The FDA has been prodding labs performing pharmacogenetic testing, and software firms providing reports from such testing, to undergo regulatory review.
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 test detects 20 common viruses and bacteria that cause upper respiratory infections using the firm's high-throughput, automated MDx-3000 instrument.
Florida Politics reports Florida's law barring life, long-term care, and disability insurers from using genetic information in coverage decisions went into effect at the beginning of July.
