510(k)

The Ithaca, New York-based firm has submitted its molecular diagnostic instrument along with a test to detect chlamydia, gonorrhea, and trichomonas.

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 FDA clearance follows earlier US marketing approval for the firm's C. Difficile assay.

The test detects 20 common viruses and bacteria that cause upper respiratory infections using the firm's high-throughput, automated MDx-3000 instrument.

Applied BioCode said that it now has access to higher volume laboratories that use the Roche MagNa Pure 96 System for sample extraction.

Akonni has received clearance for a molecular diagnostic instrument and a saliva-based pharmacogenomics test for warfarin metabolism.

The in vitro diagnostic is designed to detect whole gene segments for influenza A and B viruses and can characterize viruses as seasonal or nonseasonal.

The test completes a suite of assays designed to detect pathogens that can cause sepsis using the firm's ePlex system.

The firm had also applied for marketing clearance for its gram negative and fungal pathogen panels in October.

The enteric panel detects the viral cause of infectious diarrhea symptoms including norovirus, rotavirus, adenovirus, human astrovirus, and sapovirus.