On November 12, 2019, the FDA approved NantHealth's Omics Core, the first clinical genetic test based on whole exome sequencing (WES), for 510 (k) approval. It is also the first FDA-approved tumor mutation load (TMB) assay based on whole exome sequencing (WES).

Efficient database construction of complex and difficult clinical samples is a key factor in the success of Omics Core. It is worth mentioning that the Roche Diagnostic Kapa DNA Library Construction Kit is used as the library preparation technology for Omics Core.

• Omics Core is an in vitro, all-exon oncology diagnostic technology that detects the total tumor mutation load (TMB) in cancer tissue and somatic mutations in 468 cancer-related genes.

  NantHealth validated its Omics Core technology against Memorial Sloan Kettering Cancer Center's MSK-IMPACT genetic testing and analysis platform. However, Omics Core differs from msk-impact 468 gene-testing panel in its ability to sequence the entire human exome and provide information about tumor mutation load (TMB), reducing all allele frequencies to 2%, to help guide physicians in making accurate cancer treatment decisions.