From time to time I get questions about what FDA review is like for a next generation sequencing test, or why the FDA review takes so long.
Not new-new, but still of interest. In spring 2020, Personal Genome Diagnostics (PGDx) got FDA clearance for a several-hundred-gene tumor test. It's 510(k) clearance, the predicate being the Memorial Sloan Kettering IMPACT test, which was de novo 510(k).
For Medicare types, the ELIO test isn't automatically covered under CMS Next Gen Sequencing NCD 90.2, because it isn't a "companion diagnostic" test. However, it can be covered by local MACs. It went through a separate post-FDA review process at MolDx until September 2020 (here). MolDx apparently assigned the test to code 81479 (other molecular test) rather than 81455 (tumor gene panel > 50 genes). In 2021, the saga continued, with PGDx ELIO getting a PLA code in the spring, 0250U, which was crosswalked to the price of 81455 (about $2900) in November 2021. The test includes mutations, small indels, 1 amplification, 4 translocations, and also MSI and TMB.
Here are links to the key FDA pages:
FDA Home Page for the test, links, and updates:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K192063
FDA authorization letter, 32pp:
https://www.accessdata.fda.gov/cdrh_docs/pdf19/K192063.pdf
FDA safety and effectiveness review, 108pp:
https://www.accessdata.fda.gov/cdrh_docs/reviews/K192063.pdf
(In contrast, the PMA review of the original Foundation Medicine CDx panel, was only about 50 pp).
The test is classified as FDA product code "PZM" and falls under 510(k) regulatory classification 21 CFR 866.6080.
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For the Foundation One "Liquid" CDx approval, here. it's product type PQP, but doesn't have a regulatory classification at 21 CFR since it's PMA not 510(k).
The PAIGE AI software system for prostate biopsies got FDA De Novo in September 2021; its full evaluation documents are not yet posted by FDA but will appear here (DEN 200080, 21 CFR 864.3750, code QPN.)
