On Jul. 28, 2026, The U.S. Food and Drug Administration (FDA) announced it had 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.

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.

Freenome and Abbott announced that the FDA has approved SimpleScreen CRC for adults aged 45 and older who are at average risk for CRC and have been referred by a clinician for screening. The test uses a routine blood draw to identify CRC-associated methylation signals in cell-free DNA. Abbott plans to exclusively commercialize the test in the United States beginning in fall 2026.

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.