The U.S. FDA has approved Freenome's SimpleScreen CRC, a blood-based screening test for colorectal cancer in adults aged 45 and older—the company's first commercial product. Partner Abbott will exclusively commercialize it in the U.S. starting this fall, competing with Guardant Health's Shield test.
The test detects cancer signals from circulating DNA fragments. In a 48,000-person study, it showed 81.1% sensitivity for colorectal cancer and 13.7% for advanced precancerous growths
The U.S. FDA has approved Freenome's (FRNM.O), opens new tab blood-based colorectal cancer screening test for older adults, paving the way for partner Abbott (ABT.N), opens new tab to launch it in the U.S. this fall, the companies said on Monday.
Shares of Freenome were up about 4% in morning trading.
Here are some more details:
- The U.S. Food and Drug Administration's approval for average-risk adults aged 45 and older gives Freenome its first commercial product.
- Abbott will exclusively commercialize the test in the U.S., where it will compete with Guardant Health's (GH.O) FDA-approved Shield blood test.
- The large number of unscreened Americans leaves room for multiple blood-based screening providers, TD Cowen analyst Dan Brennan said.
- The test, SimpleScreen CRC, detects signals linked to colorectal cancer from DNA fragments circulating in the blood.
- Abbott is likely to market SimpleScreen to people who do not complete or decline stool-based screening tests, Brennan said.
- It was evaluated in a large study that enrolled over 48,000 adults across more than 200 sites.
- In the study, the test detected colorectal cancer with 81.1% sensitivity in a prespecified analysis. It also detected advanced precancerous growths with 13.7% sensitivity, including 30.7% sensitivity for high-risk precancerous growths.
- With the approval, the test meets Medicare coverage criteria, while blood-based colorectal cancer screening is already included in updated American Cancer Society screening guidelines.
- Freenome will receive a $100 million milestone payment from Abbott tied to the approval under the commercialization deal signed in 2025.
- Freenome said it plans to develop more blood-based cancer screening tests, including for lung cancer, using the same technology platform.
- Colorectal cancer, which affects the colon or rectum, is the third-most common cancer diagnosed in the U.S., according to the American Cancer Society.
