NantHealth Announces FDA Marketing Authorization of Omics Core℠: The Nation’s First Tumor-Normal Mutation Profiling of Overall Tumor Mutational Burden from Whole Exome Sequencing in Solid Tumors
FDAclearance of whole exome sequencing in vitro diagnostic (IVD) test reporting overall tumor mutation burden (TMB) 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), for true determination of overall TMB, rather than the commonly-used formulaic extrapolation of TMB from gene panel sequencing.
- TMB, the measure of all acquired gene-coding mutations in a tumor genome, is an emerging biomarker predicting response to checkpoint therapy and identifies tumors that may benefit from immunotherapy.
- Omics Core additionally reports somatic mutations in 468 cancer-relevant genes accurate to 2% allele frequency providing a means to guide physician treatment decisions.
The Omics Core assay is the nation’s first
TMB is reported via two metrics:
- Total number of somatic non-synonymous exonic variants within the 19,396 genes (whole exome) surveyed.
- 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.
“Tumor mutation burden (TMB) is now recognized as a key biomarker across multiple tumor types. Studies have shown that immunotherapy treated patients with high TMB had better outcomes compared to those with low TMB. 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,“ said
“Omics Core is the first whole exome test for TMB authorized by the
“Multiple groups, including our own presentation at
“Determining the tumor mutational burden from whole exome sequencing is the first step in defining neoepitopes. These unique tumor mutations are recognized by T cells and elicit an immunological anti-tumor response. Patients with high TMB typically have more neoepitopes that attract cancer killing T cells to the tumor microenvironment. Identifying neoepitopes from whole exome TMB enables the development of neoepitope-targeted vaccines for the >95% of protein-encoding genes not covered by limited gene panel tests and the >99% of genes not directly targeted by drugs today. The clearance of Omics Core based upon its analytical performance and validity in reporting TMB establishes a new chapter in the era of precision cancer immunotherapy,” said
About Omics Core
The Omics Core assay is a qualitative in vitro diagnostic test that uses targeted next generation sequencing of formalin-fixed paraffin-embedded tumor tissue matched with normal specimens from patients with solid malignant neoplasms to detect tumor gene alterations in a broad multi gene panel. The test is intended to provide information on somatic mutations (point mutations and small insertions and deletions) and tumor mutational burden (TMB) for use by qualified health care professionals in accordance with professional guidelines, and is not conclusive or prescriptive for labeled use of any specific therapeutic product. Omics Core is a single-site assay performed at
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