The U.S. Food and Drug Administration (FDA) has granted Rheonix — a provider in multiplexed pathogen detection — 510(k) clearance of its automated Encompass MDxWorkstation, along with its STI TriPlex Assay and Male Urine Collection Kit for the detection of sexually transmitted infections (STI).
“Rheonix is pleased to announce our FDA 510(k) approval for a diagnostic test kit and for our unique microfluidic workstation that provides true sample-to-answer automation in the clinical laboratory,” says Greg Galvin, PhD, founder and CEO of Rheonix. “Throughout the pandemic, the simplicity, flexibility and low cost of the Encompass workstations have enabled laboratories to provide scalable, same-day testing. We are excited to continue building on this platform with a menu of multiplexed panels.”
The fully automated Encompass MDx workstation enables multiplexed sample-to-answer detection, designed to simplify laboratory workflows and reduce the burden on laboratory technicians. The Rheonix Encompass MDx workstation has been used in combination with the Rheonix COVID-19MDx Assay under FDA emergency use authorization (EUA) to enable same-day COVID-19 testing in local and regional laboratories.
The Rheonix STI TriPlex Assay is approved for simultaneous detection and differentiation of Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis, three leading causes of sexually transmitted infection. The assay and collection device are approved for use in male urine samples. Rheonix will seek FDA approval for additional syndromic diagnostic panels that leverage the Encompass MDx workstation’s ability to perform simultaneous detection of multiple target organisms from a single clinical sample.
Assays in the Rheonix pipeline include a multiplexed test for simultaneous detection of respiratory pathogens including SARS-CoV-2, influenza and respiratory syncytial virus; a panel of leading organisms that cause gastrointestinal infection; and STI assays with expanded targets and sample types.
Featured image: Rheonix Encompass MDx workstation Photo: Rhoenix