Rheonix COVID-19 MDx assay will help detect SARS-CoV-2 novel coronavirus directly from respiratory samples
Rheonix has secured FDA EUA status for fully automated molecular COVID-19 test. (Credit: Thor Deichmann from Pixabay)
Rheonix has secured emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its rapid and full automated molecular COVID-19 test.
Rheonix COVID-19 MDx assay has been designed to identify SARS-CoV-2 novel coronavirus directly from respiratory samples.
The fully automated test, which will run on the Rheonix Encompass MDx workstation, will allow generating same-day test results for small and medium-throughput laboratories.
Rheonix COVID-19 MDx assay is a sample-to-answer test
Rheonix COVID-19 MDx assay is a sample-to-answer test, which helps to avoid taking the help of technician after loading the samples onto the workstation.
The system allows cost-effective on-site testing at distributed locations, enabling to take quick decisions on isolation and treatment for infected patients.
Rheonix has started supplying workstation and test kits to local and regional hospital laboratories for immediate commencement of testing.
The rapid test is said to be processed on the fully automated Rheonix Encompass MDx workstation by applying Rheonix Encompass CARD cartridge technology.
The system, which can be quickly installed in critical locations, is suitable for use in low to medium-throughput labs to provide same-day results for local and regional health networks, institutional facilities, and rural hospitals.
Rheonix COVID-19 MDx Assay is an endpoint RT-PCR assay designed to facilitate qualitative detection of nucleic acid from SARS-CoV-2 in respiratory samples from individuals who are suspected of COVID-19 by their healthcare provider.
In March, Rheonix commenced developing a fully-automated COVID-19 test kit employing its Encompass MDx workstation.
Rheonix scientific and clinical affairs senior vice president Dr Richard Montagna said: “Rapid diagnosis is critical in efforts to control the SARS-CoV-2 virus.
“We at Rheonix are grateful to the people on the front lines fighting the spread of the COVID-19 illness, and are proud to be able to support them with a rapid, accurate and automated tool to assist in their efforts.”