The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to MatMaCorp’s Covid-19 2SF RNA test for SARS-CoV-2 detection on its Solas 8 portable detection system.
The RT-PCR test can identify the SARS-CoV-2 genetic material from nasopharyngeal swab samples collected from Covid-19 suspected patients.
It is approved under EUA for use in labs that are CLIA-certified to carry out high-complexity testing.
The platform can perform multiple RT-PCR assays quickly and is validated by six independent locations across the US.
MatMaCorp had received the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) initiative funding to expand Covid-19 testing in rural and agricultural communities.
MatMaCorp founder and president Dr Abe Oommen said: “As a diagnostics company founded and headquartered in Nebraska, we are committed to serving our rural and agricultural communities.
“With the financial support and regulatory guidance from NIH and the RADx initiative, and now, with FDA emergency use authorisation, we can help increase Covid-19 testing for our underserved communities that feel left behind.”
In a separate development, Ortho Clinical Diagnostics also received EUA from the FDA for its VITROS SARS-CoV-2 Antigen Test for detecting active Covid-19 infection.
The Covid-19 test can run up to 130 tests in an hour and could be used for mass-scale testing and delivering same-day results.
The VITROS SARS-CoV-2 Antigen Test delivers precise, clinically reliable results on the company’s high-volume VITROS Systems, which are installed in more than 5,600 labs across the world.
The company noted that it is currently capable of delivering five million tests a month and can increase to 15 million tests a month by February.
Last November, the test received CE Mark.
In the same month, the company initiated the distribution of the tests in the US, following the FDA’s emergency use notification (EUN).