Rheonix COVID-19™ MDx Assay Receives Expanded FDA Emergency Use Authorization to Include Saliva Home Collection Kit
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 to include home collection using the Rheonix Laboratories COVID-19 PCR Test Saliva Home Collection Kit. Rheonix’s fully automated sample-to-answer COVID-19 assay received its initial EUA… Read More »
Rheonix Laboratories LLC is a New York State-permitted CLIA laboratory that provides easy, streamlined testing for organizations and community members
ITHACA, N.Y. — Rheonix Inc., a manufacturer of a highly advanced microfluidic molecular testing platform, announced the opening of Rheonix Laboratories LLC, a CLIA-certified clinical laboratory located in Ithaca, New York. Rheonix Laboratories is permitted by New York State to provide COVID-19 PCR testing and results, and will be partnering with… Read More »
Fully automated, scalable Rheonix method shows robust detection of variants
ITHACA, N.Y. — Rheonix Inc. today announced that the Rheonix COVID-19™ MDx Assay will detect the newly emerging omicron variant of SARS-CoV-2, as well as other variants of public health concern. The company’s assessments indicate that its COVID-19 MDx Assay detects all SARS-CoV-2 variants of concern and variants being monitored by the World Health Organization (WHO) and U.S. Centers for Disease… Read More »
ITHACA, N.Y. — Rheonix Inc. today announced the appointment of Roy Proujansky, M.D., and Irving Nachamkin, DrPH, MPH, to its board of directors.
"I'm honored to welcome Drs. Proujansky and Nachamkin to our board," said Greg Galvin, Ph.D., founder and CEO of Rheonix. "They join Rheonix at an exciting time as we provide critical testing solutions to address the pandemic and broaden our clinical diagnostic portfolio. The addition of these directors complements… Read More »
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 »
• 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 »