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Home » Business, Policy & Funding » Regulatory News & FDA Approvals » FDA Clears NantHealth Tumor-Normal Whole-Exome Test

FDA Clears NantHealth Tumor-Normal Whole-Exome Test

Nov 12, 2019
|
staff reporter

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.

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