A stool-DNA test from Geneoscopy, ColoSense, was FDA approved in May 2024 (PMA P230001).
CMS covers the revised Cologuard test under the original 2014 NCD for Cologuard, but CMS couldn't stretch that NCD wide enough to include ColoSense. On September 10, 2025, CMS officially reopened the NCD, which will now be "Screening for Colorectal Cancer - Non-invasive Biomarker Tests."
The NCD 210.3 is currently titled "Colorectal cancer screening tests" and includes Cologuard, FOBT, and blood-based biomarker tests (screening LBx, Guardant). Current document found here.
The time couse is slow: Opening September 10, public comment September to October 10, and a proposed preliminary memo on March 10, 2026. CMS anticipates completion of the final memo by June 8, 2026, which is 25 months after the FDA approval date of the product.
Find the home page for the policy revision here:
https://www.cms.gov/medicare-coverage-database/view/ncacal-tracking-sheet.aspx?ncaid=319
Read the Geneoscopy request letter here. The request letter was submitted May 2024, about 16 months ago. (And submitted a week after the FDA approval).
https://www.cms.gov/files/document/id319.pdf
The request letter runs 12 pages.
Geneoscopy raised $105M in growth capital in January 2025.
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AI CORNER
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AI summary by Chat GPT 5.
TL;DR for Experts – Geneoscopy NCD Reconsideration Request (ColoSense™)
Clear Request:
Geneoscopy asks CMS to reopen and update NCD 210.3 (Colorectal Cancer Screening – Stool DNA Testing) to include stool RNA (sRNA) tests like its FDA-approved ColoSense™. They propose category-wide coverage language—not just for Cologuard—so any FDA-approved sRNA test with comparable sensitivity/specificity would be covered once every three years for average-risk beneficiaries aged 45–85.
Key Rationale:
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Regulatory Trigger: ColoSense received FDA PMA approval on May 3, 2024 (with Breakthrough Device designation since 2020).
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Clinical Validation: The pivotal CRC-PREVENT trial (n=8,920) showed 93–94% sensitivity for CRC (100% for Stage I) and performance metrics comparable to Cologuard’s 2014 data.
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Public Health Need: Adds a second FDA-cleared, non-invasive, at-home stool-based CRC screen—critical to recovering missed screenings from COVID-19 and advancing Cancer Moonshot goals.
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Policy Consistency: CMS has shifted toward category-based coverage (e.g., blood-based CRC screening tests in 2021, NGS in 2020); current sDNA-only language is outdated and forces one-off reconsiderations.
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Extra - Chat GPT 5 rates the likely next steps.
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ColoSense got an updated collection device in July 2025.
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Geneoscopy and Exact Sciences spent several years in patent litigation.
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Generally, CMS covers screening tests under direct instructions from Congress or after endorsement by USPSTF. However, statute allows CMS to create new screening benefits for colorectal cancer and prostate cancer by NCD, as occured for Cologuard in 2014 and as is occurring for ColoSense in 2026.
