In the long term, the company is developing a plan to create more tests based on its technology, which digitizes blood samples and turns them into images.
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.
In one of two clearances in October, DiaSorin got the nod to market its Liaison XL Zika Capture IgM II test for the detection of Zika virus IgM antibodies.
Hardy Diagnostics has partnered with NG Biotech to exclusively distribute the 15-minute test in the US. It has also brought it through the US regulatory process.
