He emphasizes the importance of careful definition of an intended use and intended use population.
He highlights three special issues arising in the past year as (1) tissue agnostic indication for Keytruda; (2) 510(k) clearance for MSK IMPACT test; and (3) the CMS NCD for NGS in advanced cancer.
Regarding tissue agnostic indications and Keytruda, he highlights the very limited amount of data available on the Keytruda labeling at the time of tissue agnostic accelerated (provisional) approval.
Humorously, he introduces the CMS with a slide showing the famous "Serenity Prayer" (Grant me the patient to accept what I cannot change...) He notes that tests like MSK IMPACT had guaranteed coverage in the NCD draft version (albeit with burdensome CED) and have only potential LCD coverage in the final NCD. He notes that MSI and TMB are "inside" the FMI F1 CDx test, but "not" listed as CDx per se.
He makes a number of points on regulation of lab tests:
- He asks rhetorically, if CMS can require FDA approval for tests, can MACs do so (if they want to).
- Regarding "regulation," he notes that Exact Sciences with an FDA approved test has a market cap of $6B, much higher than companies with LDT tests (Genomic Health has a market cap of $1B).
- He notes that physicians said CLIA '88 would be very bad with patients and trash access to lab tests, but it didn't.
For reinforcing recommendation for more highly validated and also higher reimbursed diagnostics, see Hayes 2014 here.