FDA Clears Whole Exome Tumor Test for NantHealth; 510(k)

On November 12, 2019, NantHealth announced it had received a first in class FDA clearance for an NGS-based whole exome test.   In addition to sequencing some 19,000 genes and 39 million base pairs, the test reports the same 468 cancer-relevant genes reported by the Memorial Sloan-Kettering IMPACT test, a predicate test for NantHealth.  IMPACT was a de novo clearance in November 2017.  Nanthealth's test also reports tumor mutational burden (TMB.)

The branded name is OMICS CORE.

• See NantHealth press release here.
• See open access summary at Genomeweb here.
• See open access at Clinical Omics here.
• FDA tracks the test as K190661 here.
• See the 180-page FDA decision summary, K190661, here.
• See Genomeweb on the decision summary, here.

The 57-page 2017 FDA evaluation of MSK IMPACT (DEN 170058) is online here.  it will be very interesting to see the FDA's published validation requires for whole exome in Nanthealth's FDA review.

It's hard to be sure from the short press releases, but it may be that the test reports the 468 genes (like IMPACT) but uses exome to calculate TMB (or for research data).

NantHealth's most recent investor call, November 7, is online here.  NantHealth was up 10% today, to $0.76 with a market cap of $85M.  (Current assets are about $28M; retained earnings are -$918M; initial valuatoin was $1.7B.)  In 2017 and 2018, each year NantHealth had about $85-90M revenue against net lincome (loss) of about $175-190M.