratory Developed Test
CercaTest™ ERBB2 Assay	Breast Cancer	Shuwen Biotech	CE Marked
CervicaDx	Cervical Cancer	Predica Diagnostics	Laboratory Developed Test
ClarityDX Prostate®	Prostate Cancer	Nanostics	CE Marked
Claudin18.2 IHC 14G11 pharmDx	Gastric Cancer Gastroesophageal Junction Adenocarcinoma	Agilent Tech	Laboratory Developed Test
ClearSEEK™ PIK3CA Panel	Breast Cancer	Agena Bio	Laboratory Developed Test
ColoAlert	Colorectal Cancer	Mainz BioMed
ColoClear	Colorectal Cancer	Prenetics	Other Approval
ColoNext®	Colon Cancer Colorectal Cancer	Tempus	Laboratory Developed Test
ColoNode®	Colorectal Cancer	HiloProbe	CE-IVD (Old IVDD)
ColoSTAT®	Colorectal Cancer	Vision Tech Bio	CE Marked
ColoScape™ Colorectal Cancer Mutation Detection Test	Colorectal Cancer	DiaCarta	CE-IVD (Old IVDD)
ColoSense™	Colorectal Cancer	Geneoscopy	FDA Approved (PMA)
ColoSeq™	Colon Cancer Endometrial Cancer	University of Washington	Laboratory Developed Test
Colodiag®	Colorectal Cancer	OncoDiag	Laboratory Developed Test
Cologuard Plus™	Colorectal Cancer	Exact Sciences Corp	FDA Approved (PMA)
Cologuard®	Colorectal Cancer	Exact Sciences Corp	FDA Approved (PMA)
ColonAiQ Multi-Gene Methylation Detection Test	Colorectal Cancer	Singlera Genomics	Laboratory Developed Test
ConfirmMDx	Prostate Cancer	MDxHealth	Laboratory Developed Test
Counsyl Reliant™ Cancer Screen	Breast Cancer Colon Cancer Ovarian Cancer ...	Myriad Genetics	Other Approval
Curebest™ 95GC Breast	Breast Cancer	Sysmex Corp	Laboratory Developed Test
CustomNext-Cancer®		Tempus	Laboratory Developed Test
Cxbladder	Bladder Cancer	Pacific Edge	Laboratory Developed Test
CyPath® Lung	Lung Cancer	bioAffinity Technologies	Laboratory Developed Test
DCISionRT	Breast Cancer	PreludeDx	Laboratory Developed Test
DEEPGEN™ Panel	Bladder Cancer Breast Cancer Cervical Cancer ...	Quantgene	Laboratory Developed Test
DEL(5Q)Deletion Fish Probe Kit	Acute Myelogenous Leukemia Myelodysplastic Syndrome	Sysmex Corp	FDA Authorized (EUA/De Novo)
DELFI-Tumor Fraction assay		Delfi Diagnostics	Laboratory Developed Test
DLBCL-COO Assay	Diffuse Large B Cell Lymphoma	Canhelp Genomics	Laboratory Developed Test
DNA Methylation Detection Kit for Human SDC2, ADHFE1, and PPP2R5C	Colorectal Cancer	BGI Group	CE-IVD (Old IVDD)
DNADX®	Breast Cancer	Reveal Genomics	Research Use Only
DRP®-5FU	Colorectal Cancer	Allarity Therap	Laboratory Developed Test
DRP®-Dovitinib	Breast Cancer Renal Cell Carcinoma	Allarity Therap	Laboratory Developed Test
DRP®-Ixempra	Breast Cancer	Allarity Therap	Laboratory Developed Test
DRP®-Stenoparib CDx	Ovarian Cancer	Allarity Therap	Laboratory Developed Test
Dako EGFR pharmDx™	Colorectal Cancer	Agilent Tech	FDA Approved (PMA)
Dako c-KIT pharmDx	Colorectal Cancer Gastrointestinal Stromal Tumor	Agilent Tech	FDA Approved (PMA)
Dawn™	Lung Cancer Melanoma Pancreatic Cancer	Intervenn Biosci	Laboratory Developed Test
Decipher Bladder Test	Bladder Cancer	Veracyte	Laboratory Developed Test
Decipher Prostate Cancer Test	Prostate Cancer	Veracyte	Laboratory Developed Test
DecisionDx® DiffDx-Melanoma	Melanoma	Castle Biosci	Laboratory Developed Test
DecisionDx®-CMSeq	Cutaneous Melanoma	Castle Biosci	Laboratory Developed Test
DecisionDx®-Melanoma	Cutaneous Melanoma	Castle Biosci	Laboratory Developed Test
DecisionDx®-PRAME	Uveal Melanoma	Castle Biosci	Laboratory Developed Test
DecisionDx®-SCC	Squamous Cell Carcinoma	Castle Biosci	Laboratory Developed Test
DecisionDx®-UM	Uveal Melanoma	Castle Biosci	Laboratory Developed Test
DecisionDx®-UMSeq	Uveal Melanoma	Castle Biosci	Laboratory Developed Test
DefineMBC™	Breast Cancer	Epic Sciences	Laboratory Developed Test
Del(20Q) deletion fish probe Kit	Myelodysplastic Syndrome	Sysmex Corp	FDA Authorized (EUA/De Novo)
Del(7q) Deletion FISH Probe Kit	Acute Myelogenous Leukemia Myelodysplastic Syndrome	Sysmex Corp	FDA Approved (PMA)
DermTech Melanoma Test	Melanoma	DermTech	Laboratory Developed Test
DetermaCNI™	Lung Cancer	Oncocyte	Laboratory Developed Test
DetermaIO™	Non Small Cell Lung Cancer	Oncocyte	Laboratory Developed Test
DetermaMx™		Oncocyte	Laboratory Developed Test
DetermaRx™	Lung Adenocarcinoma Lung Non-Squamous Non-Small Cell Cancer Non Small Cell Lung Cancer	Oncocyte	Laboratory Developed Test
DetermaTx™	Solid Tumor	Oncocyte	Laboratory Developed Test
Devyser BRCA NGS	Breast Cancer Ovarian Cancer	Devyser	CE-IVD (Old IVDD)
Devyser BRCA PALB2 NGS	Breast Cancer Ovarian Serous Adenocarcinoma	Devyser	Laboratory Developed Test
Devyser CFTR NGS assay	Cystic Fibrosis	Devyser	Laboratory Developed Test
Devyser HBOC NGS	Breast Cancer Ovarian Cancer	Devyser	CE-IVD (Old IVDD)
Devyser LynchFAP		Devyser	Laboratory Developed Test
DiviTum® TKa test	Hormone Receptor Positive Breast Cancer	Biovica	Laboratory Developed Test
Droplex BRAF Mutation Test	Colorectal Cancer Melanoma Thyroid Gland Papillary Carcinoma	Gencurix	CE-IVD (Old IVDD)
Droplex EGFR Mutation Test v2	Non Small Cell Lung Cancer	Gencurix	CE-IVD (Old IVDD)
Droplex KRAS Mutation Test	Colorectal Cancer Non Small Cell Lung Cancer Pancreatic Cancer	Gencurix	CE Marked
Droplex PIK3CA Mutation Test	Breast Cancer Non Small Cell Lung Cancer	Gencurix	CE-IVD (Old IVDD)
Droplex POLE Mutation Test	Endometrial Cancer	Gencurix	CE Marked
Droplex c-Met Exon14 Skipping Test	Non Small Cell Lung Cancer	Gencurix	CE-IVD (Old IVDD)
DxFLEX cytometer	Leukemia Lymphoma	Danaher Corp	CE Marked
Dxcover PANAROMIC Platform	Solid Tumor	Dxcover	Laboratory Developed Test
EGFR/KRAS/ALK Gene Mutation Detection Kit	Non Small Cell Lung Cancer	BGI Group	Other Approval
ER/PR pharmDx™ Kit	Breast Cancer	Agilent Tech	FDA Approved (PMA)
EVI1 (MECOM) Breakapart Fish Probe Kit	Acute Myelogenous Leukemia Myelodysplastic Syndrome	Sysmex Corp	FDA Authorized (EUA/De Novo)
EXpressCT Liquid Biopsy Test		Genecentric	Laboratory Developed Test
Early-stage NSCLC Panel	Non Small Cell Lung Cancer	NeoGenomics	Laboratory Developed Test
EarlyCDT®-Lung	Lung Cancer	Freenome	CE Marked
EasyM™ assay	Multiple Myeloma	Rapid Novor	Laboratory Developed Test
EasyPGX® Ready KRAS	Cholangiocarcinoma Colorectal Cancer Non Small Cell Lung Cancer ...	Diatech Pharmacogenetics	CE-IVDR (New IVDR)
EasyPGX® ready MSI		Diatech Pharmacogenetics	CE-IVD (Old IVDD)
Elecsys Anti-p53 Immunoassay	Breast Cancer Colorectal Cancer Head and Neck Cancer	Roche	CE Marked
Empower™ Hereditary cancer test		Natera	Laboratory Developed Test
EndoPredict®	Breast Cancer	Myriad Genetics	Laboratory Developed Test
Epi proColon®	Colorectal Cancer	Epigenomics
Epi proLung®	Lung Cancer	Epigenomics	CE Marked
Epi-TOP LUNG assay	Lung Cancer	Seasun Biomaterials	Laboratory Developed Test
Epi-TOP MPP Assay Panel		Seasun Biomaterials	Laboratory Developed Test
EpiCapture Test	Prostate Cancer	Trinity Biotech	Laboratory Developed Test
EpiLung assay	Lung Cancer	Epigenomics	Laboratory Developed Test
Esopredict™ test	Esophageal Cancer	Previse	Laboratory Developed Test
EuroFlow 8-color MM panel	Multiple Myeloma	Cytognos	CE-IVD (Old IVDD)
ExoDx™ Prostate (IntelliScore) Test	Prostate Cancer	Bio-Techne	CE-IVD (Old IVDD)
ExoLution™ Plus cfDNA + exoRNA Isolation Kit	Breast Cancer	Bio-Techne	Research Use Only
ExoVita™ Pancreas	Pancreatic Ductal Adenocarcinoma	Biological Dynamics	Laboratory Developed Test
FGFR-PRS test	Bladder Cancer Urothelial Cancer	Genecentric	Laboratory Developed Test
FITRapid	Colorectal Cancer Gastric Cancer	MiRXES	Other Approval
FLT3 ITD MRD Assay	Acute Myelogenous Leukemia	Invivoscribe Techno	Research Use Only
Find It®	Basal Cell Carcinoma Breast Cancer Colorectal Cancer ...	Canexia Health	Laboratory Developed Test
FirstLook Lung	Lung Cancer	Delfi Diagnostics	Laboratory Developed Test
