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TEST:
LymphoTrack® Dx IGH Assay

Type:
Laboratory Developed Test
Related tests:
Evidence

News

10ms
Comparative analysis of a novel next-generation sequencing-based IGH clonality assay for measurable residual disease detection in pediatric B-cell acute lymphoblastic leukemia patients. (PubMed, Pediatr Hematol Oncol)
The correlation coefficients (r) of MRD levels were 0.831 between CM-IGH and LT-IGH, 0.702 between CM-IGH and MFC, and 0.776 between LT-IGH and MFC. The CM-IGH assay demonstrates substantial concordance with LT-IGH and MFC in detecting MRD in pediatric patients with B-ALL, highlighting the complementary value of IGH clonality assays and MFC.
Journal • Next-generation sequencing
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LymphoTrack® Dx IGH Assay
12ms
Detection of MRD Using IGH Assay By NGS after Second Cycle of Chemotherapy in Adult B-Lymphoblastic Leukemia Predicts Poor Clinical Outcomes: Results from a Multicenter Study (ASH 2024)
All patients with Philadelphia chromosomes-positive ALL received imatinib concomitantly with chemotherapy...Detection of IgH clonality after second cycle of chemotherapy correlates with inferior survival in B-ALL. Therefore, those patients should be considered for subsequent treatments, such as allogeneic stem cell transplantation or novel monoclonal antibody.
Clinical • Clinical data • Next-generation sequencing
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LymphoTrack® Dx IGH Assay
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imatinib
1year
Pivotal, Clinical Study for the Accuracy Evaluation of the IdentiClone Dx IGH Assay (clinicaltrials.gov)
P=N/A, N=250, Completed, Invivoscribe, Inc. | Recruiting --> Completed | Trial completion date: Aug 2024 --> Nov 2024 | Trial primary completion date: Jun 2024 --> Nov 2024
Trial completion • Trial completion date • Trial primary completion date
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LymphoTrack® Dx IGH Assay
1year
IGHV (Immunoglobulin Heavy Chain Variable-Region) Gene Mutational Status Validation and Subsequent First-Year Experience (AMP 2024)
Based on our experience, SHM status can be achieved by routine NGS testing. Our first-year mutated-versus-unmutated test results are reasonably close to what is reported in the literature, supporting the effectiveness of this assay. The majority (66.6%) of QNS samples were due to lack of evidence of clonality in CLL samples.
IGH (Immunoglobulin Heavy Locus)
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IGH mutation
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LymphoTrack® Dx IGH Assay
1year
Measurable Residual Disease Monitoring for Philadelphia Positive Acute Lymphoblastic Leukemia (Ph+ALL) in the Setting of the Gimema ALL2820 Trial (ASH 2024)
Samples derived from cases from both the experimental and the control arm, based respectively on ponatinib followed by blinatumomab and on a combination of imatinib and conventional chemotherapy. While some groups reported a higher predictive prognostic power of IG/TR monitoring, our findings do not confirm these data, also in view of the very low rate of relapses so far observed. Nevertheless, a double-hit strategy may be informative for MRD monitoring and possibly for the distinction between typical/lymphoid Ph+ ALL vs multilineage/CML-like Ph+ ALL.
IO biomarker
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ABL1 (ABL proto-oncogene 1) • IKZF1 (IKAROS Family Zinc Finger 1)
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ABL1 fusion
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LymphoTrack® Dx IGH Assay • LymphoTrack® Dx IGK Assay
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imatinib • Iclusig (ponatinib) • Blincyto (blinatumomab)
1year
Measurable Residual Disease in Adult B Lymphoblastic Leukemia: A Study of Concordance between Multiparametric Flow Cytometry, Next-Generation Sequencing of Immunoglobulin Gene Rearrangements, and Quantitative PCR (ASH 2024)
