FDA-Backed Tumor Mutation Database Gives Diagnostics Developers Another Premarket Submission Tool
The US FDA on 7 October recognized a portion of the Oncology Knowledge Base, or OncoKB, which test makers can use as they work to complete premarket submissions. It’s the first database of somatic variants in cancer to be listed in the agency’s Public Human Genetic Variant Databases.
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The agency says it has evaluated ClinGen and will accept evidence based on the US National Institutes of Health-funded database for product applications. It hopes the use of the database will spur development of targeted treatments and diagnostics such as next generation sequencing tests.
The promise of next-generation sequencing technology to help patients understand risk and target treatment for disease is high. US FDA is hoping to help accelerate practical advancements with the release of two final guidances addressing NGS technology and databases that aggregate genomic information.
In this FINAL EPISODE of Speaking Of Medtech: The US FDA got something it desperately wanted in its latest user-fee package with industry: a Total Product Lifecycle Advisory Program pilot, or TAP. The agency says TAP will allow for earlier and more frequent engagement with developers – but is it needed?