Rheonix has received an expanded emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its COVID-19 MDx Assay.
The amended EUA now includes home collection using the Rheonix Laboratories COVID-19 PCR Test Saliva Home Collection Kit.
In April 2020, the company received the first EUA for its fully automated, sample-to-answer assay for use on various respiratory samples.
Subsequently, the EUA was expanded to include saliva as a sample type as well as use by moderate as well as high complexity laboratories.
Rheonix COVID-19 MDx Assay has been authorised to detect nucleic acid from SARS-CoV-2 in saliva samples self-collected by individuals aged 18 years and above, self-collected under adult supervision for individuals aged 14 years and above, or collected with adult assistance for those five years and above.
Rheonix Board of Directors chairman, CEO and president Greg Galvin said: “The addition of a home collection kit expands individuals’ access to a low-cost, highly sensitive Covid PCR test.
“We have confirmed our test’s ability to reliably detect the omicron subvariants, including BA.5.
“This is critical at a time when home antigen tests have been shown to be much less effective at detecting this highly infectious subvariant.”
The Covid-19 home collection kit will initially be offered through a New York State-permitted CLIA-compliant clinical laboratory, Rheonix Laboratories, located in Ithaca, New York.
Additionally, the company intends to expand the kit’s use through collaboration with other authorised laboratories.
In December 2020, Rheonix received an expanded FDA EUA for the COVID-19 MDx Assay.
This EUA was granted to allow the use of the assay with saliva specimens collected in a healthcare setting in a sterile tube without preservatives from people suspected of having Covid-19.