FDA Approves Freenome's SimpleScreen CRC Blood Test
FDA approval triggers a $100 million payment from Abbott under the companies’ commercialization agreement.
The FDA has approved Freenome’s SimpleScreen CRC, a blood-based screening test for colorectal cancer in adults 45 and older at average risk.
In a July 27 announcement, Freenome said Abbott will exclusively commercialize the test in the US starting this fall. Under the companies’ August 2025 commercial agreement, Freenome will receive a $100 million milestone payment from Abbott tied to this approval. Abbott plans to sell SimpleScreen CRC alongside the Cologuard test it acquired via Exact Sciences earlier this year.
“Today’s approval is an important validation of the scientific vision we’ve spent more than a decade building,” Freenome CEO Aaron Elliott said in a statement. “SimpleScreen CRC is the first commercial realization of our Personalized Cancer Detection strategy, built on base-level cfDNA methylation and AI-enhanced accuracy.” The company said it plans to fold SimpleScreen CRC into a broader screening portfolio and continue developing tests for lung cancer and other indications on the same underlying platform.
SimpleScreen CRC detects colorectal cancer signals from cell-free DNA in a standard blood draw. Colorectal cancer is the second-leading cause of cancer death in the US, and up to 60 million Americans remain overdue for recommended screening, according to Freenome.
“While the full label isn’t available yet, this [FDA] Approval Order Statement language is aligned with that of [Guardant Health’s] Shield” test, approved in 2024, Guggenheim Securities Analyst Subbu Nambi wrote in a July 27 note to investors.
The FDA order for SimpleScreen CRC also noted:
Patients with a positive result should be followed by colonoscopy. SimpleScreen CRC is not a replacement for diagnostic colonoscopy or for surveillance colonoscopy in high-risk individuals.