FDA Approves New Blood Test for Colon Cancer Screening

 The FDA approved SimpleScreen CRC, a blood-based screening test for adults 45 years and older who are at average risk for colorectal cancer (CRC), Freenome announced.

SimpleScreen CRC joins Guardant Health's Shield test, which was the first approved blood-based screening option for CRC.

In recently updated guidelines, the American Cancer Society said blood-based screening tests are not recommended as a preferred option, but can be offered to individuals who decline or can't complete preferred screening tests.

Approval was based on data from the PREEMPT CRC study, which was conducted at over 200 sites and enrolled more than 48,000 asymptomatic, average-risk adults ages 45 to 85 who were scheduled for a screening colonoscopy.

In a prespecified analysis adjusted to match the U.S. Census, SimpleScreen CRC detected colorectal cancer with 81.1% sensitivity and advanced precancerous lesions (APLs) with 13.7% sensitivity (30.7% for APLs with high-grade dysplasia). In addition, the test showed a specificity of 90.4% for advanced colorectal neoplasia.

"The most effective screening test is the one a person will actually complete," said Aasma Shaukat, MD, MPH, of the NYU Grossman School of Medicine in New York City, a co-lead principal investigator on the PREEMPT CRC trial, in the company's press 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."

CRC is the second-leading cause of cancer-related death in the U.S., but when found early, it is preventable and treatable. Up to 60 million Americans are overdue for recommended screening, highlighting the need for convenient screening options, Freenome said.

The test involves a simple blood draw and detects signals associated with CRC from cell-free DNA. A positive result indicates that a signal was detected, which may suggest the presence of colorectal cancer or APLs and should be followed by colonoscopy, the company explained. The test is not a replacement for diagnostic colonoscopy or for surveillance colonoscopy in high-risk individuals.

Freenome noted that the test meets coverage criteria for Medicare, which will help expand access to blood-based CRC screening for eligible adults.

https://www.medpagetoday.com/hematologyoncology/coloncancer/122363