Caris Life Sciences vs Freenome

FDA approved Caris MI Cancer Seek as PMA P240010 in November 2024, with companion-diagnostic claims that include EGFR exon 19 deletions and L858R. It sequences FFPE tumor tissue for SNVs and indels in 228 genes, MSI and TMB, and the Caris page gives a median turnaround of 8 days. A medical oncologist treating a diagnosed cancer orders it, which is not a buyer the primary care or gastroenterology group screening average-risk adults shares with Freenome.

Freenome's SimpleScreen CRC won approval under PMA P250029 in July 2026. It is a blood test for colorectal cancer screening in adults 45 and older at average risk, and a positive result is followed by colonoscopy. The vendor reports 81.1% sensitivity for colorectal cancer, 13.7% for advanced precancerous lesions and 90.4% specificity for advanced colorectal neoplasia. Abbott will commercialize it exclusively in the US starting in fall 2026, so a primary care or gastroenterology group buys through Abbott instead of Freenome.