Recent studies question the clinical utility of tumor mutational burden as a biomarker for immuno-oncology response, and the FDA clearance includes no therapeutic indications.
The approval of its Omics Core assay for tumor-normal mutational profiling opens the door for payor reimbursement, which is key to reaching profitability, NantHealth said.
The company announced this week the expansion of a genetic testing program for US patients with inherited retinal disease that it has run with partners since 2017.
The companies will use Foundation Medicine's FoundationOne CDx test as the baseline to define a set of unique variants that the codeveloped assays will monitor.
The firm did not disclose the size of the funding, which is helping it build on its Centrellis Health Intelligence Platform and move to whole-exome sequencing.
NantHealth's net loss fell by 37 percent, to $14.7 million, as revenue from software-related revenue jumped by 23 percent while expenses fell.
The national project has developed infrastructure for implementing genomics into clinical care and is now studying clinical utility and cost effectiveness.
The firms aim to combine PerkinElmer 's Ordered Data Interpretation Network and FDNA's Face2Gene facial analysis software to target emerging markets.
During an NIH meeting, researchers from four newborn sequencing research projects discussed results of their studies and future implications.
The new grant will be used to conduct whole-exome sequencing on 1,000 children participating in an autism spectrum disorder study for the purposes of biomarker development.