Key takeaways:
- SimpleScreen CRC detects signals linked to CRC from cell-free DNA in a blood sample.
- The test detected CRC with 81.1% sensitivity and advanced precancerous lesions with 13.7% sensitivity.
The FDA has approved a second blood-based colorectal cancer screening option for adults aged 45 years and older at average risk for the disease.
SimpleScreen CRC (Freenome) is a noninvasive test that assesses cell-free DNA in a blood sample to detect signals associated with CRC. A positive result suggests CRC or advanced precancerous lesions and should be followed by colonoscopy, according to a manufacturer press release.
An estimated 60 million people eligible for screening in the U.S. are overdue, despite CRC being the second-leading cause of cancer-related deaths.
“The fact is that 90% of colorectal cancer deaths are preventable, yet the disease will still claim more than 55,000 lives in the U.S. this year alone,” Anjee Davis, MPAA, CEO of Fight Colorectal Cancer, said in the release. “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.”
The FDA based its decision on results from the multicenter PREEMPT CRC study, which enrolled more than 48,000 adults aged 45 to 85 years at average risk for CRC, asymptomatic and scheduled for a screening colonoscopy.
Results showed SimpleScreen CRC had a 90.4% specificity for advanced colorectal neoplasia and sensitivities of 81.1% for CRC, 13.7% for advanced precancerous lesions and 30.7% for lesions with high-grade dysplasia.
Earlier this year, CMS adopted performance-based standards to qualify biomarker-based CRC tests for Medicare coverage, which SimpleScreen CRC now meets with this approval.
Abbott will exclusively commercialize the test in the U.S. this fall and use its established CRC infrastructure, which includes the Nexus platform, to encourage screening and test adoption in the health care system.
SimpleScreen CRC also is expected to be incorporated into American Cancer Society guidelines, according to the release. That guidance was recently updated to recommend blood-based CRC screening options for patients who decline or do not complete more sensitive screening options like stool-based tests or colonoscopy.
“The most effective screening test is the one a person will actually complete,” Aasma Shaukat, MD, MPH, professor at NYU Grossman School of Medicine and colead principal investigator on the PREEMPT CRC study, said in the 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.”
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