A few weeks ago, at ASCO, Exact Sciences published new validation data on its Oncodetect MRD test (here). July 9, 2025, press release that they'ave acheived MolDx coverage for Oncodetect in colorectal cancer (here).
They key paragraph is here:
- Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, 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.
- The final LCD can be found here, and the billing and coding article here, from CMS. [see original press release link].
- This marks a significant milestone in the company’s mission to transform cancer treatment through earlier detection and more personalized care.
See the Oncodetect webpages:
https://www.exactsciences.com/cancer-testing/oncodetect-mrd-providers
Share price was up 2% to $55; market cap about $10B.
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Nerd Note - Billing geography. Last time I checked, Exact billed its Oncotype test to Medicare from Wisconsin, and its Genomic Health tests from California. MolDx coverage policies don't apply in Wisconsin, so Exact would likely bill Oncodetect from California to get the MolDx coverage. That was my first guess. However, the "Facility" tab at the DEX database (next section) says Genomic Health, Phoenix AZ.
Fine print on the press release says, Oncodetect is a trademark of Genomic Health Inc - otherwise, "Genomic Health" is pretty absent from the press release. They note that Oncodetect was "developed by Exact Sciences."
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Nerd Note - DEX App. MolDx has a web app, DEX, for coverage. Oncodetect Single Plasma Test is listed today at $1158. Plasma Series is $3177. Bespoke Assay Design and Single Plasma Test is $3878. "Locale" = Genomic Health, Phoenix, AZ. The DEX app also lists the OncoExTra exome test as based in AZ.
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Amal Thommil of Decibio periodically updates his map of MoLDx coverage for MRD applications. Find one from January 2025 here:
