FDA Approves SimpleScreen Blood Test for CRC Screening

The FDA has approved SimpleScreen CRC (Freenome), a blood-based screening option for colorectal cancer (CRC), for adults aged 45 and older who are at average risk for the disease, with Abbott planning to commercialize the test this fall.¹

SimpleScreen CRC detects signals associated with CRC from cell-free DNA (cfDNA) in the blood. In a prespecified analysis from the PREEMPT CRC study (NCT04369053) adjusted to match the US Census population distribution, the test demonstrated a sensitivity of 81.1% for CRC detection and 13.7% for advanced precancerous lesions (APLs), including 30.7% for APLs with high-grade dysplasia.¹ Specificity for advanced colorectal neoplasia was 90.4%.¹ In practical terms, the test correctly identified approximately 8 in 10 CRC cases and produced a negative result in 9 of 10 people without CRC or advanced precancerous lesions.

The PREEMPT CRC data were published in JAMA in June 2025, where the primary analysis in 27,010 consecutively enrolled participants showed a CRC sensitivity of 79.2% (95% CI, 68.4%-86.9%; P = .006) and specificity for advanced colorectal neoplasia of 91.5% (95% CI, 91.2%-91.9%; P <.001), with all primary end points meeting prespecified acceptance criteria.² In adults aged 45 to 49, among whom only approximately 20% are current with recommended screening, the test showed 100% sensitivity for CRC and 94.8% specificity for advanced colorectal neoplasia.²

Freenome is also developing an updated next-generation version. Data presented at the 2026 ASCO Gastrointestinal Cancers Symposium showed the updated test achieved 80.4% to 85% sensitivity for CRC and 18.2% to 22% sensitivity for APLs at 90% specificity, reflecting improvement in precancer detection over the approved first-generation version.³

"The most effective screening test is the one a person will actually complete," Aasma Shaukat, MD, MPH, professor of medicine at NYU Grossman School of Medicine and a co-lead principal investigator on PREEMPT CRC, stated in a news release. "Many people who should be screened for colorectal cancer simply aren't. A blood-based test provides another way to reach unscreened patients, and bringing more people into the screening fold leads to earlier detection and better outcomes."

About PREEMPT CRC and Clinical Development

PREEMPT CRC enrolled more than 48,000 asymptomatic, average-risk adults aged 45 to 85 at more than 200 sites across the United States who were scheduled for a routine screening colonoscopy, with colonoscopy findings serving as the reference standard.¹ The study used a hybrid recruitment strategy to broaden diversity, with more than 11% of participants identifying as Black or African American and more than 11% as Hispanic or Latino.²

SimpleScreen CRC is indicated for adults aged 45 and older at average risk for CRC who have been referred by a healthcare provider. A positive result should be followed by colonoscopy. The test is not a replacement for diagnostic or surveillance colonoscopy in high-risk individuals.¹

With FDA approval, SimpleScreen CRC meets Medicare coverage criteria and has been incorporated into the updated American Cancer Society guidelines for CRC screening.¹

"The fact is that 90% of colorectal cancer deaths are preventable, yet the disease will still claim more than 55,000 lives in the US this year alone," Anjee Davis, MPAA, chief executive officer of Fight Colorectal Cancer, stated in the news release.¹ "Regular screening is the key to reversing that trend, and new, minimally invasive screening options that help more people get screened are a critical part of that process. Colorectal cancer is increasingly affecting younger adults, and a screening test that fits into a routine visit, accompanied by prompt follow-up in response to an abnormal result, can play an important role in driving earlier treatment and prevention."

References

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

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. 2025;334(1):56-63. doi:10.1001/jama.2025.7515

3. Freenome delivers improved performance in its colorectal cancer blood test with sensitivity of 85% for CRC and 22% for advanced precancerous lesions. News release. Freenome Inc. January 6, 2026. Accessed July 27, 2026. https://www.prnewswire.com/news-releases/freenome-delivers-improved-performance-in-its-colorectal-cancer-blood-test-with-sensitivity-of-85-for-crc-and-22-for-advanced-precancerous-lesions-302653396.html