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.