- Exact Sciences Corp. (EXAS, Financial) secures Medicare coverage for Oncodetect™ MRD test.
- The test is applicable for stage II, III, and resectable stage IV colorectal cancer patients.
- Medicare coverage could impact over three million eligible patients with multiple solid tumors.
Exact Sciences Corp. (EXAS), a leader in cancer screening and diagnostics, has announced that its Oncodetect™ molecular residual disease (MRD) test has gained Medicare coverage. This approval comes from the Centers for Medicare & Medicaid Services’ (CMS) Molecular Diagnostic Services Program (MolDX) and applies to the test's serial use in patients with stage II, III, and resectable stage IV colorectal cancer (CRC) in both adjuvant and recurrence monitoring settings over a five-year period.
This Medicare coverage represents a significant advancement in improving early cancer detection and personalized care for more than three million Americans eligible for MRD testing across various solid tumors. The Oncodetect™ test offers oncologists and patients critical insights, identifying cancer recurrence up to two years earlier than traditional imaging techniques by tracking up to 200 circulating tumor DNA (ctDNA) variants.
Brian Baranick, Executive Vice President and General Manager, Precision Oncology at Exact Sciences, highlighted the clinical value of the Oncodetect™ test by saying, "Gaining Medicare coverage for the Oncodetect test is a meaningful step forward in expanding access to earlier, more personalized insights for patients with colorectal cancer." This move further reinforces Exact Sciences’ leadership in advancing oncology tools that facilitate timely and informed treatment decisions.
The Oncodetect™ test is backed by robust clinical validation studies, including Beta-CORRECT and Alpha-CORRECT, which confirm its prognostic power across CRC stages. By integrating with the ExactNexus™ technology platform, the test enables seamless ordering alongside other Exact Sciences solutions, offering a comprehensive approach to precision oncology.
Exact Sciences is also pursuing additional Medicare coverage for other solid tumor indications, intending to expand the benefits of MRD testing to a broader patient base.
