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# NantHealth Tumor Mutational Burden Assay Cleared
- URL: https://www.fdaweb.com/nanthealth-tumor-mutational-burden-assay-cleared/
- Published: 2019-11-13T12:00:00.000Z
- Updated: 2026-09-14T15:53:03.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145494

FDA has cleared a NantHealth 510(k) for its Omics Core, a whole exome tumor-normal *in vitro* diagnostic that measures overall tumor mutational burden (TMB) in cancer tissue. The company describes the assay as the first “custom-targeted whole exome sequencing platform to report both overall tumor mutation burden in tumor specimens from 19,396 protein-coding genes (whole exome) and somatic alterations (point mutations, small insertions and deletions) in 468 cancer-relevant genes.”  
  
The company says that 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,” it says. “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.”