US-based NantHealth has received marketing authorisation from the US Food and Drug Administration (FDA) for its Omics Core assay, a whole exome sequencing in vitro diagnostic (IVD) test that can report overall tumour mutational burden (TMB) in cancer tissue.

In contrast to the commonly-used formulaic extrapolation of TMB from gene panel sequencing, the test enables TMB reporting by sequencing 19,396 protein-coding (whole exome) genes, targeting 39 million base pairs (39 Mb) of the human genome from the patient tumour, matching them with a regular sample to accurately determine the total TMB.

The country’s first FDA authorised custom-targeted whole exome sequencing platform Omics Core accurately reports somatic mutations in 468 cancer-relevant genes to 2% allele frequency, which in turn helps physicians to make proper treatment decisions.

TMB is a measurement of all acquired gene-coding mutations in a tumour genome. It is an emerging biomarker to identify tumours that may benefit from immunotherapy.

NantHealth chairman and CEO  Patrick Soon-Shiong said: “Tumour mutation burden (TMB) is now recognized as a key biomarker across multiple tumour types. Studies have shown that immunotherapy treated patients with high TMB had better outcomes compared to those with low TMB.

“Since the potential for TMB as a precision medicine tool is so high, it is imperative that the most accurate and comprehensive method of analysis be applied to enable physicians to determine which tumours could benefit from checkpoint inhibitors and immunotherapy.”

NantHealth’s product portfolio includes connected care solutions that provide medical device interoperability and molecular profiling services that include DNA & RNA tumor-normal whole genome profiling with pharmacogenomics analysis.