NEW YORK – The US Food and Drug Administration has granted 510(k) clearance to NantHealth for its Omics Core technology, a whole-exome tumor-normal in vitro diagnostic that measures overall tumor mutational burden in cancer tissue and reports somatic mutations in 468 cancer-relevant genes.
The Culver City, California-based company has said for the better part of a year that it would not be able to reach profitability without solving the "reimbursement conundrum" associated with these assays. In a conference call following the release of NantHealth's third quarter financial results last week CFO Bob Petrou said that FDA clearance for the tests would open the door to much-needed payor reimbursement.
NantHealth predicated its FDA submission on Memorial Sloan Kettering Cancer Center's MSK-IMPACT next-generation sequencing assay. However, this Omics Core offering differs from the MSK-IMPACT 468-gene panel in that it sequences the entire human exome and offers information about tumor mutational burden.
The company said that this is the first FDA marketing clearance of a WES test for tumor mutational burden.
Reporting of tumor mutational burden is based on both the total number of somatic nonsynonymous exonic variants in the whole exome and by estimating mutation rate by counting all somatic, synonymous, and nonsynonymous variants detected in gene coding regions, then dividing by the approximate size of the whole exome, NantHealth said.
"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," CMO Sandeep Reddy said in a statement. "Also, the breadth of a whole exome means that many more neoepitopes and novel targets may be identified to support vaccine development, novel drug development, and therapies for previously undruggable targets."
NantHealth also said that the Omics Core bundle reports on the same 468 cancer-relevant genes as the MSK test down to 2 percent allele frequency to help guide physician decisions for cancer therapies.
The company's stock price jumped 10 percent on Tuesday, closing at $.77.