FirstSight™ CRC Test	Colorectal Cancer	CellMax Life	Laboratory Developed Test
Follow It®	Solid Tumor	Canexia Health	Laboratory Developed Test
Foresight CLARITY™	Diffuse Large B Cell Lymphoma Follicular Lymphoma Hodgkin Lymphoma	Foresight Diagnostics	Laboratory Developed Test
Foresight Solid Tumor Recurrence Test	Solid Tumor	Foresight Diagnostics	Laboratory Developed Test
FoundationFocus CDxBRCA Assay	Ovarian Cancer	Roche
FoundationOne® CDx	Biliary Tract Cancer Breast Cancer Cholangiocarcinoma ...	Roche	FDA Approved (PMA)
FoundationOne® Germline		Roche	Laboratory Developed Test
FoundationOne® Germline More		Roche	Laboratory Developed Test
FoundationOne® Heme CDx	Hematological Malignancies Sarcoma Solid Tumor	Roche	Laboratory Developed Test
FoundationOne® Liquid CDx	Breast Cancer Colorectal Cancer Non Small Cell Lung Cancer ...	Roche	FDA Approved (PMA)
FoundationOne®Monitor		Roche	Laboratory Developed Test
FoundationOne®RNA	Gastrointestinal Cancer Non Small Cell Lung Cancer Sarcoma	Roche	Laboratory Developed Test
FoundationOne®Tracker	Solid Tumor	Roche	Laboratory Developed Test
FulgentExome		Fulgent Genetics	CE Marked
FusionPlex® Dx	Non Small Cell Lung Cancer Solid Tumor	Integrated DNA Technologies	CE-IVD (Old IVDD)
FusionPlex® Pan Solid Tumor v2 panel	Solid Tumor	Integrated DNA Technologies	Laboratory Developed Test
FusionPlex™ Heme v2 panel	Hematological Malignancies	Integrated DNA Technologies	Laboratory Developed Test
FusionPlex™ Pan-Heme panel	Lymphoma Myeloma	Integrated DNA Technologies	Laboratory Developed Test
FusionScan Plus		Genetron Health	CE Marked
GALEAS Tumor		Nonacus	Laboratory Developed Test
GALEAS® Bladder	Bladder Cancer	Nonacus	Laboratory Developed Test
GALEAS™ Hereditary Plus	Brain Cancer Breast Cancer Colon Cancer ...	Nonacus	Laboratory Developed Test
GALEAS™ Tumor	Solid Tumor	Nonacus	Laboratory Developed Test
GALEAS™ uPCR: ESR1	Breast Cancer	Nonacus	Research Use Only
GASTROClear Test	Gastric Cancer	MiRXES	CE Marked
GEUS-CLL	Chronic Lymphocytic Leukemia	Aniling	CE Marked
GEUS-CRC	Colorectal Cancer	Aniling	CE Marked
GEUS-LB	Colorectal Cancer	Aniling	CE Marked
GRAIL Non-Small Cell Lung Cancer (NSCLC) ctDNA Assay	Non Small Cell Lung Cancer	GRAIL	Laboratory Developed Test
GUARDANT SHIELD	Colorectal Cancer Lung Cancer	Guardant Health	FDA Approved (PMA)
GYNplus®	Breast Cancer Ovarian Cancer Thyroid Gland Carcinoma ...	Konica Minolta	Laboratory Developed Test
Galen™ Breast HER2	Breast Cancer	Ibex Medical Analytics	Research Use Only
Galen™ Gastric	Gastric Cancer	Ibex Medical Analytics	Research Use Only
Galen™ Prostate	Prostate Cancer	Ibex Medical Analytics	CE-IVD (Old IVDD)
Galleri Test	Adrenal Cortex Carcinoma Ampulla of Vater Carcinoma Anal Carcinoma ...	GRAIL	Laboratory Developed Test
GenMineTOP Cancer Genome Profiling System	Solid Tumor	Konica Minolta	Other Approval
GeneStrat® test	Non Small Cell Lung Cancer	Biodesix	Laboratory Developed Test
GenesWell BCT	Breast Cancer	Gencurix	Other Approval
GenesWell ddEGFR Mutation Test	Non Small Cell Lung Cancer	Gencurix	Other Approval
GeneseeqPrime™	Lung Cancer Solid Tumor	Geneseeq	CE Marked
GeneseeqPrime™HRD	Solid Tumor	Geneseeq	CE-IVD (Old IVDD)
Geneseeq’s NGS Liquid Biopsy Kit		Geneseeq	Other Approval
GenoPredicta™	Multiple Myeloma	Predicta Biosciences	Laboratory Developed Test
GenomicsNext™ Liquid Biopsy		Genecentric	Laboratory Developed Test
GlycoVision™	Colorectal Cancer Prostate Cancer	Intervenn Biosci	Laboratory Developed Test
Guardant360 Response™	Bladder Cancer Breast Cancer Gastric Cancer ...	Guardant Health	Laboratory Developed Test
Guardant360 TissueNext™	Non Small Cell Lung Cancer	Guardant Health	Laboratory Developed Test
Guardant360® CDx	Colorectal Cancer Gastric Cancer Non Small Cell Lung Cancer ...	Guardant Health
GuardantINFINITY™	Solid Tumor	Guardant Health	Research Use Only
GuardantOMNI	Colorectal Cancer Non Small Cell Lung Cancer	Guardant Health	Laboratory Developed Test
GuardantREVEAL	Colorectal Cancer	Guardant Health	Laboratory Developed Test
GutSeer assay	Solid Tumor	Singlera Genomics	CE-IVD (Old IVDD)
GynTect®	Cervical Cancer	Oncgnostics	CE-IVD (Old IVDD)
HCCBloodTest	Hepatocellular Cancer	Epigenomics	CE-IVD (Old IVDD)
HCCscreen™	Hepatocellular Cancer	Genetron Health	Laboratory Developed Test
HDPCR NSCLC RUO Assay	Non Small Cell Lung Cancer	ChromaCode	Laboratory Developed Test
HELICORapid	Colorectal Cancer Gastric Cancer	MiRXES	Other Approval
HEMEaccuTest™	Acute Lymphocytic Leukemia Acute Myelogenous Leukemia Lymphoma ...	NGeneBio	CE-IVD (Old IVDD)
HEPA eDX	Liver Cancer	Gencurix	Laboratory Developed Test
HER2 CISH pharmDx Kit	Breast Cancer	Agilent Tech	FDA Approved (PMA)
HER2 IQFISH pharmDx	Breast Cancer Gastric Cancer Gastroesophageal Cancer	Agilent Tech	FDA Approved (PMA)
HER2DX	Breast Cancer	Reveal Genomics	Laboratory Developed Test
HPV OncoTect 3Dx	Cervical Cancer	InCellDx	CE-IVD (Old IVDD)
HPV Selfy	Cervical Cancer	Ulisse BioMed	CE Marked
HTG EdgeSeq ALKPlus Assay EU	Non Small Cell Lung Cancer	HTG Molecular Diagnostics	CE Marked
HTG EdgeSeq DLBCL Cell of Origin Assay	Diffuse Large B Cell Lymphoma	HTG Molecular Diagnostics	Research Use Only
HTG EdgeSeq DLBCL Cell of Origin Assay EU	Diffuse Large B Cell Lymphoma	HTG Molecular Diagnostics	CE-IVD (Old IVDD)
HTG EdgeSeq Lung Fusions Assay	Non Small Cell Lung Cancer	HTG Molecular Diagnostics	Research Use Only
HTG EdgeSeq Oncology Biomarker Panel (OBP)	Breast Cancer Colorectal Cancer Lung Cancer ...	HTG Molecular Diagnostics	Research Use Only
HTG EdgeSeq Pan B-Cell Lymphoma Panel	Burkitt Lymphoma Chronic Lymphocytic Leukemia Diffuse Large B Cell Lymphoma ...	HTG Molecular Diagnostics	Research Use Only
HTG EdgeSeq Precision Immuno-Oncology Panel	Non Small Cell Lung Cancer	HTG Molecular Diagnostics	Research Use Only
HTG EdgeSeq miRNA Whole Transcriptome Assay	Lung Adenocarcinoma Lung Non-Small Cell Squamous Cancer	HTG Molecular Diagnostics	Research Use Only
HTG Transcriptome Panel	Breast Cancer Colorectal Cancer Lung Cancer ...	HTG Molecular Diagnostics	Research Use Only
Harbinger Health MCED Blood Test		Harbinger Health	Laboratory Developed Test
Haystack MRD™	Solid Tumor	Quest Diagnostics	Laboratory Developed Test
Hedera Profiling 2 ctDNA test panel	Solid Tumor	Hedera	Laboratory Developed Test
Helio Liver Test	Hepatocellular Cancer	Helio Genomics	Other Approval
HelioLiver Dx test	Hepatocellular Cancer	Helio Genomics	Laboratory Developed Test
Hemarna™	Acute Lymphocytic Leukemia Acute Myelogenous Leukemia Lymphoma ...	Geneseeq	CE Marked
Hemasalus™	Hematological Malignancies Leukemia Multiple Myeloma	Geneseeq	CE Marked
Hematology Profile Plus	Acute Lymphocytic Leukemia Acute Myelogenous Leukemia Diffuse Large B Cell Lymphoma ...	Genomic Testing Cooperative	CE Marked
HemeScreen™ Panel	Acute Myelogenous Leukemia Chronic Myeloid Leukemia Hematological Malignancies ...	Precipio	Research Use Only
HepatoPredict	Hepatocellular Cancer	Ophiomics	CE Marked
HercepTest	Breast Cancer Gastric Cancer Gastroesophageal Cancer	Agilent Tech	FDA Approved (PMA)
Hevylite® Heavy/Light Chain (HLC) Assay.	Multiple Myeloma	Thermo Fisher Scientific	FDA Cleared (510k)
Homologous Recombination Deficiency Detection Kit	Solid Tumor	BGI Group	CE-IVD (Old IVDD)
IDH1 R132H (MRQ-67) Rabbit Monoclonal Primary Antibody	Acute Myelogenous Leukemia Glioma	Roche	Laboratory Developed Test
IMMray™ PanCan-d	Pancreatic Cancer	Immunovia	Laboratory Developed Test
INFORM HER-2/neu	Breast Cancer	Roche	FDA Approved (PMA)
INFORM HER2 Dual ISH DNA Probe Cocktail	Breast Cancer	Roche	FDA Approved (PMA)
IOpener®	Melanoma Non Small Cell Lung Cancer	PamGene	CE-IVD (Old IVDD)
ISET®-AML test	Acute Myelogenous Leukemia	Rarecells	Laboratory Developed Test
