FDA approves Freenome's blood test for colorectal cancer screening

July 27 — The U.S. FDA has approved Freenome's blood-based colorectal cancer screening test ​for older adults, paving the way for partner Abbott 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 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.

(Reporting by Sahil Pandey in Bengaluru; Editing by ​Sahal Muhammed)

Related topics