Exact Sciences Corp. (Nasdaq: EXAS), a leader in cancer diagnostics, announced that its Oncodetect™ molecular residual disease (MRD) test has received Medicare coverage under the Centers for Medicare & Medicaid Services’ (CMS) Molecular Diagnostic Services Program (MolDX). The coverage applies to serial testing in patients with stage II, III, and resectable stage IV colorectal cancer (CRC) during adjuvant treatment and recurrence monitoring, over a five-year period.
This decision marks a major milestone for Exact Sciences in its mission to transform cancer care through earlier detection and more individualized treatment. The final Local Coverage Determination (LCD) and billing and coding article are now publicly available through CMS.
The Oncodetect assay is a highly sensitive, tumor-informed MRD test that analyzes up to 200 circulating tumor DNA (ctDNA) variants. It offers oncologists and patients critical, real-time insights throughout the course of treatment and has demonstrated the ability to detect recurrence up to two years earlier than standard imaging techniques.
“Medicare coverage for Oncodetect is a significant advancement in expanding access to personalized cancer monitoring for patients with colorectal cancer,” said Brian Baranick, Executive Vice President and General Manager of Precision Oncology at Exact Sciences. “This decision validates the clinical impact of our MRD technology and strengthens our position as a leader in precision oncology.”
The test’s utility is backed by extensive clinical research, including the Beta-CORRECT study—Exact Sciences’ largest MRD trial to date—which confirmed its prognostic capabilities across CRC stages II–IV. Additional long-term evidence comes from Alpha-CORRECT, one of the longest follow-up studies of MRD in CRC patients.
Integrated with the ExactNexus™ platform, Oncodetect allows for seamless test ordering alongside other precision oncology solutions offered by the company. Building on this momentum, Exact Sciences is also pursuing expanded Medicare coverage for MRD testing in other solid tumors, aiming to bring earlier and more precise care to a broader patient population.