SimpleScreen CRC Blood Test Meets Endpoints in Clinical Validation Study

Freenome reported top-line results for an updated version of its SimpleScreen CRC blood-based colorectal cancer screening test, with the pivotal clinical validation study meeting primary and secondary endpoints, according to a July 9, 2026, announcement.¹

The updated assay and algorithm showed 80.4% sensitivity for colorectal cancer (CRC), 18.2% sensitivity for advanced precancerous lesions (APLs), 41.9% sensitivity for APLs with high-grade dysplasia (HGD), and 90% specificity among participants with no findings on colonoscopy, the company reported.¹

"The sensitivity for APL and APL with HGD for the updated SimpleScreen CRC test is a marked improvement and gets us closer to matching the performance of certain stool-based CRC screening tests, with potentially higher adherence," Aasma Shaukat, MD, MPH, professor of medicine at NYU Grossman School of Medicine and a co-lead principal investigator on the PREEMPT CRC study, said in a statement.¹

What the SimpleScreen CRC Validation Study Reported

The clinical validation analysis used samples from PREEMPT CRC, a prospective registrational study conducted at more than 200 sites. The parent study enrolled 48,995 asymptomatic, average-risk adults aged 45 to 85 years who were scheduled to undergo screening colonoscopy.^1,2 Freenome stated the updated test validation included blinded, previously unevaluated samples from PREEMPT CRC, along with previously tested samples.

The analysis included 89 individuals with CRC, 1570 with APLs, and 157 with APLs with HGD in the US Census–weighted endpoint analysis. Sensitivity for CRC was 80.4% (95% CI, 70.2%-87.7%). By stage, sensitivity was 52% for stage I CRC, including 39.9% for T1 and 81.2% for T2 disease, 100% for stage II, 97.3% for stage III, and 100% for stage IV CRC.¹

For precancerous lesions, sensitivity was 18.2% (95% CI, 16.3%-20.4%) for APLs and 41.9% (95% CI, 34.0%-50.3%) for APLs with HGD. Freenome compared these findings with its first-generation SimpleScreen CRC test, which showed 81.1% CRC sensitivity, 13.7% APL sensitivity, and 30.5% HGD sensitivity in PREEMPT CRC.^1,2 The company described the improvement in lesion detection as driven by assay and algorithm updates.

"This study marks a major milestone in our mission to advance blood-based colorectal cancer screening," said Aaron Elliott, PhD, CEO of Freenome. "The significant improvement in detecting precancerous lesions demonstrates the critical role our SimpleScreen CRC platform can play in early detection and prevention of colon cancer. With millions of eligible Americans still not getting screened, expanding access to accurate, non-invasive screening options that patients are more likely to complete has never been more important."

FDA Review and Colorectal Cancer Screening Context

Freenome submitted a premarket approval application to the US Food and Drug Administration (FDA) in August 2025 for the first-generation SimpleScreen CRC test and stated agency review was expected to be completed in mid 2026. The company plans to submit a supplemental premarket approval application for the updated test.¹

Current US Preventive Services Task Force recommendations support CRC screening for adults aged 45 to 75 years, with individualized decisions for adults aged 76 to 85 years.³ Recommended strategies include stool-based tests, direct visualization, and other approved approaches. Blood-based CRC screening tests are being studied as a less invasive option, particularly for individuals who do not complete currently recommended screening, but performance characteristics vary by test and endpoint.

Freenome stated more than 50 million eligible US adults are not up to date with recommended CRC screening.¹ The company also reported modeling projected the updated version, compared with its first-generation test, would produce 1582 additional life-years gained, 426 fewer CRC cases, and 143 fewer CRC deaths per 100,000 screened individuals.

Safety, Limitations, and Next Steps for SimpleScreen CRC

The July 9 announcement did not report adverse event data or blood draw–related safety findings. The main reported performance measures were sensitivity for CRC, sensitivity for APLs, sensitivity for APLs with HGD, and specificity among individuals with no colonoscopy findings.¹

The company’s first-generation SimpleScreen CRC results were previously published in JAMA in 2025.² In the new announcement, Freenome characterized the updated test as a next-generation version based on assay and algorithm improvements. Freenome also noted its commercial collaboration with Abbott, under which Abbott would commercialize SimpleScreen CRC after FDA approval.¹ The regulatory status of the updated assay will depend on FDA review of the planned supplemental submission.

References

1. Freenome Holdings, Inc. Freenome reports top-line readout of updated SimpleScreen CRC colorectal cancer screening blood test met all primary and secondary endpoints. PR Newswire. Published July 9, 2026. https://www.prnewswire.com/news-releases/freenome-reports-top-line-readout-of-updated-simplescreen-crc-colorectal-cancer-screening-blood-test-met-all-primary-and-secondary-endpoints-302821493.html

2. Shaukat A, Burke CA, Chan AT, et al. Clinical validation of a circulating tumor DNA-based blood test to screen for colorectal cancer. JAMA. Published online June 2, 2025. doi:10.1001/jama.2025.7515

3. US Preventive Services Task Force. Screening for colorectal cancer: US Preventive Services Task Force recommendation statement. JAMA. 2021;325(19):1965-1977. doi:10.1001/jama.2021.6238