Caris Life Sciences vs Indica Labs HALO AI

Caris and Indica both hold FDA records that cover something other than their AI. Caris's PMA P240010 (approved November 5, 2024) covers the MI Cancer Seek sequencing assay and its companion diagnostic claims. The GPSai tissue-of-origin model and FOLFIRSTai are listed under professional services, outside the FDA-approved scope. Indica's K232833 (May 7, 2024) and K252762 (November 25, 2025) cover HALO AP Dx, the case-centric platform for primary diagnosis, and not the HALO AI add-on.

The sequencing report goes to the oncologist's desk, and the viewer and classifier go to a pathology department or pharma group, so each tool has its own buyer. Caris takes FFPE tumor samples for 228-gene profiling with companion diagnostic claims such as PIK3CA for Piqray. Caris says median turnaround is 8 days, and the same page also gives 6 to 9. HALO AP Dx is cleared with the Aperio GT 450 DX and the Hamamatsu NanoZoomer S360MD, and the research classifier is tuned by the lab itself.