510(k)
23andMe Gains FDA Clearance for Direct-to-Consumer Prostate Cancer Genetic Risk Test
The firm is now authorized to sell a genetic health report on the HOXB13 marker that indicates risk for hereditary prostate cancer, its third DTC cancer risk report with 510(k) clearance.
NYU Langone Health Gets FDA Clearance for Solid Tumor Gene Sequencing Test
The test uses next-generation sequencing to detect cancer-linked mutations in 607 genes to help guide patient treatment.
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.
FDA Clears NantHealth Tumor-Normal Whole-Exome Test
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.