Idylla™ ABC (Advanced Breast Cancer) Assay	Breast Cancer	Biocartis	Laboratory Developed Test
Idylla™ BRAF Mutation Test	Melanoma	Biocartis	CE-IVD (Old IVDD)
Idylla™ EGFR Mutation Test	Non Small Cell Lung Cancer	Biocartis	CE-IVD (Old IVDD)
Idylla™ EGFR-BRAF+ Mutation Assay	Non Small Cell Lung Cancer	Biocartis	Research Use Only
Idylla™ GeneFusion Assay	Melanoma Non Small Cell Lung Cancer Renal Cell Carcinoma ...	Biocartis	CE-IVD (Old IVDD)
Idylla™ IDH1-2 Mutation Assay	Acute Myelogenous Leukemia Cholangiocarcinoma Glioma ...	Biocartis	Research Use Only
Idylla™ KRAS Mutation Test	Colorectal Cancer	Biocartis	CE-IVD (Old IVDD)
Idylla™ MSI Test	Colorectal Cancer	Biocartis	CE Marked
Idylla™ NRAS-BRAF Mutation Test	Colorectal Cancer	Biocartis	CE-IVD (Old IVDD)
Idylla™ NRAS-BRAF-EGFR S492R Mutation Assay	Colorectal Cancer	Biocartis	Research Use Only
Idylla™ PIK3CA-AKT1 Mutation Assay	Breast Cancer	Biocartis	Research Use Only
Idylla™ POLE Mutation Assay	Colorectal Cancer Endometrial Cancer	Biocartis	Laboratory Developed Test
Idylla™ POLE-POLD1 Mutation Assay	Endometrial Cancer	Biocartis	Research Use Only
Idylla™ ctBRAF Mutation Assay	Melanoma	Biocartis	CE-IVD (Old IVDD)
Idylla™ ctEGFR Mutation Assay	Lung Cancer	Biocartis	Research Use Only
Idylla™ ctKRAS Mutation Test	Colorectal Cancer	Biocartis	CE Marked
Idylla™ ctNRAS-BRAF Mutation Test	Colorectal Cancer	Biocartis	CE Marked
Illumina Focus Panel	Solid Tumor	Illumina	Research Use Only
Illumina WGS MRD assay	Solid Tumor	Illumina	Research Use Only
Immune Checkpoint Inhibitor Predictive Response Signature	Solid Tumor	Genecentric	Laboratory Developed Test
Immune Profile Score Algorithmic Test	Solid Tumor	Tempus	Laboratory Developed Test
Immunoprint®	Melanoma	NeraCare	Laboratory Developed Test
Immunoscore®	Colon Cancer Colorectal Cancer	Veracyte	CE Marked
Immunoscore® IC Assay	Colorectal Cancer	Veracyte	CE Marked
Immunoscore® TCE test	Non Small Cell Lung Cancer	Veracyte	Laboratory Developed Test
InSite™ Her-2/neu Kit	Breast Cancer	BioGenex	FDA Approved (PMA)
InVisionFirst®-Lung	Non Small Cell Lung Cancer	NeoGenomics	Laboratory Developed Test
InVisionSeq™	Acute Myelogenous Leukemia Bladder Cancer Brain Cancer ...	NeoGenomics	Laboratory Developed Test
Invitae Common Hereditary Cancers Panel	Breast Cancer Colorectal Cancer Gastric Cancer ...	Invitae Corp	FDA Approved (PMA)
Invivoscribe FLT3-ITD MRD NGS Kit	Acute Myelogenous Leukemia	Invivoscribe Techno	Laboratory Developed Test
Ion AmpliSeq Colon and Lung Cancer Research Panel v2	Colon Cancer Lung Cancer	Thermo Fisher Scientific	Research Use Only
Ion AmpliSeq™ Cancer Hotspot Panel v2		Thermo Fisher Scientific	Research Use Only
Ipsogen JAK2 RGQ PCR Kit	Myeloproliferative Neoplasm	Qiagen
IsoPSA®	Prostate Cancer	Cleveland Diagnostics	Laboratory Developed Test
K-TRACK BO™	Solid Tumor	Gene Solutions	Laboratory Developed Test
K-TRACK™	Solid Tumor	Gene Solutions	Laboratory Developed Test
KRAS Gene Sequencing, KRAS Exons 2-4 (includes G12C mutation) Test	Non Small Cell Lung Cancer	NeoGenomics	Laboratory Developed Test
Ki-67 IHC MIB-1 pharmDx	Breast Cancer	Agilent Tech	FDA Approved (PMA)
LAG-3 IHC assay	Melanoma	LabCorp	Laboratory Developed Test
LENA PAN-MPN qPCR Panel	Leukemia Myeloproliferative Neoplasm	Alercell	Research Use Only
LENA Q51®	Leukemia	Alercell	CE Marked
Labcorp® Plasma Complete™	Solid Tumor	LabCorp	Laboratory Developed Test
Labcorp® Plasma Detect™	Solid Tumor	LabCorp	Laboratory Developed Test
Labcorp® Plasma Focus™	Breast Cancer Colorectal Cancer Esophageal Cancer ...	LabCorp	FDA Authorized (EUA/De Novo)
Latitude™ MRD Assay	Colorectal Cancer	Natera	Laboratory Developed Test
Lena S1®	Lung Cancer	Alercell	Laboratory Developed Test
Leukemia Fusion Genes Screening and Genotyping Kit	Leukemia	Zeesan	Laboratory Developed Test
Leukemia Q-Fusion Screening Kit	Leukemia	QuanDx	Research Use Only
LeukoPrint®	Acute Lymphocytic Leukemia Acute Myelogenous Leukemia Chronic Lymphocytic Leukemia ...	SeekIn	CE Marked
LeukoStrat® CDx FLT3 Mutation Assay	Acute Myelogenous Leukemia	Invivoscribe Techno
LifeKit® Prevent	Colorectal Cancer	SOLVD Health	Laboratory Developed Test
LightMix® BRAF V600E/K Kit	Colorectal Cancer Melanoma	Roche	Research Use Only
Liquid Biopsy Metabolic Panel	Breast Cancer Glioblastoma Head and Neck Cancer	Biomark Diagnostics	Laboratory Developed Test
Liquid Biopsy SSAT1 Assay	Gastrointestinal Cancer Glioblastoma Head and Neck Cancer ...	Biomark Diagnostics	Laboratory Developed Test
Liquid Trace Hematology Profile	Acute Myelogenous Leukemia Chronic Myelomonocytic Leukemia Lymphoma ...	Genomic Testing Cooperative	CE Marked
Liquid Trace Solid Tumor	Solid Tumor	Genomic Testing Cooperative	CE Marked
Liquid Trace™ Hematology	Acute Myelogenous Leukemia Chronic Myelomonocytic Leukemia Lymphoma ...	Genomic Testing Cooperative	Laboratory Developed Test
Liquid Trace™ Solid Tumor	Solid Tumor	Genomic Testing Cooperative	Laboratory Developed Test
LiquidGx™	Solid Tumor	Nucleos Healthcare	Laboratory Developed Test
LiquidHALLMARK®	Breast Cancer Colon Cancer Endometrial Cancer ...	Lucence	Laboratory Developed Test
LiquidLung™	Lung Cancer	IV BioHoldings	Laboratory Developed Test
LiquidMARK™ Bile Duct test	Biliary Tract Cancer	Lucence	Laboratory Developed Test
LiquidPlex™	Solid Tumor	Integrated DNA Technologies	Laboratory Developed Test
LucenceINSIGHT™		Lucence	Laboratory Developed Test
Lunar-2	Colorectal Cancer	Guardant Health	Laboratory Developed Test
Lung Cancer 8-Gene Kit	Lung Cancer	Genetron Health	CE Marked
Lung Cancer Circulating Tumor DNA Multi-gene Mutation Combined Detection Kit	Lung Cancer	BGI Group	CE Marked
Lung Cancer Mutation Panel	Non Small Cell Lung Cancer	Quest Diagnostics	Laboratory Developed Test
Lung EpiCheck®	Lung Cancer	Nucleix	Laboratory Developed Test
LungCanSeek® test	Lung Cancer	SeekIn	Laboratory Developed Test
LungCure™ CDx	Non Small Cell Lung Cancer	Burning Rock Biotech	Other Approval
Lunit INSIGHT DBT™	Breast Cancer	Lunit	Laboratory Developed Test
Lunit SCOPE Genotype Predictor	Non Small Cell Lung Cancer	Lunit	Laboratory Developed Test
Lunit SCOPE HER2	Breast Cancer	Lunit	Research Use Only
Lunit SCOPE IO	Biliary Tract Cancer Bladder Cancer Breast Cancer ...	Lunit	Research Use Only
Lunit SCOPE PD-L1		Lunit	CE-IVD (Old IVDD)
LymphMark™ Assay	Diffuse Large B Cell Lymphoma Lymphoma	Veracyte	Laboratory Developed Test
LymphoTrack® Dx IGH Assay	Leukemia Lymphoma Multiple Myeloma	Invivoscribe Techno	Research Use Only
LymphoTrack® Dx IGK Assay	Leukemia	Invivoscribe Techno	Laboratory Developed Test
LymphoTrack® TRB Assay Panel		Invivoscribe Techno	CE-IVD (Old IVDD)
LymphoTrack® TRG Assay		Invivoscribe Techno	Laboratory Developed Test
MAGE-A4 IHC 1F9 pharmDx (SK032)	Synovial Sarcoma	Agilent Tech	FDA Approved (PMA)
MEBGEN™ BRAF 3 Kit	Hairy Cell Leukemia Solid Tumor	JSR Life Sciences	Other Approval
MEBGEN™ BRAF Kit	Melanoma	JSR Life Sciences	Other Approval
MELAGENIX	Melanoma	NeraCare	Laboratory Developed Test
MERCURY™	Solid Tumor	Geneseeq	CE Marked
MI Cancer Seek™	Breast Cancer Colorectal Cancer Endometrial Cancer ...	Caris Life Sci	FDA Approved (PMA)
MI FOLFOXai	Colorectal Cancer	Caris Life Sci	Laboratory Developed Test
MI Tumor Seek™	Solid Tumor	Caris Life Sci	Laboratory Developed Test
MIRAM® kit	Brain Cancer Kidney Cancer	Elypta	Laboratory Developed Test
MLL (KMT2A) Breakapart Fish Probe Kit	Acute Myelogenous Leukemia Myelodysplastic Syndrome	Sysmex Corp	FDA Authorized (EUA/De Novo)
MLPA Kit		MRC Holland	CE-IVD (Old IVDD)
MRDVision		Inocras	Laboratory Developed Test
MRDaccuPanel™ AML FLT3-ITD	Acute Myelogenous Leukemia	NGeneBio	Laboratory Developed Test
MRDx BCR-ABL Test	Chronic Myeloid Leukemia	Icon plc	FDA Approved (PMA)
