NEW YORK – Rheonix said on Thursday that it has received Emergency Use Authorization from the US Food and Drug Administration for the Rheonix COVID-19 MDx assay.
The endpoint RT-PCR test is processed on the company's Encompass CARD cartridge, which runs on Rheonix's Encompass MDx workstation. It is intended for the qualitative detection of nucleic acid from SARS-CoV-2 in respiratory samples from individuals suspected by their healthcare provider of having COVID-19.
Rheonix said that the assay is fully automated and can provide same-day results for low- and medium-throughput laboratories. The company said that it has begun shipping the workstation and test kits to high-need local and regional hospital laboratories to enable them to begin testing immediately.
Ithaca, NY-based Rheonix is currently seeking full FDA clearance for the Encompass workstation and a triplex sexually transmitted infection assay to simultaneously detect nucleic acid from Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis from patient samples.