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Exact Sciences Announces Medicare Coverage for Oncodetect™ Molecular Residual Disease Test in Colorectal Cancer (Exact Sciences Press Release)
"Exact Sciences Corp...today announced that its Oncodetect™ molecular residual disease (MRD) test has received Medicare coverage through the Centers for Medicare & Medicaid Services’ (CMS) 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"
Clinical data
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OncodetectTM MRD Test
5ms
The promise of molecular residual disease (MRD) testing for patients with colorectal cancer. (PubMed, Clin Adv Hematol Oncol)
Multiple platforms are already in clinical use or being developed as part of research studies. One such platform using the Oncodetect MRD test has confirmed the value of ctDNA testing and its association with recurrence-free survival at multiple timepoints (postsurgical, post-definitive therapy, and surveillance) in patients with colorectal cancer.
Review • Journal
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CEACAM5 (CEA Cell Adhesion Molecule 5)
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OncodetectTM MRD Test
6ms
Exact Sciences Announces Expanded Clinical Validation of the Oncodetect™ Test and Molecular Residual Disease Innovation Roadmap (Exact Sciences Press Release)
"Exact Sciences Corp...today announced new data to be presented from the Beta-CORRECT clinical validation study at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. Results from Beta-CORRECT, a subset of the GALAXY cohort, validate the performance of its tumor-informed molecular residual disease (MRD) test, Oncodetect™, in predicting recurrence in stage II–IV colorectal cancer. These data confirm the test’s role in supporting treatment and surveillance decisions."
Clinical data
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OncodetectTM MRD Test
11ms
New Evidence Validates Oncodetect’s Ability to Detect Molecular Residual Disease and Predict Recurrence in Colorectal Cancer Patients (Businesswire)
"Exact Sciences...shared clinical validation data for its Oncodetect MRD test at the 2025...ASCO GI. Results from Alpha-CORRECT, a study with one of the longest MRD surveillance monitoring periods to date, showed the Oncodetect test achieved 78% sensitivity at the post-surgical timepoint and 91% sensitivity during the surveillance monitoring period, with specificities of 80% and 94%, respectively1. The complete findings of the study, which primarily included patients with stage III colon cancer, will be published in a peer-reviewed scientific journal on January 25....In addition to the data shared at ASCO GI, Oncodetect achieved its primary endpoint in the Beta-CORRECT study. Results confirm a significant association between MRD positivity and recurrence in patients with stage III colon cancer....Results will be presented at an upcoming scientific conference."
Observational data • Launch
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OncodetectTM MRD Test