Exact Sciences Corp., a leading provider of cancer screening and diagnostic tests, announced that its Oncodetect molecular residual disease test has received Medicare coverage through the Centers for Medicare & Medicaid Services’ Molecular Diagnostic Services Program (MolDX) for serial use in patients with stage II, III and resectable stage IV colorectal cancer (CRC) in the adjuvant and recurrence monitoring settings over a five-year period. The final LCD can be found here, and the billing and coding article here, from CMS. This marks a significant milestone in the company’s mission to transform cancer treatment through earlier detection and more personalized care.
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Exact Sciences’ Medicare coverage for its Oncodetect molecular residual disease (MRD) test in colorectal cancer marks a significant milestone in the company’s mission to transform cancer care through earlier detection and more personalized treatment.
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Medicare coverage for colorectal cancer is a step forward to address the more than three million Americans eligible for MRD testing across multiple solid tumors. The highly sensitive, tumor-informed assay empowers oncologists and patients with insights during critical moments throughout treatment. The Oncodetect test tracks up to 200 ctDNA variants and can identify signs of cancer recurrence up to two years earlier than imaging alone.2
“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,” said Brian Baranick, Executive Vice President and General Manager, Precision Oncology at Exact Sciences. “This decision underscores the clinical value of our MRD test and reinforces Exact Sciences’ leadership in advancing tools that support timely, informed treatment decisions.”
The Oncodetect test is supported by robust clinical validation studies, including Beta-CORRECT—Exact Sciences’ largest MRD clinical study to date—which confirms the test’s prognostic power across stages II-IV CRC, and Alpha-CORRECT, one of the longest-followed MRD cohorts for CRC recurrence. Its integration with the ExactNexus™ technology platform enables seamless ordering alongside other Exact Sciences Precision Oncology solutions. Exact Sciences is pursuing additional Medicare coverage across other solid tumor indications, building on this momentum to bring the benefits of MRD testing to more patients.
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Source – businesswire
