Dive Brief:
- The Food and Drug Administration has approved Freenome’s blood-based screening test for colorectal cancer, called SimpleScreen CRC. Abbott will exclusively market the test in the U.S., starting this fall, the companies said Monday.
- Abbott already sells the Cologuard stool test for colorectal cancer screening, following its $21 billion acquisition of Exact Sciences earlier this year. Through its collaboration with Freenome, Abbott now adds a blood test to its colorectal cancer screening portfolio.
- SimpleScreen will compete with Guardant Health’s Shield blood test for colorectal cancer screening, which gained FDA approval in 2024. TD Cowen analysts said that with a very large population of patients who are unscreened, “We see room for multiple players.”
Dive Insight:
Both SimpleScreen and Shield are approved for adults 45 and older who are at average risk for colorectal cancer. As many as 60 million Americans are overdue for recommended screening, according to Freenome.
While colonoscopy is the gold standard for colorectal cancer detection, the screening gap illustrates the need for more convenient approaches, the company said.
The TD Cowen analysts said they expect Abbott to prioritize Cologuard, which offers better performance than both SimpleScreen and Guardant’s blood-based test, adding that Abbott “will likely seek to market blood/SimpleScreen in cases where Cologuard is refused (and as well where orders are not completed).”
Freenome retains U.S. rights to commercialize the current SimpleScreen test and future versions as part of a multicancer early detection offering, the TD Cowen analysts said.
SimpleScreen detects cancer signals from cell-free DNA in the blood. Freenome said the FDA approval is based on the PREEMPT CRC study of more than 48,000 people that detected about 8 in 10 colorectal cancers. The test also correctly provided negative results for 9 of 10 people without colorectal cancer or advanced precancerous lesions.
The company, which went public earlier this month, will receive a $100 million milestone payment from Abbott as a result of the FDA approval, under a commercial agreement the partners inked in August 2025.
