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FDA approves second blood-based colorectal cancer screening test

Freenome's SimpleScreen CRC detected roughly 8 in 10 cancers in the PREEMPT CRC trial — but just 13.7% of advanced precancerous lesions, the performance gap that keeps blood tests out of guideline-preferred status.

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The Food and Drug Administration has approved SimpleScreen CRC, a cell-free DNA blood test for colorectal cancer screening in average-risk adults aged 45 years and older, making it the second blood-based test cleared for the indication after Guardant Health's Shield in 2024.

The agency's decision on the premarket approval application is dated July 24, 2026.1 Freenome, which developed the test, and Abbott, which holds exclusive U.S. commercialization rights, announced the approval July 27.2 Abbott expects to launch the test this fall.

Under the approved labeling, SimpleScreen CRC is indicated for average-risk adults aged 45 years and older who have been referred for screening by a health care professional. A positive result should be followed by colonoscopy. The FDA approval order states explicitly that the test is not a replacement for diagnostic colonoscopy or for surveillance colonoscopy in high-risk individuals.1

What the pivotal data show

Approval rests on PREEMPT CRC, a prospective, multicenter study that enrolled 48,995 asymptomatic, average-risk adults aged 45-85 years at more than 200 U.S. sites, all of whom were scheduled for screening colonoscopy. In the evaluable cohort of 27,010 participants, the test detected colorectal cancer with 79.2% sensitivity and showed 91.5% specificity for advanced colorectal neoplasia, using colonoscopy with histopathology as the reference standard. Sensitivity for advanced precancerous lesions (APLs), a secondary endpoint, was substantially lower. Results were published online in JAMA in June 2025.3

The figures cited in the approval announcement come from a prespecified analysis weighted to the U.S. Census age and sex distribution: 81.1% sensitivity for colorectal cancer, 13.7% sensitivity for APLs, including 30.7% for APLs with high-grade dysplasia, and 90.4% specificity for advanced colorectal neoplasia.2

Guidelines still rank blood tests last

AGA has urged caution as the menu of screening options expands. In a statement issued in June, the association said colonoscopy remains the strongest option because it is the only test that can both catch cancer early and prevent it, since precancerous polyps can be removed during the same procedure. AGA called stool-based testing a reasonable alternative when colonoscopy is not available or feasible, provided patients understand that an abnormal result requires follow-up colonoscopy and that testing must be repeated at recommended intervals. Blood tests, the association said, should be approached with caution.4 The statement directs clinicians to AGA's 2025 clinical practice update in Clinical Gastroenterology and Hepatology on the current role of blood tests in screening.5

The American Cancer Society's 2026 screening guideline update, published in May in CA: A Cancer Journal for Clinicians, added blood-based testing as a recommended but explicitly nonpreferred category, advising it only for patients who decline or do not complete a stool-based test or visual examination. The guideline development group cited lower sensitivity for APLs and stage I cancers — noting that confidence intervals around the stage I estimate are wide — and uncertainty about optimal screening intervals.6

ASGE reached a similar position. In its position statement on blood-based screening, the society said simulation models project higher colorectal cancer incidence and mortality if patients shift to blood tests from colonoscopy or stool-based testing, an effect it attributed mainly to the low sensitivity of blood tests for APLs.7

Freenome said the test meets Medicare coverage criteria with approval, and that it expects SimpleScreen CRC to be added to the ACS guideline by name.2 The May guideline named only Shield among blood tests, as SimpleScreen CRC was still under FDA review at publication.6

A next-generation assay is on the way

The PMA covers the first-generation assay Freenome submitted in August 2025.1

On July 9, the company reported top-line results for an updated version that improved APL sensitivity to 18.2% and high-grade dysplasia sensitivity to 41.9%, with 80.4% sensitivity for colorectal cancer at 90% specificity. Freenome's modeling projected that those gains would yield 7.7% more life-years gained and 9.5% fewer colorectal cancer cases and deaths per 100,000 people screened, compared with the first-generation test.8 That version requires a supplemental PMA and is not yet approved.

References

  1. US Food and Drug Administration. SimpleScreen CRC — P250029. Premarket approval database. Decision date July 24, 2026. Accessed August 10, 2026. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250029

  2. FDA approves Freenome's SimpleScreen CRC blood-based screening test; Abbott to commercialize in the U.S. News release. Freenome, Inc., and Abbott; July 27, 2026. Accessed August 10, 2026. https://www.freenome.com/newsroom/fda-approves-freenomes-simplescreen-crc/

  3. Shaukat A, Burke CA, Chan AT, et al; PREEMPT CRC Investigators. Clinical validation of a circulating tumor DNA-based blood test to screen for colorectal cancer. JAMA. 2025;334(1):56-63. doi:10.1001/jama.2025.7515

  4. American Gastroenterological Association. Colonoscopy remains the top choice for colorectal cancer screening amid new guidance. June 18, 2026. Accessed August 10, 2026. https://gastro.org/news/colonoscopy-remains-the-top-choice-for-colorectal-cancer-screening-amid-new-guidance/

  5. Shaukat A, Ladabaum U, Kanth P, Lieberman D. AGA clinical practice update on current role of blood tests for colorectal cancer screening: commentary. Clin Gastroenterol Hepatol. 2025;23(9):1486-1491. doi:10.1016/j.cgh.2025.04.003

  6. Wolf AMD, Hoffman RM, Walter LC, et al. Colorectal cancer screening: an update to the American Cancer Society guideline, 2026. CA Cancer J Clin. 2026;e70083. doi:10.3322/caac.70083

  7. American Society for Gastrointestinal Endoscopy. ASGE position on blood-based colorectal cancer screening. Position statement. August 25, 2025. Accessed August 10, 2026. https://www.asge.org/home/practice-support/advocacy/policy-statements/blood-based-colorectal-cancer-screening

  8. Freenome reports top-line readout of updated SimpleScreen CRC colorectal cancer screening blood test met all primary and secondary endpoints. News release. Freenome, Inc.; July 9, 2026. Accessed August 10, 2026. https://www.freenome.com/newsroom/freenome-reports-top-line-readout-of-updated-simplescreen-crc-colorectal-cancer-screening-blood-test-met-all-primary-and-secondary-endpoints/