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A new blood test just changed colorectal cancer screening forever. 🩸
Everyone is celebrating this as a technology win. And it is. But the harder problem is not the test. It is the 60 million Americans who are already overdue for screening and still will not show up.
On July 27, 2026, the FDA approved SimpleScreen CRC, Freenome’s blood-based screening test for colorectal cancer in adults 45 and older at average risk. Abbott will exclusively commercialize it in the U.S. this fall.
Here is what the data actually shows, according to Freenome’s press release:
– The PREEMPT CRC study enrolled more than 48,000 asymptomatic, average-risk adults ages 45 to 85 across more than 200 sites. That is the largest prospective clinical validation study ever conducted for a blood-based CRC screening test.
– SimpleScreen CRC detected colorectal cancer with 81.1% sensitivity, meaning it correctly identified about 8 in 10 colorectal cancers.
– It showed 90.4% specificity for advanced colorectal neoplasia, correctly producing negative results for 9 of 10 people without colorectal cancer or advanced precancerous lesions.
– Sensitivity for advanced precancerous lesions was 13.7%, including 30.7% for those with high-grade dysplasia.
The tool is genuinely impressive. A simple blood draw, no prep, no procedure.
🔍 The gap this is trying to close is real. Colorectal cancer is the second-leading cause of cancer-related death in the U.S. The disease will claim more than 55,000 lives this year alone. And 90% of those deaths are preventable, according to Freenome’s press release.
Now three stakeholder lenses that matter right now:
For the patient: a blood draw at a routine visit removes the biggest barrier to colorectal cancer screening, which is the colonoscopy prep. For patients who have avoided screening entirely, this is a real on-ramp.
For the provider: a positive SimpleScreen CRC result still requires a diagnostic colonoscopy. That means any health system or FQHC deploying this test needs a clear follow-up pathway before the test ever gets ordered. If you cannot close the loop on a positive result, you have not closed the gap.
For the payer and health system: SimpleScreen CRC meets Medicare coverage criteria. That removes one major adoption barrier. But coverage is not the same as utilization. The infrastructure question, who calls the patient back, who navigates the follow-up colonoscopy, who documents completion, still falls to the health system.
📋 Save this framework. If you are a health system or FQHC administrator considering a blood-based CRC screening program, these are the three questions to answer before you launch:
1. Do you have a defined follow-up protocol for positive results that reaches the patient within a specific timeframe?
2. Who owns colonoscopy coordination for patients who test positive and do not self-navigate?
3. How will you track screening completion, not just test ordering, in your population health dashboard?
A screening test and a screening program are not the same thing. The former is now easier than ever. The latter still requires deliberate design.
Colorectal cancer screening does not fail because patients refuse. It fails because the system does not make the path clear and easy. This approval is a genuinely important tool. Whether it moves the number depends entirely on how health systems integrate it.
👉 Follow Jonathan Govette, CEO of Oatmeal Health, for daily healthcare insights on LinkedIn. Deeper dives in The Oatmeal Bite on Substack: https://news.oatmealhealth.com
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Author:
CEO/Co-Founder @ Oatmeal Health | AI Lung Cancer Screening | Almost Became a Doctor | Engineer | Follow to Share What I’ve Learned Along the Way
I help patients get the care they need earlier, preventing late-stage cancer.
That’s been the throughline across three companies and almost 20 years in healthcare. At ReferralMD, we fixed broken referral networks so patients didn’t fall through the cracks. At Oatmeal Health, it’s lung cancer: building the diagnostic and screening infrastructure so the 85% of cases caught too late get caught early instead.
Today as CEO of Oatmeal Health, I lead a team embedding AI into radiology workflows to turn routine lung CT scans into reimbursable cancer risk assessments. We partner with FQHCs to reach underserved communities, and with health systems and payers to make early detection economically sustainable. Think HeartFlow or Cleerly, but for lungs.
Between companies, I advised at Techstars and Plug and Play, mentoring founders building in digital health. That experience shaped how I think about what separates companies that ship from companies that stall: distribution, reimbursement, and clinical trust, not just technology.
I’m a CancerX alumnus, a 3x healthcare founder, and someone who believes the biggest problems in cancer aren’t scientific. They’re operational.
We’re hiring mission-driven builders at Oatmeal Health. If you want to work on something that matters, reach out.
When I’m not working, I’m traveling, mentoring, and keeping up with one very energetic husky. 🐾
Substack – The Oatmeal Bite:
Millions of patients get less care because of who they are, where they live, or how they look. I’m fighting to change that. CEO @OatmealHealth, a startup built for the underserved. The Oatmeal Bite: intel for clinicians, investors, and advocates.
Jonathan Govette
CEO of Oatmeal Health
Substack:
https://oatmealhealthjonathangovette.substack.com/
