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FDA Emergency Use Authorization for Rheonix SARS-CoV-2 Assay Expanded to Include Saliva Samples

NEW YORK – Molecular diagnostics instrument and assay maker Rheonix has received an expanded Emergency Use Authorization from the US Food and Drug Administration for its SARS-CoV-2 assay. The firm's test is now authorized for the use of saliva samples.

Ithaca, New York-based Rheonix obtained its initial EUA for a SARS-Cov-2 test in April.

The endpoint RT-PCR test, called the Rheonix COVID-19 MDx Assay, had been authorized for respiratory samples, including nasopharyngeal, oropharyngeal, anterior nasal, and mid-turbinate nasal swabs, nasal washes and aspirates, and bronchoalveolar lavage samples.

It is now authorized for use with saliva specimens collected without preservatives in a sterile tube in a healthcare setting. 

"Our customers are excited about the addition of this sample type, which will help them conserve precious laboratory resources," said Richard Montagna, Rheonix's senior vice president for scientific and clinical affairs, in a statement. "We are continuing to expand our COVID-19 tests to help address their ongoing COVID-19 testing challenges," he added.

The Rheonix test runs on the firm's fully automated sample-to-answer system called the Encompass MDx workstation, which the firm said requires minimal training to use, provides same-day results, and is highly scalable, "enabling laboratories to move from outsourcing their COVID-19 testing to providing same- or next-day test results for their communities or regions," Rheonix said.