FDA Approves Blood-Based Test for Colorectal Cancer Screening

The FDA has approved SimpleScreen™ CRC, a blood-based screening option, for use among adults 45 years and older who are at an average risk of developing colorectal cancer (CRC), according to a press release from the developer, Freenome, Inc.¹

The regulatory decision indicates that SimpleScreen CRC fulfills the coverage criteria for Medicare. Additionally, the screening option is anticipated to be incorporated into the American Cancer Society guidelines by name.

How does SimpleScreen CRC work?

Developers engineered SimpleScreen CRC to detect signals related to CRC based on cell-free DNA (cfDNA) in the blood. A positive result demonstrates that a signal was detected along with the presence of CRC or precancerous lesions. The press release noted that positive results should be acted upon with a colonoscopy. Furthermore, the test itself should not replace diagnostic colonoscopy or surveillance colonoscopy among high-risk populations.

Investigators previously assessed SimpleScreen CRC among more than 48,000 asymptomatic adults at an average risk for CRC in the PREEMPT CRC study (NCT04369053). A prespecified analysis matched to US Census data showed that SimpleScreen CRC detected disease with 81.1% sensitivity and advanced precancerous lesions with 13.7% sensitivity. Additionally, the test has produced a 90.4% specificity rate for detecting advanced colorectal neoplasia.

In a manuscript published in JAMA, investigators of PREEMPT CRC noted that SimpleScreen CRC demonstrated “acceptable accuracy” for CRC detection, although detection of advanced precancerous lesions remained a challenge at the time of analysis.² Data showed that sensitivity for CRC detection was 79.2% (95% CI, 68.4%-86.9%; P = .006) and that specificity for advanced colorectal neoplasia was 91.5% (95% CI, 91.2%-91.9%; P <.001). All primary end points fulfilled pre-specified acceptance criteria.

“The most effective screening test is the one a person will actually complete. Many people who should be screened for colorectal cancer simply aren’t,” Aasma Shaukat, MD, MPH, professor of medicine at NYU Grossman School of Medicine and a co-lead principal investigator on the PREEMPT CRC study, stated in the press release.¹ “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.”

How was PREEMPT CRC designed?

Investigators conducted the PREEMPT CRC study as a prospective, multicenter, observational study from May 2020 to April 2022, among adults 45 to 85 years old with an average risk of developing CRC and willingness to undergo standard-of-care screening colonoscopy. The study took place at 201 centers across 49 US states and the United Arab Emirates.

The trial’s primary end points included sensitivity for CRC, specificity for advanced colorectal neoplasia, negative predictive value for advanced colorectal neoplasia, and positive predictive value for advanced colorectal neoplasia. A secondary end point was sensitivity for advanced precancerous lesions.

Among 27,010 evaluable individuals who participated in the study, the mean age was 58.1 years (SD, 8.2), and most were 50 to 54 years old (32.9%) and female (55.8%). Additionally, most evaluable individuals were White (73.0%) and not Hispanic (83.0%).

“The fact is that 90% of [CRC] deaths are preventable, yet the disease will still claim more than 55,000 lives in the US this year alone. 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,” Anjee Davis, MPAA, chief executive officer of Fight Colorectal Cancer, said in the press release.¹ “[CRC] 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://tinyurl.com/4ba5xswf
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