Exact Sciences Corp (Nasdaq: EXAS), cancer screening and diagnostic tests provider, announced on Wednesday that its Oncodetect molecular residual disease (MRD) test has received Medicare coverage under the Centers for Medicare & Medicaid Services' MolDX program. The decision applies to serial testing in patients with stage II, III, and resectable stage IV colorectal cancer in both adjuvant and recurrence monitoring settings, over a five-year period.
Designed to detect circulating tumor DNA (ctDNA), the tumor-informed assay tracks up to 200 variants and can identify cancer recurrence up to two years earlier than imaging. Oncodetect is integrated with the ExactNexus™ platform for streamlined ordering across Exact Sciences' Precision Oncology portfolio.
Backed by clinical validation studies, including the Beta-CORRECT and Alpha-CORRECT trials, Oncodetect has demonstrated strong prognostic capabilities across CRC stages. The test provides a quantitative assessment of MRD, aiding in personalised treatment planning.
This milestone advances Exact Sciences' strategy to broaden MRD access and underscores its leadership in cancer diagnostics. Additional Medicare coverage for other solid tumor indications is being pursued.
Exact Sciences' broader portfolio includes established products such as Cologuard and Oncotype DX, supporting informed decision-making throughout the cancer care continuum.
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Astrazeneca Imfinzi perioperative regimen gains positive EU CHMP opinion in early gastric cancer
I Peace generates human iPS cells from NKT cells and offers them for research use
Frontage expands early phase clinical research capabilities across US and China
Summit Therapeutics' BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA
InSysBio agrees new collaborative project with BeOne Medicines
Physiomics secures new modelling contract with Numab Therapeutics
Mabwell reports first patient dosed with 7MW4911 in US trial
Atossa Therapeutics' founder and CEO named one of The Top 50 Healthcare Technology CEOs of 2025
Avacta secures FDA clearance for second pre|CISION oncology programme
Guardant Health and Merck enter multi-year oncology diagnostics collaboration
Akeso secures NMPA review acceptance for gumokimab in ankylosing spondylitis