Rheonix receives FDA clearance for workstation and molecular test for STIs

Jan. 11, 2022

Rheonix announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its automated Encompass MDx Workstation, along with its STI TriPlex Assay and Male Urine Collection Kit for the detection of sexually transmitted infections (STI).

The fully automated Encompass MDx workstation enables multiplexed sample-to-answer detection, simplifying laboratory workflows and reducing the burden on laboratory technicians.

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 said it will seek FDA approval for additional syndromic diagnostic panels 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.

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