FDA Authorizes Respiratory Infection Panel for COVID-19, Flu Testing

The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to respiratory pathogen panel test which differentiates between 20 different respiratory infections, including coronavirus 2019 (COVID-19) and influenza (flu), within 2 hours.

The EUA, granted to GenMark Diagnostics for its ePlex Respiratory Pathogen Panel 2 (RP2), will allow clinicians to receive rapid molecular test results for both common and severe respiratory infections just in time for the beginning of the first flu season adjacent to the COVID-19 pandemic.

The RP2 panel, previously approved for clinical diagnosis in the European market last month, incorporated result capability for COVID-19 for its single-test assessment of multiple pathogens from patients.

A study conducted at a pair of large tertiary care hospitals indicated use of the panel in an emergency department (ED) resulted in earlier patient results and was associated with an 8.4% reduction in hospital admissions.

“COVID-19 is placing a spotlight on the importance of fast, comprehensive molecular testing,” Scott Mendel, president and chief executive officer of GenMark, said in a statement. “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.”

As some patients with COVID-19 have been observed with coinfection, the identification of infection causes is critical—as is the detection of sepsis, a life-threatening complication reported among some patients hospitalized with the pandemic virus.

Aside from providing rapid results which can identify or rule out responsible pathogens, the panel may provide clinicians better guidance in treatment strategies, and reduce the use of antibiotics.