The FDA has granted marketing authorization to NantHealth’s Omics Core test, clearing what it said is the nation’s first whole exome tumor-normal in vitro diagnostic (IVD) designed to measure overall tumor mutational burden (TMB) in cancer tissue. [7activestudio/Getty Images]

The FDA has granted marketing authorization to NantHealth’s Omics Core test, the company said today, clearing what it said is the nation’s first whole exome tumor-normal in vitro diagnostic (IVD) designed to measure overall tumor mutational burden (TMB) in cancer tissue.

Omics Core is the first FDA authorized custom-targeted whole exome sequencing platform to report both overall TMB in tumor specimens from 19,396 protein-coding genes (whole exome) and somatic alterations—including point mutations, small insertions, and deletions—in 468 cancer-relevant genes, NantHealth said.

The test is intended to enable TMB reporting by sequencing 19,396 protein-coding genes (whole exome) targeting 39 million base pairs (39 Mb) of the human genome from patient tumor and matched normal sample (tumor-normal).

TMB is reported through both the total number of somatic non-synonymous exonic variants within the genes surveyed, as well as through an estimate of mutation rate by counting all somatic, synonymous and non-synonymous variants detected in gene coding regions and dividing by the approximate size of the whole exome.

The result, according to NantHealth, is a true determination of overall TMB, rather than the more common formulaic extrapolation of TMB from gene panel sequencing.

“We believe that this comprehensive diagnostic will provide greater accuracy than the widely-used formulaic extrapolation of TMB from a limited gene panel sequence,” NantHealth Chairman and CEO Patrick Soon-Shiong, MD, said in a statement. “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 tumors could benefit from checkpoint inhibitors and immunotherapy.”

By analyzing the breadth of a whole exome, many more neoepitopes and novel targets may be identified to support vaccine development, novel drug development, and therapies for previously undruggable targets, according to Sandeep Bobby Reddy, MD, NantHealth’s Chief Medical Officer.

“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,” Reddy stated. “Omics Core is the first whole exome test for TMB authorized by the FDA, and as such, marks a watershed moment in oncology.”

Headquartered in Culver City, CA, NantHealth last week has decreased its net loss during the third quarter and the first nine months of this year. The company finished Q3 with a net loss of about $16.377 million, down from a $97.464 million net loss in the year-ago quarter. For the first nine months of 2019, NantHealth reported a net loss of $51.013 million, compared with a $143.03 million net loss in January-September 2018.

NantHealth’s total net revenue edged up 0.3% to $22.356 million in Q3 from $22.292 million a year earlier. For January-September 2019, the company reported $71.771 million in total net revenue, up 7.8% from $66.603 million in the first three quarters of last year.

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