The FDA approved FoundationOne CDx as a companion diagnostic for alpelisib in combination with fulvestrant to treat certain PIK3CA-mutated breast cancers.
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 blood test screens individual blood donations for four common species of the parasite Babesia, which can cause anemia and other potentially fatal conditions.
The clearance of the Binx io CT/NG test marks a milestone for the Johns Hopkins University group that funds early-stage development of rapid STI testing.
