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December 8, 2020

Rheonix obtains expanded EUA from FDA for Covid-19 assay

Molecular diagnostics instrument and assay maker Rheonix has received an expanded emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its SARS-CoV-2 assay.

Molecular diagnostics instrument and assay maker Rheonix has received an expanded emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its SARS-CoV-2 assay.

According to the amended EUA, the Rheonix COVID-19 MDx Assay can also be used with saliva specimens collected without preservatives in a sterile tube in a healthcare setting from people suspected of having Covid-19.

In April, the automated sample-to-answer assay received EUA for use on different respiratory specimens.

The endpoint RT-PCR test has been authorised for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal, oropharyngeal, anterior nasal, mid-turbinate nasal swabs, nasal washes, nasal aspirates, and bronchoalveolar lavage fluid.

The use of saliva samples will make the sample collection process easy and streamline the testing workflow.

It will also reduce the chances of medical personnel being exposed to potentially infected people.

The method serves as a better alternative for patients against invasive nasopharyngeal swabs.

Moreover, saliva sample type helps to ease critical supply chain issues by eradicating the need for specialised swab or collection devices.

Rheonix scientific and clinical affairs senior vice-president Richard Montagna said: “We’d like to thank our colleagues at the Cayuga Medical Center in Ithaca, New York, and Catholic Health System in Buffalo, New York, for their wonderful help in validating the use of saliva.

“Our customers are excited about the addition of this sample type, which will help them conserve precious laboratory resources.”

The test runs on the fully automated Rheonix Encompass MDx workstation, leveraging Rheonix CARD cartridge technology, and can be installed in critical locations of urgent need.

Rheonix COVID-19 MDx Assay also needs minimal training to use, delivers same-day results, and is highly scalable.

In addition, the test enables labs to move from outsourcing their testing to providing results on the same day or the next day for their communities or regions, Rheonix noted.

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