MSC miRNA test	Lung Cancer	AccuStem	Laboratory Developed Test
MSI-IVD Kit	Breast Cancer Colorectal Cancer Gastric Cancer ...	Promega	Other Approval
MSIntuit™ CRC	Colorectal Cancer	Owkin	CE-IVD (Old IVDD)
MSK-ACCESS	Solid Tumor	Memorial Sloan-Kettering Cancer Center	Laboratory Developed Test
MSK-IMPACT	Bladder Cancer Breast Cancer Cholangiocarcinoma ...	Memorial Sloan-Kettering Cancer Center	FDA Authorized (EUA/De Novo)
MSK-IMPACT Heme	Leukemia Lymphoma Multiple Myeloma	Memorial Sloan-Kettering Cancer Center	Laboratory Developed Test
MammaPrint®	Breast Cancer	Agendia
MammaTyper® Kit	Breast Cancer	BioNTech	CE Marked
Mammostrat® Breast Cancer Recurrence Assay	Breast Cancer	Cigna	Laboratory Developed Test
MelaNodal Predict™	Cutaneous Melanoma Melanoma	Quest Diagnostics	Laboratory Developed Test
MelanomaNext®	Melanoma	Tempus	Laboratory Developed Test
MeltPro® High Risk HPV Genotyping Assay	Cervical Cancer	Zeesan	CE-IVD (Old IVDD)
Mercy Halo™ Test	Ovarian Cancer Ovarian Serous Adenocarcinoma	Mercy Bio	Laboratory Developed Test
Merlin Assay	Melanoma	Skyline Dx	CE-IVD (Old IVDD)
MiCheck® Prostate	Prostate Cancer	Minomic	Laboratory Developed Test
Mitomic™ Prostate Test	Prostate Cancer	Aditxt	Laboratory Developed Test
MultiOmyx-RNAscope Assay		NeoGenomics	Laboratory Developed Test
MyProstateScore 2.0	Prostate Cancer	Lynx Dx	Laboratory Developed Test
Myeloid Molecular Profile	Acute Myelogenous Leukemia Myelodysplastic Syndrome	NeoGenomics	Laboratory Developed Test
Myriad myChoice® CDx	Ovarian Cancer	Myriad Genetics	FDA Approved (PMA)
Myriad myChoice® CDx Plus	Ovarian Cancer	Myriad Genetics	CE Marked
Myriad myRisk® Hereditary Cancer	Breast Cancer Colorectal Cancer Endometrial Cancer ...	Myriad Genetics	Laboratory Developed Test
Myriapod® NGS BRCA1-2 panel CE IVD kit	Breast Cancer Ovarian Cancer Pancreatic Cancer ...	Diatech Pharmacogenetics	CE-IVDR (New IVDR)
NEO-MRD® assay	Breast Cancer Colorectal Cancer Head and Neck Cancer ...	NeoGenomics	CE Marked
NETest®	Neuroendocrine Tumor	Wren Laboratories	Laboratory Developed Test
NGS Targeted Hotspot Panel	Acute Myelogenous Leukemia Bladder Cancer Breast Cancer ...	EntroGen	CE-IVD (Old IVDD)
NOVOPM panel	Solid Tumor	Novogene	Laboratory Developed Test
NPM1 Mutation Assay	Acute Lymphocytic Leukemia	Invivoscribe Techno	Laboratory Developed Test
NVIGEN X™		NVIGEN	Laboratory Developed Test
NYU Langone Genome PACT assay	Solid Tumor	NYU Langone Health	FDA Cleared (510k)
NavDx®	Head and Neck Cancer	Naveris	Laboratory Developed Test
NeXT Dx™ Test	Solid Tumor	Personalis	Laboratory Developed Test
NeXT Personal™	Solid Tumor	Personalis	Research Use Only
Neo Comprehensive - Myeloid Disorders Assay	Acute Myelogenous Leukemia Chronic Myeloid Leukemia Chronic Myelomonocytic Leukemia ...	NeoGenomics	Laboratory Developed Test
Neo Comprehensive - Solid Tumor Assay	Solid Tumor	NeoGenomics	Laboratory Developed Test
Neo Comprehensive™ - Heme Cancers	Acute Myelogenous Leukemia	NeoGenomics	Laboratory Developed Test
NeoLAB® Solid Tumor Liquid Biopsy	Bladder Cancer Breast Cancer Colorectal Cancer ...	NeoGenomics	Laboratory Developed Test
NeoTYPE® Lung Tumor Profile	Lung Cancer	NeoGenomics	Laboratory Developed Test
NeuMoDx HPV Test Strip	Cervical Cancer	Qiagen	Laboratory Developed Test
NexCourse®	Hematological Malignancies Solid Tumor	NeoGenomics	Laboratory Developed Test
Next-Gen CRC Screening Test	Colorectal Cancer	Epigenomics	Laboratory Developed Test
Nodify CDT™	Lung Cancer Non Small Cell Lung Cancer	Biodesix	Laboratory Developed Test
Nodify Lung	Lung Cancer	Biodesix	Laboratory Developed Test
Nodify XL2™	Lung Cancer	Biodesix	Laboratory Developed Test
Non-Small Cell Lung Cancer Tumor Mutational Burden Test Kit	Non Small Cell Lung Cancer	Geneseeq	Other Approval
Northstar Response™		BillionToOne	Laboratory Developed Test
Northstar Select™	Solid Tumor	BillionToOne	Laboratory Developed Test
NovoFocus™ CRC 2.0	Colorectal Cancer	Novogene	Laboratory Developed Test
NovoFocus™ NSCLC 2.0 Test	Non Small Cell Lung Cancer	Novogene	Other Approval
NovoFocus™ PARPi CDx	Colon Cancer HER2 Negative Breast Cancer Ovarian Cancer ...	Novogene	Laboratory Developed Test
NovoPM™ 2.0	Solid Tumor	Novogene	Laboratory Developed Test
Nu.Q® Lung Cancer Test	Lung Cancer	Volition	Laboratory Developed Test
ONCO/Reveal™ Essential MPN Panel	Myeloproliferative Neoplasm	Pillar Biosci	Laboratory Developed Test
ONCOCATCH-CDx	Solid Tumor	Eone Diagnomics Genome Center	Laboratory Developed Test
ONCOCATCH-E	Breast Cancer Colon Cancer Gastric Cancer	Eone Diagnomics Genome Center	Laboratory Developed Test
ONCOCATCH-S	Lung Cancer	Eone Diagnomics Genome Center	Laboratory Developed Test
Omics Core	Solid Tumor	NantHealth	FDA Cleared (510k)
OmniSeq INSIGHT	Solid Tumor	LabCorp	Other Approval
Onco PanScan™	Solid Tumor	Genetron Health	CE Marked
Onco-ID: Breast	Breast Cancer	Syantra	Laboratory Developed Test
OncoAssure Prostate Cancer Test	Prostate Cancer	OncoAssure	Laboratory Developed Test
OncoAtlas Driver	Solid Tumor	Oncoatlas	Laboratory Developed Test
OncoBEAM EGFR v2 Kit	Non Small Cell Lung Cancer	Sysmex Corp	Research Use Only
OncoBEAM RAS CRC kit	Colorectal Cancer	Sysmex Corp	CE-IVD (Old IVDD)
OncoBEAM™ BRAF Kit	Colorectal Cancer Melanoma	Sysmex Corp	Research Use Only
OncoCompass™ Target	Non Small Cell Lung Cancer	Burning Rock Biotech	CE Marked
OncoDEEP	Solid Tumor	OncoDNA	Laboratory Developed Test
OncoExTra™ test	Solid Tumor	Exact Sciences Corp	Laboratory Developed Test
OncoFOLLOW	Solid Tumor	OncoDNA	Laboratory Developed Test
OncoGuide™ EpiLight™ Methylation Detection Kit	Colorectal Cancer	Riken Genesis	Other Approval
OncoGuide™ NCC Oncopanel System	Solid Tumor	Sysmex Corp	Other Approval
OncoGxOne™	Solid Tumor	Admera Health	Laboratory Developed Test
OncoIndx® Assay	Solid Tumor	1Cell.AI	Laboratory Developed Test
OncoKey™ SL 525 Plus Assay	Bladder Cancer Breast Cancer CNS Tumor ...	Luye Group	Laboratory Developed Test
OncoKey™ SL 60 Plus Assay	Bladder Cancer Breast Cancer Colorectal Cancer ...	Luye Group	Research Use Only
OncoKitDx	Solid Tumor	Healthincode	CE-IVD (Old IVDD)
OncoMasTR test	Bladder Cancer Breast Cancer Colorectal Cancer ...	Danaher Corp	CE Marked
OncoMate™ MSI	Solid Tumor	Promega	CE Marked
OncoPanel™ Assay	Colorectal Cancer Gastrointestinal Stromal Tumor Lung Cancer ...	Cancer Genetics and Genomics Laboratory	Laboratory Developed Test
OncoPlus	Hematological Malignancies Solid Tumor	University of Chicago	Laboratory Developed Test
OncoPrism™ Assay	Squamous Cell Carcinoma of Head and Neck	Cofactor Genomics	Laboratory Developed Test
OncoReveal™ BRCA1 & BRCA2 plus CNV Panel		Pillar Biosci	Research Use Only
OncoReveal™ Dx Lung and Colon Cancer Assay (O/RDx-LCCA)	Colorectal Cancer Non Small Cell Lung Cancer	Pillar Biosci	FDA Approved (PMA)
OncoReveal™ Myeloid Panel	Pancreatic Cancer Solid Tumor	Pillar Biosci	Research Use Only
OncoReveal™ Solid Tumor Panel	Solid Tumor	Pillar Biosci	Research Use Only
OncoSELECT	Breast Cancer Colorectal Cancer Non Small Cell Lung Cancer	OncoDNA	Research Use Only
OncoSTRAT&GO	Colorectal Cancer Non Small Cell Lung Cancer Ovarian Cancer ...	OncoDNA	CE Marked
OncoScan™ CNV Assay		Thermo Fisher Scientific	Laboratory Developed Test
OncoScan™ CNV Plus Assay	Brain Cancer	Thermo Fisher Scientific	Research Use Only
OncoScreen Plus®	Colorectal Cancer Endometrial Cancer Gastric Cancer ...	Burning Rock Biotech	CE Marked
OncoScreen™ Focus CDx Tissue Kit	Colorectal Cancer Gastrointestinal Stromal Tumor Non Small Cell Lung Cancer	Burning Rock Biotech	CE Marked
OncoScreen™ IO	Bladder Cancer Breast Cancer Colorectal Cancer ...	Burning Rock Biotech	Laboratory Developed Test
OncoSeek®		SeekIn	CE Marked
