On September 28, 2018, FDA issued a press release with extensive comments by Commissioner Dr. Scott Gottlieb regarding availability of a novel form of sequencing for use in acute leukemia (ALL).
The test is the ClonoSEQ in vitro diagnostic, which will be able to offer new levels of sensitivity in detecting minimum residual disease (MRD). The test can be positioned as a more sensitive alternative to conventional flow cytometry or PCR assays. It produces a patient-specific or "fingerprint" analysis with sensitivities below 1 per million cells. ClonoSEQ uses PCR amplification of target sequences and NGS detection.
FDA Praises Its Commitment to Genomic Innovation, While Calling for Legislative Improvements
Gottlieb speaks of the test as "an important step forward for patients suffering from ALL and multiple myeloma."
In addition, he highlighted that FDA itself is "continuing to maximize opportunities for innovation" and that "The FDA is applying novel regulatory approaches to make sure that these rapidly evolving NGS tests are accurate and reliable." In what I see as a key perspective, he stressed that the FDA "is doing as much as we can...under current authorities. But we believe that to fully unlock these innovations, we need to modernize the regulatory framework for all in vitro clinical tests." In making these statements, Gottlieb was explicitly referencing the FDA's own proposal for legislative innovation which it recently made to Congress. See his September 13 speech here.
Further reporting at Genomeweb here. At OncLive, here.
MolDx
MolDx released proposed coverage for ClonoSEQ in August, here.
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MolDx recently updated its Technical Assessment Checklist (web here, M00151 V4, cloud PDF here). This September 2018 document contains reference to a September 14, 2018, Excel spreadsheet checklist specific to "Somatic Variant Detection by Comprehensive Genetic Profiling for Myeloid Tumors Checklist M00153". See link here, my cloud copy here. This M00153 spreadsheet has some very specific requirements, such as "copy of current CLIA certificiate" (which Medicare would already have on file for a lab), a table to fill in that is about 250 lines long and about 10 wide, and other requirements at bottom.
In M00153, I was surprised to see a query whether "Reports are issued by a physician, board certified by ABP or ABMGG" since molecular reports are classically signed out by either a physician or a PhD lab director. There is also question whether the lab submits variants to ClinVar, which seems irrelevant questioning if not this is not part of the coverage decision, or very important to note if it is part of a coverage decision.
