FDA gives Rheonix COVID-19 testing procedure emergency-use authorization

ITHACA, N.Y. — Rheonix Inc. of Ithaca on Monday announced that the U.S. Food & Drug Administration (FDA) has issued an expanded emergency-use authorization (EUA) for the Rheonix COVID-19 MDx assay, allowing the use of saliva as an approved sample type.

An assay is an investigative procedure in laboratory medicine for assessing or measuring the presence, amount, or activity of a target entity.

The “fully automated,” sample-to-answer assay on April 29 was initially authorized for use on a range of respiratory specimens under an EUA, per a company news release.

The ability to test saliva samples for the presence of the coronavirus (SARS-CoV-2), the virus that causes COVID-19, “simplifies” the sample-collection process and “streamlines” the testing workflow, while reducing the exposure of medical personnel to potentially infected individuals, Rheonix said.

For patients, this less invasive sample-collection method is a “welcome alternative” to nasopharyngeal (NP) swabs, the “most prevalent” sample type. In addition, use of saliva as a sample type “helps to ease critical supply chain issues” by eliminating the need for specialized swab or collection devices, Rheonix contends.

The company’s COVID-19 MDx assay is processed on the Rheonix Encompass MDx workstation using proprietary Rheonix CARD cartridge technology, per its release. The system requires minimal training to use and “can be quickly installed in critical locations of immediate need,” the firm said.

It 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.

About emergency use authorization status

The Rheonix COVID-19 MDx assay is intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swabs; oropharyngeal (throat) swabs; anterior nasal swabs; mid-turbinate nasal swabs; nasal washes; nasal aspirates; and bronchoalveolar lavage (BAL) fluid from individuals who are suspected of COVID-19 by their health-care provider.

Under the amended EUA, the Rheonix COVID-19 MDx assay is also for use with saliva specimens collected without preservatives in a sterile tube in a health-care setting from individuals who are suspected of COVID-19 by their health-care provider.

The Rheonix COVID-19 MDx assay has not been FDA cleared or approved, Rheonix notes. This test has been authorized by FDA under an EUA for use by authorized laboratories.

This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19.