OncoSignal™	Breast Cancer Colon Cancer Lymphoma ...	InnoSIGN	Research Use Only
OncoSignature® Test	Endometrial Cancer Ovarian Cancer Urothelial Cancer	Acrivon Therap	Laboratory Developed Test
OncoSweep™	Pancreatic Ductal Adenocarcinoma	Pharus Diagnostics	Laboratory Developed Test
OncoTarget® 500	Solid Tumor	GoPath Lab	CE Marked
OncoTect iO® Bladder Kit	Bladder Cancer	InCellDx	CE-IVD (Old IVDD)
OncoTect iO® Lung Kit	Non Small Cell Lung Cancer	InCellDx	CE Marked
OncoXPLORE®	Unspecified Cancer	OncoDNA	Laboratory Developed Test
OncoaccuPanel™	Breast Cancer Colon Cancer Gastric Cancer ...	NGeneBio	CE Marked
OncobiotaLUNG assay	Lung Cancer	Micronoma	Laboratory Developed Test
OncodetectTM MRD Test	Solid Tumor	Exact Sciences Corp	Laboratory Developed Test
Oncoguard® Esophagus Test	Esophageal Adenocarcinoma	Exact Sciences Corp	Laboratory Developed Test
Oncoguard™ Liver	Hepatocellular Cancer	Exact Sciences Corp	Laboratory Developed Test
Oncomap™ ExTra test	Solid Tumor	Exact Sciences Corp	Laboratory Developed Test
Oncomine Dx Express Test	Non Small Cell Lung Cancer	Thermo Fisher Scientific	CE Marked
Oncomine Focus Assay	Solid Tumor	Thermo Fisher Scientific	Research Use Only
Oncomine Lung Cell-Free Total Nucleic Acid Research Assay	Lung Cancer	Thermo Fisher Scientific	Research Use Only
Oncomine Myeloid Assay GX	Acute Myelogenous Leukemia Chronic Myeloid Leukemia Chronic Myelomonocytic Leukemia ...	Thermo Fisher Scientific	Laboratory Developed Test
Oncomine Myeloid Research Assay	Acute Myelogenous Leukemia Chronic Myeloid Leukemia Chronic Myelomonocytic Leukemia ...	Thermo Fisher Scientific	Research Use Only
Oncomine Precision Assay	Breast Cancer Colon Cancer Endometrial Cancer ...	Thermo Fisher Scientific	Research Use Only
Oncomine Solid Tumor DNA Kit	Solid Tumor	Thermo Fisher Scientific	CE Marked
Oncomine Tumor Mutation Load Assay	Colon Cancer	Thermo Fisher Scientific	Research Use Only
Oncomine™ BCR IGH-LR Assay	Acute Myelogenous Leukemia Leukemia	Thermo Fisher Scientific	Research Use Only
Oncomine™ BCR IGH-SR Assay	Acute Myelogenous Leukemia Leukemia	Thermo Fisher Scientific	Research Use Only
Oncomine™ BCR IGHV Leader-J Assay	Chronic Lymphocytic Leukemia	Thermo Fisher Scientific	Research Use Only
Oncomine™ BCR Pan-Clonality Assay		Thermo Fisher Scientific	Research Use Only
Oncomine™ BRCA Research Assay	Breast Cancer Ovarian Cancer	Thermo Fisher Scientific	Research Use Only
Oncomine™ Breast cfDNA Assay	Breast Cancer	Thermo Fisher Scientific	Research Use Only
Oncomine™ Childhood Cancer Research Assay	Childhood B Acute Lymphoblastic Leukemia	Thermo Fisher Scientific	Research Use Only
Oncomine™ Colon cfDNA Assay	Colon Cancer Gastrointestinal Cancer	Thermo Fisher Scientific	Research Use Only
Oncomine™ Comprehensive Assay Plus	Colon Cancer Thyroid Gland Carcinoma	Thermo Fisher Scientific	Research Use Only
Oncomine™ Comprehensive Assay v3M	Solid Tumor	Thermo Fisher Scientific	Research Use Only
Oncomine™ Dx Target Test	Glioma Non Small Cell Lung Cancer Thyroid Gland Medullary Carcinoma	Thermo Fisher Scientific
Oncomine™ IGH FR1-J Assay		Thermo Fisher Scientific	Research Use Only
Oncomine™ Immune Response Research Assay	Leukemia Lymphoma Solid Tumor	Thermo Fisher Scientific	Research Use Only
Oncomine™ Lung cfDNA Assay	Non Small Cell Lung Cancer	Thermo Fisher Scientific	Research Use Only
Oncomine™ Lymphoma Panel	Diffuse Large B Cell Lymphoma Hodgkin Lymphoma Non-Hodgkin’s Lymphoma	Thermo Fisher Scientific	Research Use Only
Oncomine™ Myeloid MRD Assays	Acute Myelogenous Leukemia Myelodysplastic Syndrome Myeloproliferative Neoplasm	Thermo Fisher Scientific	Research Use Only
Oncomine™ Pan-Cancer Cell-Free Assay	Non Small Cell Lung Cancer	Thermo Fisher Scientific	Research Use Only
Oncomine™ TCR Beta-LR Assay		Thermo Fisher Scientific	Research Use Only
Oncomine™ TCR Beta-SR Assay		Thermo Fisher Scientific	Research Use Only
Oncomine™ TCR Pan-Clonality Assay	Acute Myelogenous Leukemia	Thermo Fisher Scientific	Laboratory Developed Test
Oncotype DX AR-V7 Nucleus Detect® test	Prostate Cancer	Exact Sciences Corp	Laboratory Developed Test
Oncotype DX Breast DCIS Score test	Breast Cancer	Exact Sciences Corp	Laboratory Developed Test
Oncotype DX Breast Recurrence Score®Test	Breast Cancer	Exact Sciences Corp	Laboratory Developed Test
Oncotype DX Genomic Prostate Score® Assay	Prostate Cancer	Exact Sciences Corp	Laboratory Developed Test
Oncotype DX® Colon Recurrence Score test	Colon Cancer	Exact Sciences Corp	Laboratory Developed Test
Oncotype MAP™ Pan-Cancer Tissue Test	Solid Tumor	Exact Sciences Corp	Laboratory Developed Test
Oncuria™	Bladder Cancer	Nonagen BioSci	CE Marked
One-Step Nucleic Acid Amplification (OSNA) Assay	Breast Cancer	Sysmex Corp	Other Approval
OptiSeq™ BRCA1 and BRCA2 Panel		DiaCarta	Laboratory Developed Test
OptiSeq™ Colorectal Cancer Panel	Colorectal Cancer	DiaCarta	Research Use Only
OptiSeq™ Lung Cancer & Colon Cancer Early Detection Panel	Colon Cancer Lung Cancer	DiaCarta	Laboratory Developed Test
OptiSeq™ Lung Cancer Panel	Lung Cancer	DiaCarta	Laboratory Developed Test
OptiSeq™ Pan-Cancer Gene Panel	Leukemia Lymphoma Solid Tumor	DiaCarta	Research Use Only
OvaCis®	Ovarian Cancer	INEX Innovate	CE Marked
OvaME	Ovarian Cancer	GenoME Diagnostics	Laboratory Developed Test
OvaNext®	Breast Cancer Ovarian Cancer Uterine Cancer	Tempus	Laboratory Developed Test
OverC™		Burning Rock Biotech	CE Marked
P53 (TP53) Deletion FISH Probe Kit	Acute Myelogenous Leukemia Myelodysplastic Syndrome	Sysmex Corp	FDA Authorized (EUA/De Novo)
PANA Realtyper™ HPV screening kit	Cervical Cancer	Panagene	Other Approval
PANAMutyper™ R EGFR	Lung Cancer	Panagene	CE-IVD (Old IVDD)
PANAMutyper™ R KRAS	Colorectal Cancer Lung Cancer	Panagene	Other Approval
PANAMutyper™ ROS1	Non Small Cell Lung Cancer	Panagene	Other Approval
PANEXIA™	Pancreatic Cancer	Myriad Genetics	Laboratory Developed Test
PATHWAY antiHer2/neu (4B5) Rabbit Monoclonal Primary Antibody	Breast Cancer Gastric Cancer	Roche
PD-L1 IHC 22C3 pharmDx	Cervical Cancer Esophageal Squamous Cell Carcinoma Gastric Adenocarcinoma ...	Agilent Tech
PD-L1 IHC 28-8 pharmDx	Esophageal Squamous Cell Carcinoma Lung Non-Squamous Non-Small Cell Cancer Melanoma ...	Agilent Tech
PD-L1 IHC 73-10 pharmDx	Non Small Cell Lung Cancer	Agilent Tech	Laboratory Developed Test
PDACatch assay	Pancreatic Adenocarcinoma	Singlera Genomics	Laboratory Developed Test
PDGFRB FISH Assay	Myelodysplastic Syndrome Myeloproliferative Neoplasm	ARUP Laboratories	FDA Approved (PMA)
PGDx elio® plasma focus™ Dx	Solid Tumor	LabCorp	FDA Authorized (EUA/De Novo)
PGDx elio™ plasma resolve assay	Solid Tumor	LabCorp	CE Marked
PGDx elio™ tissue complete assay	Solid Tumor	LabCorp	FDA Cleared (510k)
PGLNext®	Glioma	Tempus	Laboratory Developed Test
PROGENSA PCA3 Assay	Prostate Cancer	Hologic
PROSTATENOW™	Prostate Cancer	GoPath Lab	Laboratory Developed Test
PROSTest®	Prostate Cancer	Wren Laboratories	Laboratory Developed Test
Pan-cancer OncoReveal™ CDx	Colorectal Cancer Non Small Cell Lung Cancer Pancreatic Cancer	Pillar Biosci	FDA Approved (PMA)
PanCanSeek®	Leukemia	SeekIn	CE-IVD (Old IVDD)
PanHeme assay	Leukemia Lymphoma Multiple Myeloma	Roswell Park Comprehensive Cancer Center	Laboratory Developed Test
PanTracer LBx™ Assay	Solid Tumor	NeoGenomics	Laboratory Developed Test
PanTracer™ Tissue	Solid Tumor	NeoGenomics	Laboratory Developed Test
PanTracer™ Tissue + HRD	Ovarian Cancer	NeoGenomics	Laboratory Developed Test
PancAlert	Pancreatic Cancer	Mainz BioMed	Laboratory Developed Test
PancNext®	Pancreatic Cancer	Konica Minolta	Laboratory Developed Test
PancraGEN®	Pancreatic Cancer	Interpace Biosci	Laboratory Developed Test
