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 »
New addition to Rheonix leadership adds expertise in infectious diseases and global epidemic response
ITHACA, N.Y. — Rheonix Inc., an innovative leader in highly multiplexed pathogen detection, announced the appointment of Stephen J. Thomas, M.D., as Chief Medical Officer and member of the Rheonix Board of Directors.
"I am delighted to welcome Dr. Thomas to the Rheonix Board and as our Chief Medical Officer," said Greg Galvin, President, CEO and Chairman of… Read More »
Low-cost, scalable, sample-to-answer system provides flexibility and true walk-away testing
ITHACA, N.Y. — Rheonix Inc., an innovative leader in highly multiplexed pathogen detection, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance of its automated Encompass MDx® Workstation, 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… 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 »
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 »
ITHACA, N.Y. — Rheonix, Inc. Rheonix filed its first 510(k) on November 4, seeking to gain FDA clearance of its Rheonix STI TriPlex™ Assay (a PCR-based assay for the simultaneous detection for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis) as well as the Rheonix Encompass MDx® Workstation, a fully automated “sample-to-answer” system capable of taking untreated clinical specimens and extracting, purifying and PCR amplifying DNA targets. In addition the 510(k) filing… Read More »