GRAIL

Machine learning on targeted methylation data is what converts a blood draw into a cancer signal and a predicted tissue of origin, and peer reviewed literature describes the ML algorithms as central to the method. Held back from A because the product is a wet lab assay plus an ML classifier: the sequencing chemistry is as load bearing as the model, and the two cannot be separated.

The deepest evidence base in the index. PATHFINDER 2 enrolled 25,490 participants; the NHS-Galleri trial enrolled more than 140,000 asymptomatic participants aged 50 to 77 and is the only prospective randomized controlled trial of a multi cancer early detection test for population screening. Vendor reported PATHFINDER 2 results include 92 percent accuracy in identifying cancer signal origin and a median 46 day diagnostic resolution. Graded on the existence, scale, and design of the evidence; this index does not re verify the underlying results, and the NHS-Galleri primary endpoint of late stage cancer reduction is the claim that ultimately matters.

Regulatory positioning is stated with exemplary precision. Galleri holds FDA Breakthrough Device designation (2018), GRAIL submitted the final module of its Premarket Approval application in January 2026, and the test is currently offered as a laboratory developed test pending that decision. The company does not describe the test as FDA approved. This axis grades clarity of positioning, and GRAIL is the reference standard for it.

No published rate card for health system or employer channel purchasing. Contact the vendor. Consumer facing pricing exists for the individual test but the B2B channel this index covers is contract based.

Scope is explicit: multi cancer early detection as an addition to standard of care single cancer screening, in adults typically over 50, with signals reported across more than 50 cancer types. Intended use is clearly bounded as a complement to and not a replacement for existing screening.