PapilloCheck®	Cervical Cancer	Greiner Bio	CE-IVD (Old IVDD)
Parsortix Liquid Biopsy	Breast Cancer	ANGLE	FDA Authorized (EUA/De Novo)
PathVysion HER-2 DNA Probe Kit	Breast Cancer	Abbott	FDA Approved (PMA)
Pathlight™ MRD test	Breast Cancer Solid Tumor	SAGA Diagnostics	Laboratory Developed Test
Personalized Cancer Monitoring (PCM™)	Solid Tumor	Invitae Corp	Research Use Only
PhasED-Seq™ ctDNA assay		Foresight Diagnostics	Laboratory Developed Test
Plasma-SeqSensei™ CRC Kit	Colorectal Cancer	Sysmex Corp	Research Use Only
Plasma-SeqSensei™ NSCLC Kit	Non Small Cell Lung Cancer	Sysmex Corp	Research Use Only
Plasma-SeqSensei™ Solid Cancer IVD Kit	Solid Tumor	Sysmex Corp	CE-IVD (Old IVDD)
Portrait Flex assay	Solid Tumor	ANGLE	Laboratory Developed Test
Portrait HER2 assay	Breast Cancer	ANGLE	Laboratory Developed Test
Portrait® PD-L1 test	Lung Cancer Solid Tumor	ANGLE	Research Use Only
Praxis Extended RAS Panel	Colorectal Cancer	Illumina	FDA Approved (PMA)
PreCursor-M AnoGYN Methylation Assay	Anal Carcinoma	Self-screen	Research Use Only
PreciseDx Breast Test	Breast Cancer	PreciseDx	Laboratory Developed Test
Precise™ Liquid	Solid Tumor	Myriad Genetics	Laboratory Developed Test
Precise™ MRD		Myriad Genetics	Laboratory Developed Test
Precise™ Tumor Molecular Profile Test	Solid Tumor	Myriad Genetics	Laboratory Developed Test
Precursor-M+/QIAsure Methylation Test	Cervical Cancer	Self-screen	CE Marked
PredicineALERT™		Predicine	Laboratory Developed Test
PredicineATLAS™	Biliary Tract Cancer Solid Tumor	Predicine	Laboratory Developed Test
PredicineBEACON™	Bladder Cancer Prostate Cancer Renal Cell Carcinoma ...	Predicine	Laboratory Developed Test
PredicineCARE™	Bladder Cancer	Predicine	CE Marked
PredicineCNB™	Bladder Cancer Prostate Cancer	Predicine	Laboratory Developed Test
PredicineCOMPLETE™		Predicine	Laboratory Developed Test
PredicineHEME™	Chronic Lymphocytic Leukemia Diffuse Large B Cell Lymphoma Mantle Cell Lymphoma ...	Predicine	Research Use Only
PredicineWES+™	Leukemia Lymphoma Solid Tumor	Predicine	Laboratory Developed Test
ProMark™	Prostate Cancer	Metamark Genetics	Laboratory Developed Test
Proclarix®	Prostate Cancer	Onconetix	CE-IVD (Old IVDD)
Prolaris®	Prostate Cancer	Myriad Genetics	CE Marked
Prosigna™ Breast Cancer Prognostic Gene Signature Assay	Breast Cancer	NanoString Technologies	FDA Cleared (510k)
Prostadiag®	Prostate Cancer	OncoDiag	Laboratory Developed Test
ProstateNext®	Prostate Cancer	Tempus	Laboratory Developed Test
Prostatype®	Prostate Cancer	Prostatype Genomics	CE Marked
PulmoSeek Lung Cancer Early Detection Assay	Lung Cancer	AnchorDx	CE Marked
PurIST℠ Test	Pancreatic Ductal Adenocarcinoma	Tempus	Laboratory Developed Test
QClamp® BRAF Mutation Detection Test	Colorectal Cancer Lung Adenocarcinoma Lung Cancer ...	DiaCarta	CE-IVD (Old IVDD)
QClamp® EGFR Mutation Detection Test	Colorectal Cancer	DiaCarta	CE-IVD (Old IVDD)
QClamp® JAK2 Mutation Detection Test	Myelofibrosis Polycythemia Vera	DiaCarta	CE-IVD (Old IVDD)
QClamp® KRAS Mutation Detection Test	Colorectal Cancer	DiaCarta	CE-IVD (Old IVDD)
QClamp® NRAS Mutation Detection Kit	Colorectal Cancer	DiaCarta	CE-IVD (Old IVDD)
QClamp® PIK3CA Mutation Detection Test		DiaCarta	CE-IVD (Old IVDD)
QFusion™ EML4-ALK and KIF5B-ALK Fusion Gene Detection Test	Non Small Cell Lung Cancer	DiaCarta	CE-IVD (Old IVDD)
QIAcuity Digital PCR IVD Assay		Qiagen	Laboratory Developed Test
QVantageᵀᴹ	Breast Cancer Colon Cancer Ovarian Cancer ...	Quest Diagnostics	Laboratory Developed Test
QXDx™ BCR-ABL %IS Kit	Chronic Myeloid Leukemia	Bio-Rad
QuantideX® qPCR ESR1 exoMutation Kit	Breast Cancer	Bio-Techne	Research Use Only
Quantidex qPCR BCR-ABL IS Kit	Acute Lymphocytic Leukemia Acute Myelogenous Leukemia Chronic Myeloid Leukemia	Bio-Techne
Quantitative BCR-ABL 2.0 Panel	Chronic Myeloid Leukemia	Precipio	Laboratory Developed Test
RAS-RAF-SEQ Assay		Sysmex Corp	Laboratory Developed Test
RNA-FIT assay	Colorectal Cancer Gastric Cancer	Geneoscopy	Laboratory Developed Test
RNAscope™ ISH Probe High Risk HPV	Head and Neck Cancer Oropharyngeal Cancer	Bio-Techne	CE Marked
RaDaR™ assay	Hematological Malignancies Non Small Cell Lung Cancer	NeoGenomics	CE Marked
RadTox™ Test		DiaCarta	CE-IVD (Old IVDD)
Radiotron™	Solid Tumor	Geneseeq	Laboratory Developed Test
RarePlex® ARv7/Synaptophysin CTC Panel Kit	Prostate Cancer	RareCyte	Research Use Only
RecurIndex®	Breast Cancer	Amwise Diagnostics	Laboratory Developed Test
RenalNext™	Renal Cell Carcinoma	Tempus	Laboratory Developed Test
Resolution HRD assay	Prostate Cancer	Exact Sciences Corp	Laboratory Developed Test
Resolution ctDx FIRST Assay	Non Small Cell Lung Cancer	Exact Sciences Corp	FDA Approved (PMA)
Resolution ctDx Lung Assay™	Non Small Cell Lung Cancer	Exact Sciences Corp	Laboratory Developed Test
Riskguard™ Hereditary Cancer Test	Breast Cancer Colorectal Cancer Endocrine Cancer ...	Exact Sciences Corp	Laboratory Developed Test
RlapsRisk™ BC	Breast Cancer	Owkin	CE-IVD (Old IVDD)
SAGAsafe® 24-plex PIK3CA mutation detection assay	Breast Cancer	SAGA Diagnostics	Laboratory Developed Test
SAGAsafe® EGFR T790M Assay	Non Small Cell Lung Cancer	SAGA Diagnostics	CE-IVD (Old IVDD)
SHIELDING™	Solid Tumor	Geneseeq	CE Marked
SKY92 Test	Multiple Myeloma	Skyline Dx	Laboratory Developed Test
SOLIDaccuTest DNA	Breast Cancer Colorectal Cancer Lung Cancer ...	NGeneBio	CE Marked
SOPHiA DDM Dx RNAtarget Oncology Solution	Lung Cancer	Sophia Genetics	CE-IVD (Old IVDD)
SOPHiA DDM HRD Solution	Ovarian Cancer	Sophia Genetics	CE-IVD (Old IVDD)
SOPHiA DDM™ Myeloid Solution	Leukemia Myelodysplastic Syndrome Myeloproliferative Neoplasm	Sophia Genetics	Research Use Only
SOPHiA DDM™ Solid Tumor Plus Solution	Brain Cancer Colorectal Cancer Lung Cancer ...	Sophia Genetics	Research Use Only
SOPHiA Myeloid Plus Solution	Leukemia Myelodysplastic Syndrome Myeloproliferative Neoplasm	Sophia Genetics	Research Use Only
SPOT-LIGHT HER2 CISH Kit	Breast Cancer	Thermo Fisher Scientific	FDA Approved (PMA)
SPOT-MAS Test	Biliary Tract Cancer Breast Cancer Colorectal Cancer ...	Gene Solutions	Laboratory Developed Test
STLA101 Test	Esophageal Cancer	Stella Diagnostics	Laboratory Developed Test
SafeSEQ AML MRD Assay	Acute Myelogenous Leukemia	Sysmex Corp	Laboratory Developed Test
SafeSEQ CRC MRD assay	Colorectal Cancer	Sysmex Corp	Laboratory Developed Test
SafeSEQ HNSCC assay	Squamous Cell Carcinoma of Head and Neck	Sysmex Corp	Laboratory Developed Test
SafeSEQ HPV Test	Anal Carcinoma Cervical Cancer Squamous Cell Carcinoma of Head and Neck	Sysmex Corp	Laboratory Developed Test
ScreenFire HPV Risk Stratification Assay	Cervical Cancer	Atila Biosystems	CE-IVD (Old IVDD)
SeCore CDx HLA Sequencing System	Synovial Sarcoma Uveal Melanoma	Thermo Fisher Scientific	Laboratory Developed Test
SeekInCare™		SeekIn	CE-IVD (Old IVDD)
SeekInClarity®	Leukemia Lymphoma Solid Tumor	SeekIn	CE Marked
SeekInCure®	Pancreatic Cancer	SeekIn	CE Marked
Sel-Cap Lung Cancer Panel	Non Small Cell Lung Cancer	Seasun Biomaterials	Other Approval
SelectMDx	Prostate Cancer	MDxHealth	CE Marked
Sema4 Signal®	Solid Tumor	GeneDx	Laboratory Developed Test
Sentinel Prostate Test™	Prostate Cancer	miR Scientific	Laboratory Developed Test
Seq-MRD® assay	B Acute Lymphoblastic Leukemia Chronic Lymphocytic Leukemia Multiple Myeloma	Genetron Health	CE Marked
Signal-C®	Colorectal Cancer	Universal DX	Laboratory Developed Test
Signal-X™	Colorectal Cancer Gastric Cancer Liver Cancer ...	Universal DX	Laboratory Developed Test
Signatera™	Bladder Cancer Breast Cancer Colorectal Cancer ...	Natera	CE Marked
SimpleScreen™ CRC blood test	Colorectal Cancer	Freenome	Laboratory Developed Test
Solid Tumor Multi-gene Combined Detection Kit	Solid Tumor	BGI Group	CE Marked
