BioWorld MedTech
By Meg Bryant

Nanthealth Inc. has received U.S. FDA clearance for a whole exome sequencing test to determine overall tumor mutational burden (TMB) in cancer tissue. Known as Omics Core, the first-of-its-kind in vitro diagnostic test is available now as part of Nanthealth’s GPS Cancer molecular profiling suite.

Omics Core reports a cancer patient’s overall TMB by sequencing and comparing 19,396 protein-coding genes targeting 39 million base pairs of the human genome from a tumor sample and a normal sample, typically from blood or mucosal membrane. TMB indicates the sum of all acquired gene-coding mutations in a tumor genome and is increasingly used to predict response to therapy and identify tumors that could benefit from immunotherapy. In addition, the test reports somatic mutations in 468 cancer-relevant genes accurate to 2% allele frequency, to inform clinical decisions about patient treatment.

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