FDA Approves Freenome Blood Test for Colorectal Cancer Screening

The US Food and Drug Administration (FDA) has approved Freenome's SimpleScreen™ CRC, a blood-based colorectal cancer (CRC) screening test for adults aged ≥45 years who are at average risk for the disease, providing clinicians with a second FDA-approved blood-based screening option for eligible patients.

The approval was supported by findings from the PREEMPT CRC study, the largest prospective clinical validation study conducted for a blood-based colorectal cancer screening test. SimpleScreen CRC detects cell-free DNA (cfDNA) signals associated with colorectal cancer from a blood sample and is intended for screening asymptomatic adults at average risk.

Colorectal cancer remains the second-leading cause of cancer-related death in the United States despite being highly preventable through routine screening. According to Freenome, up to 60 million Americans remain overdue for recommended screening, highlighting the need for additional screening options that may improve participation among eligible adults.

"The most effective screening test is the one a person will actually complete," said Aasma Shaukat, MD, MPH, professor of medicine at NYU Grossman School of Medicine and co-lead principal investigator of the PREEMPT CRC study. "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."

PREEMPT CRC Results

FDA approval was based on results from PREEMPT CRC, a prospective clinical validation study conducted at more than 200 sites that enrolled more than 48,000 asymptomatic adults aged 45-85 years at average risk for colorectal cancer who were scheduled to undergo screening colonoscopy.

In a prespecified analysis adjusted to reflect the US Census population, SimpleScreen CRC demonstrated:

• 81.1% sensitivity for colorectal cancer
• 13.7% sensitivity for advanced precancerous lesions (APLs)
• 30.7% sensitivity for APLs with high-grade dysplasia
• 90.4% specificity for advanced colorectal neoplasia

According to the company, the findings indicate the blood test correctly detected approximately 8 in 10 colorectal cancers while correctly producing negative results for about 9 in 10 individuals without colorectal cancer or advanced precancerous lesions.

Clinical Implications

SimpleScreen CRC becomes the second FDA-approved blood-based screening test for colorectal cancer in average-risk adults. The approval expands the range of noninvasive screening options available to clinicians alongside stool-based testing, colonoscopy, CT colonography, and flexible sigmoidoscopy.

As with other noninvasive colorectal cancer screening tests, a positive SimpleScreen CRC result should be followed by diagnostic colonoscopy. The test is intended for adults aged ≥45 years who are at average risk for colorectal cancer and is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals.

Freenome stated the FDA approval meets Medicare coverage criteria for the test and said it expects SimpleScreen CRC to be incorporated into future American Cancer Society screening guidance by name, which could further expand access to blood-based colorectal cancer screening for eligible adults. Abbott plans to exclusively commercialize the test in the United States beginning this fall.

References

1. 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.

2. 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.