Solid Tumor Profile Plus	Solid Tumor	Genomic Testing Cooperative	CE Marked
Sophia Genetics Hereditary Cancer Syndrome (HCS) panel	Breast Cancer Gastrointestinal Cancer Ovarian Cancer	Sophia Genetics	CE-IVD (Old IVDD)
Status® BTA	Bladder Cancer	LifeSign	CE Marked
StemPrintER™	Estrogen Receptor Positive Breast Cancer HER2 Negative Breast Cancer	AccuStem	Laboratory Developed Test
Stockholm3	Prostate Cancer	A3P Biomedical	Laboratory Developed Test
Strata Select™	Solid Tumor	Strata Oncology	Laboratory Developed Test
StrataMRD™ test	Solid Tumor	Strata Oncology	Laboratory Developed Test
StrataNGS™ Test	Solid Tumor	Strata Oncology	Laboratory Developed Test
Stratafide™ CDx	Solid Tumor	Illumina	Laboratory Developed Test
SureSeq CLL + CNV V3 NGS Panel	Chronic Lymphocytic Leukemia	Sysmex Corp	Research Use Only
SureSeq™ CLL + CNV Panel	Chronic Lymphocytic Leukemia	Sysmex Corp	Research Use Only
SureSeq™ Germline Breast Cancer + CNV Panel	Breast Cancer	Sysmex Corp	Research Use Only
SureSeq™ Myeloid Fusion Panel	Acute Lymphocytic Leukemia Acute Myelogenous Leukemia	Sysmex Corp	Research Use Only
SureSeq™ Myeloid MRD Panel	Acute Myelogenous Leukemia Myelodysplastic Syndrome Myeloproliferative Neoplasm	Sysmex Corp	Research Use Only
SureSeq™ Myeloid Plus Panel	Acute Myelogenous Leukemia Chronic Myeloid Leukemia	Sysmex Corp	Research Use Only
SureSeq™ Pan-Myeloid Panel	Acute Myelogenous Leukemia Myelodysplastic Syndrome Myeloproliferative Neoplasm	Sysmex Corp	Research Use Only
Syantra DX™ Breast Cancer test	Breast Cancer	Syantra	CE Marked
THXID® BRAF Kit	Melanoma	bioMérieux	FDA Approved (PMA)
TNBCDX®	Triple Negative Breast Cancer	Reveal Genomics	Laboratory Developed Test
TNBCType-IM assay	Triple Negative Breast Cancer	Oncocyte	Laboratory Developed Test
TOP2A FISH pharmDx Kit	Breast Cancer	Agilent Tech	FDA Approved (PMA)
TSO 500 ctDNA v2 Assay	Pancreatic Cancer Solid Tumor	Illumina	Research Use Only
Target Selector™ BRAF Mutation Assay	Melanoma	Biocept	Laboratory Developed Test
Target Selector™ EGFR Mutation Assay	Non Small Cell Lung Cancer	Biocept	CE Marked
Target Selector™ NGS Lung Panel	Non Small Cell Lung Cancer	Quest Diagnostics	Laboratory Developed Test
TargetPrint®	Breast Cancer	Agendia	Laboratory Developed Test
TeloViewSMM test	Multiple Myeloma	Telogenomics	Laboratory Developed Test
Tempus HLA-LOH assay	Solid Tumor	Tempus	Laboratory Developed Test
Tempus HRD test	Breast Cancer Non Small Cell Lung Cancer Ovarian Cancer ...	Tempus	Laboratory Developed Test
Tempus TO		Tempus	Laboratory Developed Test
Tempus xE		Tempus	Laboratory Developed Test
Tempus xF Assay	Solid Tumor	Tempus	Laboratory Developed Test
Tempus xF Monitor assay		Tempus	Laboratory Developed Test
Tempus xF+ Panel	Bladder Cancer Breast Cancer Cholangiocarcinoma ...	Tempus	Laboratory Developed Test
Tempus xG	Brain Cancer Breast Cancer Colorectal Cancer ...	Tempus	Laboratory Developed Test
Tempus xG+		Tempus	Laboratory Developed Test
Tempus xH assay	Acute Myelogenous Leukemia Myelodysplastic Syndrome	Tempus	Laboratory Developed Test
Tempus xM	Colorectal Cancer	Tempus	Laboratory Developed Test
Tempus xO assay	Solid Tumor	Tempus	Laboratory Developed Test
Tempus xR	Solid Tumor	Tempus	FDA Approved (PMA)
Tempus xT Assay	Colorectal Cancer Solid Tumor	Tempus
TheraMap Test	Solid Tumor	Myriad Genetics	Laboratory Developed Test
TheraPrint® test	Breast Cancer	Agendia	Laboratory Developed Test
TheraSure™-CNI MONITOR Assay	Solid Tumor	Oncocyte	Laboratory Developed Test
Theralink Assay	Breast Cancer Colorectal Cancer Non Small Cell Lung Cancer ...	Theralink	Laboratory Developed Test
ThyGeNEXT® + ThyraMIR®	Thyroid Gland Carcinoma Thyroid Gland Papillary Carcinoma	Interpace Biosci	Laboratory Developed Test
Thyroid GuidePx®	Thyroid Gland Papillary Carcinoma	Protean BioDiagnostics	Laboratory Developed Test
ThyroidPrint©	Thyroid Gland Carcinoma	GeneproDx	Laboratory Developed Test
Tissue Of Origin Test Kit - FFPE	Bladder Cancer Breast Cancer Colorectal Cancer ...	Vyant Bio	FDA Cleared (510k)
TissueCypher Barrett’s Esophagus Test	Barrett Esophagus Esophageal Adenocarcinoma	Castle Biosci	Laboratory Developed Test
Todai OncoPanel (TOP)	Breast Cancer Melanoma Non Small Cell Lung Cancer	University of Tokyo Hospital	Other Approval
Trailblaze Pharos™	Solid Tumor	Roche	CE Marked
TriNetra™	Breast Cancer	Datar Cancer Genetics	CE Marked
TriNetra™-Glio	Brain Cancer	Datar Cancer Genetics	CE Marked
TruBlood®	Bladder Cancer Breast Cancer CNS Tumor ...	Datar Cancer Genetics	CE Marked
TruSeq®Amplicon - Cancer Panel	Triple Negative Breast Cancer	Illumina	Research Use Only
TruSight Hereditary Cancer Panel		Illumina	Research Use Only
TruSight Myeloid Sequencing Panel	Acute Myelogenous Leukemia Chronic Myeloid Leukemia Chronic Myelomonocytic Leukemia ...	Illumina	Research Use Only
TruSight Oncology 500 Assay	Bladder Cancer Breast Cancer Colon Cancer ...	Illumina	Research Use Only
TruSight Oncology 500 HRD Assay		Illumina	Research Use Only
TruSight Oncology 500 ctDNA v2	Solid Tumor	Illumina	Research Use Only
TruSight Oncology Comprehensive	Breast Cancer CNS Tumor Colorectal Cancer ...	Illumina
TruSight RNA Pan-Cancer Panel	Leukemia Lymphoma Solid Tumor	Illumina	Research Use Only
TruSight Tumor 15 Assay	Solid Tumor	Illumina	Research Use Only
TruSight Tumor 170 Assay	Solid Tumor	Illumina	Research Use Only
Trucheck™	Breast Cancer Colorectal Cancer Prostate Cancer	Datar Cancer Genetics	CE Marked
TrueMark™ MSI Assay	Solid Tumor	Thermo Fisher Scientific	Research Use Only
Tumor tissue origin gene detection kit	Solid Tumor	Canhelp Genomics	Other Approval
TumorNext-HRD	Ovarian Cancer	Tempus	Laboratory Developed Test
TumorNext-Lynch	Bladder Cancer Colorectal Cancer Endometrial Cancer ...	Tempus	Laboratory Developed Test
Tumour-Agnostic ctDNA MRD Assay	Non Small Cell Lung Cancer	Medicover Genetics	Laboratory Developed Test
U-TOP MSI detection kit	Biliary Tract Cancer Bladder Cancer Colorectal Cancer ...	Seasun Biomaterials	Laboratory Developed Test
UBC® Rapid	Bladder Cancer	IDL Diagnostics	Laboratory Developed Test
URO17™	Bladder Cancer	Protean BioDiagnostics	Laboratory Developed Test
UW-Oncoplex™	Leukemia Lung Cancer Melanoma ...	University of Washington	Laboratory Developed Test
Ultra-Sensitive Signatera™ Genome MRD Test	Breast Cancer Colorectal Cancer Melanoma ...	Natera	Laboratory Developed Test
UltraSEEK® Colon Panel	Colon Cancer	Agena Bio	Research Use Only
UltraSEEK® Lung Panel	Non Small Cell Lung Cancer	Agena Bio	Research Use Only
UltraSEEK® Melanoma Panel	Melanoma	Agena Bio	Research Use Only
UriFind® Methylation Test	Bladder Cancer Urothelial Cancer	AnchorDx	CE Marked
UroAmp	Bladder Cancer Urothelial Cancer	Convergent Genomics	Laboratory Developed Test
UroSEEK	Bladder Cancer	Sidney Kimmel Comprehensive Cancer Center	Laboratory Developed Test
UroVysion™ Bladder Cancer Kit (UroVysion Kit)	Bladder Cancer	Abbott	FDA Approved (PMA)
Urodiag®	Bladder Cancer	OncoDiag	CE-IVD (Old IVDD)
Uromonitor®	Bladder Cancer	Ipatimup	CE Marked
VENTANA ALK (D5F3) CDx Assay	Non Small Cell Lung Cancer	Roche	FDA Approved (PMA)
VENTANA CLDN18 (43-14A) Assay	Gastric Adenocarcinoma Gastroesophageal Junction Adenocarcinoma	Roche
VENTANA DLL3 (SP347) Assay	Small Cell Lung Cancer	Roche	Laboratory Developed Test
VENTANA FOLR1 RxDx Assay	Fallopian Tube Cancer Ovarian Cancer Peritoneal Cancer	Roche	FDA Approved (PMA)
VENTANA HER2 Dual ISH DNA Probe Cocktail	Breast Cancer	Roche
VENTANA MSLN (SP74) ASSAY	Solid Tumor	Roche	Laboratory Developed Test
VENTANA PD-L1 (SP142) Assay	Non Small Cell Lung Cancer Triple Negative Breast Cancer Urothelial Cancer	Roche
VENTANA PD-L1 (SP263) Assay	Non Small Cell Lung Cancer Urothelial Cancer	Roche
