The test detects 20 common viruses and bacteria that cause upper respiratory infections using the firm's high-throughput, automated MDx-3000 instrument.
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.
The Carlsbad, California-based molecular diagnostics firms reported $18.4 million in revenues, up from 14.9 million in Q2 of 2018.
The firm has three clinical trials in progress to validate the clinical utility of products it soon intends to submit for regulatory clearances to the FDA.
It placed 39 net new ePlex analyzers, expanding the global installed base to 393 placements and growing its installed base by 72 percent compared to the prior-year period.
The submission by Curetis' distribution partner Beijing Clear Biotech used data previously collected for regulatory approvals in the US and Europe.
The deal covers distribution of the SpeeDx ResistancePlus and PlexPCR assays.
New funding will support assay development and lab space to offer test services, and ultimately a test kit using the firm's resistance database.
Its most advanced gene expression signatures are for infectious disease diagnostics and are aimed at enabling the appropriate prescription of antiviral and antibiotic medications.
Despite a recent positive economic modeling study, the debate over appropriate use of the ME panel seems likely to continue until more outcomes studies are conducted.
NPR says the explosion and fire earlier this week at a Russian lab that stores dangerous pathogens revives the question of whether such samples should be kept.
According to Wired, Nebula Genomics is providing a way for people to get their genomes sequenced anonymously.
A 26-year-old woman tells Cosmopolitan about learning her APOE status at a young age.
In Science journals this week: a functional genomic screen uncovers drug combination that increases KRAS inhibitor efficacy in aggressive lung cancer, and more.