Method : This study involved adult patients aged 19 or older with B-ALL, treated with modified hyper-CVAD (hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone) and allogeneic hematopoietic stem cell transplant (allogeneic-HSCT) at Catholic Hematology Hospital from May 2022 to June 2024...Poor MRD response was defined as > 0.1%, and complete MRD response as < 0.001%, and poor MRD responders were treated with MRD-directed therapy using blinatumomab or next-generation tyrosine kinase inhibitors...Conclusion : Our data suggested all MRD detection methods showed acceptable power and good concordance rates, but the detection power was different between Ph-positive and Ph-negative ALL. We also suggested MRD-directed therapeutic strategies might predict the significant time point of MRD for the prediction of survival outcomes.
Clinical • Next-generation sequencing • Discordant
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ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase) • CD73 (5'-Nucleotidase Ecto) • CD123 (Interleukin 3 Receptor Subunit Alpha) • CD22 (CD22 Molecule) • CEACAM6 (CEA Cell Adhesion Molecule 6) • IL3RA (Interleukin 3 Receptor Subunit Alpha) • NRP1 (Neuropilin 1)
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LymphoTrack® Dx IGH Assay
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doxorubicin hydrochloride • cyclophosphamide • Blincyto (blinatumomab) • vincristine
1year
Clinical
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TP53 (Tumor protein P53) • WT1 (WT1 Transcription Factor) • CD36 (thrombospondin receptor) • EP300 (E1A binding protein p300) • XIAP (X-Linked Inhibitor Of Apoptosis) • CDKN2C (Cyclin Dependent Kinase Inhibitor 2C)
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WT1 mutation
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Archer® FusionPlex® Acute Lymphoblastic Leukemia (ALL) • FusionPlex® Dx • LymphoTrack® Dx IGH Assay
over1year
Genetic Markers of Chronic Lymp hocytic Leukemia: Mutational Landscape, and Subtypes in a Co hort of Lebanese Patients (AMP Europe 2024)
This study constitutes the first attempt at using NGS to assess the mutational status of the IGHV gene in Lebanese patients. Further investigation could help identify new subsets and classifications. Additional studies combining cytogenetic analysis and molecular testing may prove useful for a better understanding of the characteristics of CLL patients, leading to optimal personalized care.
Clinical
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IGH (Immunoglobulin Heavy Locus)
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LymphoTrack® Dx IGH Assay
over1year
SKY92 MOLECULAR PROFILING IN COMBINATION WITH MRD BY NGS TO IDENTIFY HIGH-RISK MULTIPLE MYELOMA PATIENTS IN IRELAND (MM-PIRE) (EHA 2024)
This is the largest study conducted to date in Ireland, profiling risk status in this genetically homogenousnorthern European population. In this study almost one third of TE-MM patients in Ireland present with HRdisease as defined by MMProfilerâ„¢ and validated by independent FISH. The reasons for the high prevalence ofHR-MM at diagnosis is not clear and further in-depth genomic profiling is needed.
Combination therapy • Clinical • Next-generation sequencing
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SDC1 (Syndecan 1)
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LymphoTrack® Dx IGH Assay
over1year
Evaluation of next-generation sequencing versus next-generation flow cytometry for minimal-residual-disease detection in Chinese patients with multiple myeloma. (PubMed, Discov Oncol)
"Compared with NGF, NGS exhibits higher sensitivity and reproducibility in MRD detection and can be an effective strategy for MRD monitoring in Chinese MM patients."
Journal • Minimal residual disease
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IGH (Immunoglobulin Heavy Locus)
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LymphoTrack® Dx IGH Assay
almost2years
Pivotal, Clinical Study for the Accuracy Evaluation of the IdentiClone Dx IGH Assay (clinicaltrials.gov)
P=N/A, N=250, Recruiting, Invivoscribe, Inc. | Not yet recruiting --> Recruiting
Enrollment open
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LymphoTrack® Dx IGH Assay
almost2years
SKY92 Molecular Profiling in Combination With MRD Risk Profiling to Identify High-Risk Multiple Myeloma Patients in Ireland (SKIP-MM) (EACR-AACR 2024)
We continue to evaluate the clinical significance of SKY92 in combination with MRD testing as a superior prognostic repertoire of testing. These methods will improve risk stratification, and in future aid with risk-adapted therapy approaches.
Combination therapy • Clinical
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Chr t(4;14)
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LymphoTrack® Dx IGH Assay