The RP2 Panel is a multiplex or syndromic test that enables to screen respiratory infections such as Covid-19, flu, bronchitis and the common cold
GenMark Diagnostics has secured FDA EUA status for ePlex RP2 test. (Credit: Belova59 from Pixabay)
GenMark Diagnostics has secured emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its ePlex respiratory pathogen panel 2 (RP2) test.
The RP2 Panel, a multiplex or syndromic test, offers results for over 20 viruses and bacteria that cause common and serious respiratory infections such as Covid-19, flu, bronchitis and the common cold.
GenMark’s test delivers rapid results for infections with similar symptoms such as fever, cough and body aches, thereby helping to minimise the ongoing risk of Covid-19.
The RP2 Panel delivers a new and simplified workflow for labs to efficiently run the test. Integrating Covid-19 into the existing ePlex respiratory pathogen (RP) panel is said to streamline the diagnostic process for hospitals by enabling them to check for multiple pathogens with a single test.
GenMark has designed the ePlex RP2 Panel to use with its ePlex system, ePlex RP panel and blood culture identification (BCID) panels, which were cleared by the FDA and secured CE mark approval.
GenMark already secured CE mark approval for the ePlex RP2 test
In September this year, GenMark Diagnostics secured CE mark approval for the ePlex respiratory RP2 test.
GenMark president and CEO Scott Mendel said: “Covid-19 is placing a spotlight on the importance of fast, comprehensive molecular testing.
“While we can’t predict what cold and flu season is going to look like this year, we know that we have to arm healthcare providers with the necessary tools to quickly and accurately diagnose the cause of infections in seriously ill patients, so syndromic testing is going to be critical.”
In March this year, GenMark secured EUA status for its ePlex SARS-CoV-2 test. The ePlex system is suitable for use in a range of hospital and reference lab settings.