The Swedish firm Biovica said this and additional studies will form the basis of a US Food and Drug Administration submission for its test measuring thymidine kinase-1.
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 authorization implements regulatory strategies the FDA advanced with industry stakeholders, though labs may still be more inclined to take the CLIA route, as long as it is available.