VENTANA ROS1 (SP384) Rabbit Monoclonal Primary Antibody	Lung Adenocarcinoma Non Small Cell Lung Cancer	Roche	Laboratory Developed Test
VENTANA anti-BRAF V600E (VE1) Mouse Monoclonal Primary Antibody	Colorectal Cancer	Roche
VENTANA anti-E-cadherin (36) Mouse Monoclonal Primary Antibody	Breast Cancer	Roche	Laboratory Developed Test
VENTANA anti-MLH-1 (M1) Mouse Monoclonal Primary Antibody	Colorectal Cancer	Roche	FDA Approved (PMA)
VENTANA anti-MSH2 (G219-1129) Mouse Monoclonal Primary Antibody	Colorectal Cancer	Roche	FDA Approved (PMA)
VENTANA anti-MSH6 (SP93) Rabbit Monoclonal Primary Antibody	Colorectal Cancer	Roche	FDA Approved (PMA)
VENTANA anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody	Colorectal Cancer	Roche	FDA Authorized (EUA/De Novo)
VENTANA pan-TRK (EPR17341) Assay	Non Small Cell Lung Cancer Solid Tumor	Roche	CE-IVD (Old IVDD)
VENTANA® Kappa and Lambda Dual ISH mRNA Probe Cocktail Assay	Non-Hodgkin’s Lymphoma	Roche	CE Marked
VENTANA® MET (SP44) RxDx Assay	Non Small Cell Lung Cancer	Roche	FDA Approved (PMA)
VENTANA® TROP2 (EPR20043) RxDx Assay	Non Small Cell Lung Cancer	Roche	Laboratory Developed Test
VHIO-Card-300-v4 panel	Ovarian Cancer	Vall d'Hebron Institute of Oncology	Laboratory Developed Test
VarMap™ Pan-Cancer NGS Panel	Leukemia Lymphoma Solid Tumor	NuProbe	Laboratory Developed Test
VarTrace® MSI Assay	Endometrial Cancer	NuProbe	Research Use Only
Vartrace® AML Panel	Acute Myelogenous Leukemia	NuProbe	Laboratory Developed Test
Vartrace® BRAF Panel	Colorectal Cancer Melanoma Thyroid Gland Papillary Carcinoma	NuProbe	Laboratory Developed Test
Vartrace® EGFR Panel	Non Small Cell Lung Cancer	NuProbe	Laboratory Developed Test
Velox™	Breast Cancer Colorectal Cancer Kidney Cancer ...	Thermo Fisher Scientific	Laboratory Developed Test
Ventana CONFIRM anti-CD8 (SP57) Rabbit Monoclonal Primary Antibody	Lymphoma	Roche	Laboratory Developed Test
Ventana MMR RxDx Panel	Endometrial Cancer Solid Tumor	Roche	FDA Approved (PMA)
VeriStrat®	Non Small Cell Lung Cancer	Biodesix	Laboratory Developed Test
Videssa® Breast	Breast Cancer	Todos Medical	Laboratory Developed Test
VisioCyt®	Bladder Cancer	Atlanpole Biotherapies	CE Marked
Vysis ALK Break Apart FISH Probe Kit	Non Small Cell Lung Cancer	Abbott
Vysis CLL FISH Probe Kit	Chronic Lymphocytic Leukemia	Abbott	FDA Approved (PMA)
Vysis D7S486/CEP 7 FISH Probe Kit	Acute Myelogenous Leukemia Myelodysplastic Syndrome	Abbott	FDA Cleared (510k)
Vysis EGR1 FISH Probe Kit	Acute Myelogenous Leukemia	Abbott	FDA Cleared (510k)
Vysis ROS1 Break Apart FISH Probe Kit	Colorectal Cancer Gastric Adenocarcinoma Melanoma ...	Abbott	CE Marked
Xerna TME™ Panel		Qiagen	Laboratory Developed Test
Xpert HPV Assay	Cervical Cancer	Danaher Corp	CE-IVD (Old IVDD)
Xpert® BCR-ABL Ultra	Chronic Myeloid Leukemia	Danaher Corp	FDA Cleared (510k)
Xpert® Bladder Cancer Monitor	Bladder Cancer	Danaher Corp	CE-IVD (Old IVDD)
Xpert® Breast Cancer STRAT4	Breast Cancer	Danaher Corp	CE-IVD (Old IVDD)
Xpert® NPM1 Mutation assay	Acute Myelogenous Leukemia	Danaher Corp	CE-IVD (Old IVDD)
ZytoLight® SPEC 11q gain/loss Triple Color Probe	Lymphoma	ArchiMed	CE-IVD (Old IVDD)
ZytoLight® SPEC ALK Dual Color Break Apart Probe	Non Small Cell Lung Cancer	ArchiMed	CE-IVD (Old IVDD)
ZytoLight® SPEC BCOR Dual Color Break Apart Probe	Ewing Sarcoma Lymphoma	ArchiMed	CE-IVD (Old IVDD)
ZytoLight® SPEC ERBB2/CEN 17 Dual Color Probe Kit	Breast Cancer	ArchiMed	CE-IVD (Old IVDD)
ZytoLight® SPEC MYB Dual Color Break Apart Probe	Adenoid Cystic Carcinoma	ArchiMed	CE-IVD (Old IVDD)
ZytoLight® SPEC ROS1 Dual Color Break Apart Probe	Non Small Cell Lung Cancer	ArchiMed	CE-IVD (Old IVDD)
clonoSEQ	Acute Lymphocytic Leukemia Chronic Lymphocytic Leukemia Diffuse Large B Cell Lymphoma ...	Adaptive Biotech
cobas® 4800 BRAF V600 Mutation Test	Melanoma Thyroid Gland Papillary Carcinoma	Roche	FDA Approved (PMA)
cobas® EGFR Mutation Test v2	Non Small Cell Lung Cancer	Roche
cobas® EZH2 Mutation Test	Follicular Lymphoma	Roche	FDA Approved (PMA)
cobas® HPV test	Cervical Cancer	Roche	FDA Approved (PMA)
cobas® KRAS Mutation Test	Colorectal Cancer	Roche	FDA Approved (PMA)
cobas® PIK3CA Mutation Test	Breast Cancer	Roche	CE Marked
ctDNA EGFR Mutation Detection Kit	Lung Cancer	EntroGen	CE-IVD (Old IVDD)
ctDNAaccuPanel™ Lung	Lung Cancer	NGeneBio	Laboratory Developed Test
dPCR CNV Probe Assays	Sarcoma Thyroid Gland Carcinoma	Qiagen	Laboratory Developed Test
dPCR LNA Mutation Assays	Sarcoma Thyroid Gland Carcinoma	Qiagen	Laboratory Developed Test
ddPLEX ESR1 Mutation Detection Kit	Breast Cancer	Bio-Rad	Research Use Only
epiHERA™	Endometrial Cancer	INEX Innovate	Laboratory Developed Test
gen-TRU-breast™ Assay	Breast Cancer	IV BioHoldings	Laboratory Developed Test
geneType Breast Cancer Risk Assessment Test	Breast Cancer	Rhythm Pharma	Laboratory Developed Test
geneType Prostate Cancer Risk Assessment Test	Prostate Cancer	Rhythm Pharma	Laboratory Developed Test
iPLEX® HS Lung Panel	Non Small Cell Lung Cancer	Agena Bio	Research Use Only
ipsogen BCR-ABL1 mbcr Kit	Acute Lymphocytic Leukemia	Qiagen	Research Use Only
ipsogen JAK2 MutaScreen Kit	Myeloproliferative Neoplasm	Qiagen	Research Use Only
miLung	Non Small Cell Lung Cancer	Hummingbird Diagnostics	Laboratory Developed Test
miRisk	Non Small Cell Lung Cancer	Hummingbird Diagnostics	Laboratory Developed Test
myPath Melanoma	Melanoma	Castle Biosci	Laboratory Developed Test
nCounter® Breast Cancer 360™ Panel	Breast Cancer	NanoString Technologies	Research Use Only
nCounter® CAR-T Characterization Panel		NanoString Technologies	Research Use Only
nCounter® Immune Exhaustion Panel		NanoString Technologies	Research Use Only
nCounter® Metabolic Pathways Panel		NanoString Technologies	Research Use Only
nCounter® PanCancer IO 360™ Panel	Leukemia Lymphoma Solid Tumor	NanoString Technologies	Research Use Only
nCounter® PanCancer Immune Profiling Panel	Breast Cancer Colon Cancer Ovarian Cancer	NanoString Technologies	Research Use Only
nCounter® PanCancer Pathways Panel	Breast Cancer	NanoString Technologies	Research Use Only
nCounter® PanCancer Progression Panel	Lung Cancer Prostate Cancer	NanoString Technologies	Research Use Only
nCounter® Tumor Signaling 360 Panel		NanoString Technologies	Research Use Only
nCounter® miRNA Expression Assay Kit		NanoString Technologies	Research Use Only
oncoReveal™ 4-Gene Methylation Panel	Breast Cancer	Pillar Biosci	Research Use Only
oncoReveal™ Core LBx	Solid Tumor	Pillar Biosci	Laboratory Developed Test
oncoReveal™ Dx Colon Cancer Assay	Colorectal Cancer	Pillar Biosci	Other Approval
oncoReveal™ Essential LBx	Solid Tumor	Pillar Biosci	Research Use Only
oncoReveal™ Fusion LBx Panel	Solid Tumor	Pillar Biosci	Research Use Only
oncoReveal™ Multi-Cancer with CNV & RNA Fusion Panel		Pillar Biosci	Research Use Only
oncoReveal™ Nexus	Hematological Malignancies Solid Tumor	Pillar Biosci	Research Use Only
oncoReveal™ Solid Tumor v2 Panel	Bladder Cancer Colorectal Cancer Endometrial Cancer ...	Pillar Biosci	Research Use Only
pstateDx™ test	Prostate Cancer	BPGbio	Laboratory Developed Test
therascreen PDGFRA RGQ PCR kit	Gastrointestinal Stromal Tumor	Qiagen	FDA Approved (PMA)
therascreen® BRAF V600E RGQ PCR	Colorectal Cancer	Qiagen	FDA Approved (PMA)
therascreen® EGFR Plus RGQ PCR Kit	Non Small Cell Lung Cancer	Qiagen	CE Marked
therascreen® EGFR RGQ PCR Kit	Breast Cancer Non Small Cell Lung Cancer	Qiagen
therascreen® FGFR RGQ RT-PCR Kit	Urothelial Cancer	Qiagen	FDA Approved (PMA)
therascreen® KRAS RGQ PCR Kit	Colorectal Cancer Non Small Cell Lung Cancer	Qiagen	FDA Approved (PMA)
therascreen® PIK3CA RGQ PCR Kit	Breast Cancer	Qiagen	FDA Approved (PMA)