COMPANY:

Interpace Biosci

"Interpace Diagnostics®...today announced that the Genetic Testing for Oncology (L39365) Local Coverage Determination (LCD) issued by the Medicare Administrative Contractor Novitas Solutions will go into effect, ending reimbursement for their PancraGEN® test. The Centers for Medicare & Medicaid Services (CMS) delayed implementation by 60 days earlier in the year and confirmed finalization of the LCD as of today, April 24, 2025."

"Interpace Diagnostics®…today announced notification that the Centers for Medicare & Medicaid Services (CMS) directed its Medicare Administrative Contractors, Novitas and First Coast Service Options, Inc., to delay implementation of the Genetic Testing for Oncology Local Coverage Determination (LCD) (L39365), from February 23, 2025, to April 24, 2025...This change of effective date will allow the incoming Trump administration time to fully review the proposed policy changes, re-evaluate for themselves the supporting clinical evidence for the PancraGEN® assay, and fully assess the negative impact on patient care if the currently proposed LCD comes into effect."

"Interpace Diagnostics®, a subsidiary of Interpace Biosciences...today responded to the final Local Coverage Determination (LCD) of Genetic Testing for Oncology (L39365) issued by the Centers for Medicare & Medicaid Services (CMS). The new LCD establishes non-coverage for the Company’s widely used PancraGEN® test."

"Interpace Diagnostics, a subsidiary of Interpace Biosciences...responded to the undefined extension granted by Centers for Medicare & Medicaid Services (CMS) to Novitas, its Medicare Administrative Contractor (MAC). Novitas announced late last week that CMS granted an extension to the final decision for Local Coverage Determination (LCD) of Genetic Testing for Oncology (L39365) in order for all comments received in response to the proposed changes to be thoroughly considered."

"Interpace Diagnostics...is proud to announce that new data demonstrating the application of advanced sequencing technologies in pancreatic cancer was published as an e-abstract as part of the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting."

"On July 6, 2023, Novitas Solutions, Inc. announced that it was rescinding implementation of the Genetic Testing for Oncology LCD (L39365) so that it will not become effective on July 17, 2023. As a result, Interpace is able to continue offering PancraGEN..."

"Interpace Biosciences, Inc...announced that the Centers for Medicare & Medicaid Services (CMS) issued the final Local Coverage Determination (LCD) of Genetic Testing for Oncology (L39365) which establishes non-coverage for the Company’s widely used PancraGEN® test effective July 17, 2023. Commercially available in its current form since 2013, PancraGEN is a DNA-based molecular diagnostic test that uniquely assesses the risk of pancreatic cancer posed by pancreatic cysts and is used to rule-in and rule-out (risk-stratify) the disease."

"Interpace Biosciences, Inc...announced new real-world clinical utility data for their ThyGeNEXT® + ThyraMIR®v2 combination test platform to assess the malignancy risk of indeterminate thyroid nodules (ITN). The findings are from an independent study and were shared today in a highlighted poster presentation during the American Thyroid Association (ATA) 2022 Annual Meeting (Poster #119)."

"Interpace Biosciences, Inc...announced new clinical validation data for their thyroid cancer test platform which is comprised of a mutation panel (ThyGeNEXT®) and a microRNA (miRNA) risk classifier. The new data demonstrates that the addition of miRNA pairwise expression profiling (ThyraMIR®v2) provides clinically and statistically superior risk stratification of indeterminate thyroid nodules (ITN) beyond that of the algorithmic classification analysis provided by the original ThyraMIR® assay."

"Interpace Biosciences, Inc...has announced that in association with Miroculus, Inc...it will optimize next generation sequencing (NGS) library preparation utilizing its digital microfluidics (DMF) technology. Also working in conjunction with Miroculus and Interpace Biosciences will be Twist Bioscience Corporation...Interpace Diagnostics will utilize Twist Bioscience’s chemistries for library preparation and hybridization capture for the automation of Interpace’s custom NGS panels, and Miroculus’s DMF instrument, the Miro Canvas, to enable low volume, accurate, and precise sample preparation for its genetic tests targeting specific markers in Endocrine and GI cancers."

"Interpace Biosciences, Inc...announced today that the National Correct Coding Initiative (NCCI) program issued a response on behalf of the Centers for Medicare & Medicaid Services (CMS) stating that the previously announced billing policy reimbursement for its ThyGeNEXT (O245U) and ThyraMIR (oo18U) tests, disclosed by it in a press release dated January 28, 2022, has been changed retroactive to January 1, 2022. As a result, the Company will continue billing for both tests according to its Laboratory Coverage Determination (LCD) as originally set by Novitas."

"Interpace...announced that it just became aware that the Centers for Medicare & Medicaid Services (CMS) issued a new billing policy whereby CMS will no longer reimburse for the use of the Company’s ThyGeNEXT® and ThyraMIR® tests when billed together by the same provider/supplier for the same beneficiary on the same date of service."