Rheonix COVID-19™ MDx Assay Receives Expanded FDA Emergency Use Authorization to Include Saliva as a Sample Type

ITHACA, N.Y. — Rheonix Inc. announced today that the United States Food and Drug Administration (FDA) has issued an expanded Emergency Use Authorization (EUA) for the Rheonix COVID-19™ MDx Assay and now allows the use of saliva as an approved sample type. The fully automated sample-to-answer assay was initially authorized for use on a range of respiratory specimens under EUA on April 29, 2020.   The ability to test saliva samples for the… Read More »

Rheonix Inc. Receives FDA Emergency Use Authorization for Rapid, Fully Automated Molecular COVID-19 Test

• Sample-to-answer method will enable rapid testing in distributed locations • Rheonix has begun shipments to laboratories under Emergency Use Authorization ITHACA, N.Y. — Rheonix Inc. announced today that it has received Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA) for the Rheonix COVID-19TM MDx Assay. The fully automated test enables detection of SARS-CoV-2, the virus that causes COVID-19, directly from respiratory samples. The test is designed to operate on… Read More »

Rheonix Inc. to Launch Rapid, Fully Automated Coronavirus Disease 2019 (COVID-19) Assay

Assay to provide small and medium-sized labs access to fast, cost-effective, sample-to-answer testing for public health threat ITHACA, N.Y. — Rheonix Inc., a leader in highly automated molecular diagnostics, today announced it is developing a coronavirus (COVID-19) test kit for use on its Encompass MDx® workstation. Upon Rheonix’s receipt of emergency use authorization (EUA) from the Food and Drug Administration (FDA), the new test will allow for the fully automated detection… Read More »