PerkinElmer (NYSE:PKI) announced that the FDA granted it emergency use authorization (EUA) for its new coronavirus RT-PCR test.
The Waltham, Mass.-based company said in a news release that clinical laboratories that are certified under the Clinical Laboratory Improvement Amendments (CLIA) can now immediately begin using the kit to detect the SARS-CoV-2 virus that causes COVID-19.
PerkinElmer said its RT-PCR test is marketed as an in vitro diagnostic device as well. It meets the requirements of the European In Vitro Diagnostic Directive and is available in over 30 countries worldwide.
“Despite the challenging environment, our employees have demonstrated unwavering commitment over the past two months to combat this global pandemic,” PerkinElmer president & CEO Prahlad Singh said in the news release. “The breadth of PerkinElmer’s total workflow solution puts us in a unique position to rapidly address the needs of our clinical diagnostics customers.”
Earlier this week, Danaher Corp. (NYSE:DHR) subsidiary Cepheid became the 13th company to get an FDA EUA nod for a coronavirus test, and PerkinElmer is another to add to the growing list of medtech companies lending a hand during the pandemic.