With the recent approval of three new next generation sequencing diagnostic tests for tumor profiling, CDRH also announced their approach to regulating such tests. There are three levels of validated biomarkers addressed in each of the market authorizations for the new tests:
- Companion diagnostics-provide information for the safe and effective use of a companion therapeutic,
- Cancer mutations with evidence of clinical significance-biomarkers that allow health care professionals to use information about a tumor in accordance with clinical evidence, and
- Cancer mutations with potential clinical significance – biomarkers not considered level 1 or 2, which may be used for information or to guide patients toward relevant clinical trials.
CDRH will allow the holders of these market authorizations to report additional gene variants of the same type and claims as the existing analytically validated genes in the panel without an additional submission. A mutation may also be moved from level 3 to level 2 without a submission as the evidence of clinical significance becomes recognized by the clinical community. The key here is analytical validity of the biomarker in the panel. I look forward to additional refinements to this approach as the clinical use of these tests expands and additional next generation sequencing tests are approved.
Reach out to me if you want to know more or discuss your medical product development challenges.
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Text Copyright © 2020 Katrina Rogers