NantHealth Gets FDA Authorization for Omics Core Test

NantHealth (NASDAQ:NH) has been granted marketing authorization for its Omics Core test from the US Food and Drug Administration (FDA), the company said on Tuesday (November 12).

The Omics Core test is the first FDA-authorized whole-exome tumor-normal in vitro diagnostic that measures tumor mutational burden (TMB) in cancer tissue. TMB measures how many mutations are found in a tumor and pinpoints which tumors may reap the benefits of immunotherapy.

NanThealth said its Omics Core technology can report TMB by sequencing over 19,000 protein-coding genes in addition to somatic alterations — such as insertions and deletions — in roughly 470 cancer-related genes with a 2 percent allele frequency, which the company said will help healthcare professionals make treatment decisions.

Patrick Soon-Shiong, M.D., chairman and CEO of NantHealth, said in a release that his company’s Omics Core diagnostic will be beneficial in providing better accuracy than the existing formulaic extrapolation of TMB “from a limited gene panel sequence.”

“Clinicians can now directly measure the mutations in a patient’s tumor specimen accurately via tumor-normal sequencing and have confidence that the results they receive are fully validated to help support better therapeutic decisions,” said Bobby Reddy, M.D., NantHealth’s chief medical officer.

Reddy added that a whole exome also means that additional neoepitopes — a peptide class that is a result of tumor-specific mutations — and targets can further be identified for vaccine development, novel drug development and other therapies for otherwise untreatable targets.

Tuesday’s announcement comes just days after the company released its Q3 2019 financial results, highlighting quarterly revenue of US$22.4 million, up from US$22.3 million in the same period in 2018.

For the first nine months of the year, NantHealth posted a net loss of US$51 million compared to a US$143 million net loss for the first nine months of 2018. However, the company indicated it is cash flow positive, rising from US$2.3 million in Q2 2019 to US$9.3 million in Q3.

Shares of NantHealth were up 10.21 percent from its previous close to US$0.77 as of market close on Tuesday. Year-to-date, the company’s share price is up over 35 percent. Based off one analyst rating on TipRanks, NantHealth is currently ranked a “moderate buy” with an average price target of US$1.

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Securities Disclosure: I, Jocelyn Aspa, hold no direct investment interest in any company mentioned in this article.