Thursday, November 21, 2019

Very Very Brief Blog: FDA Posts Decision Summary for Nanthealth Tumor Exome (182pp)

On November 12, 2019, FDA approved use of the NantHealth tumor somatic, germline, and exome test.   See entry point here with additional background and links.

FDA has now released the 182-page review document - K190661 - here.   See also a deep dive article at Genomeweb here.   The FDA home page for the device is here.

I haven't read the whole FDA review, but it shows the commitment of the FDA to finding creative ways to approve very advanced NGS diagnostics with huge amounts of sequencing data.