SimpleScreen CRC, approved by the US Food and Drug Administration, is indicated for adults aged 45 years and older at average risk for colorectal cancer and detects cell-free DNA signals associated with the disease from a blood sample, according to a press release from Freenome.
Colorectal cancer (CRC) remains the second-leading cause of cancer-related death in the US. According to the press release, an estimated 60 million Americans have not completed recommended screening.
The test is indicated for adults aged 45 years and older at average risk who are referred by a health care provider for CRC screening. A positive result indicates a signal that may suggest CRC or advanced precancerous lesions and should be followed by a colonoscopy. The test is not intended for diagnostic colonoscopy or surveillance colonoscopy in patients at increased risk.
The test was evaluated in the prospective PREEMPT CRC study, which Freenome described as the largest prospective clinical validation study conducted for a blood-based CRC screening test. The study enrolled more than 48,000 asymptomatic, average-risk adults aged 45 to 85 years at more than 200 sites who were scheduled to undergo screening colonoscopy.
In a prespecified analysis adjusted to reflect the US Census, SimpleScreen CRC demonstrated 81% sensitivity for CRC, 14% sensitivity for advanced precancerous lesions, including 31% sensitivity for advanced precancerous lesions with high-grade dysplasia, and 90% specificity for advanced colorectal neoplasia.
"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," said Aasma Shaukat, MD, MPH, of NYU Grossman School of Medicine, co-lead principal investigator of the PREEMPT CRC study.
According to the press release, with FDA approval, SimpleScreen CRC meets Medicare coverage criteria, and the company expects the test to be incorporated into American Cancer Society screening guidelines by name.
Source: Freenome
