GRAIL vs Ibex Medical Analytics

Ibex Prostate Detect is FDA-cleared under 510(k) K241232, decision January 24, 2025, as Galen Second Read. Beyond that, the vendor lists CE marking for several solutions, IVDR marking for Ibex First Read in prostate, and UK MHRA and ANVISA Brazil registration. Ibex Medical Analytics of Tel Aviv raised a $55 million Series C in September 2023, led by 83North. A laboratory director with prostate biopsy volume is the buyer.

GRAIL's Galleri starts with a blood sample a physician orders, so it reaches patients through a clinic and not through a pathology lab. galleri.com says the test has not been cleared or approved by the FDA, and GRAIL says it is sold as a CLIA-lab test. The PMA, submitted in full on January 29, 2026, is under FDA review. The advisory panel voted 7 yes, 2 no and 1 abstention on September 23, 2026 that benefits outweigh risks, with effectiveness at 6 yes and 4 no. Per Diagnosis (Berl) and BMJ coverage, the NHS-Galleri trial missed its primary endpoint.