PerkinElmer’s New Nucleic Acid Detection Kit for SARS-CoV-2 Secures FDA EUA Approval

By LabMedica International staff writers
Posted on 30 Mar 2020

PerkinElmer, Inc. (Waltham, MA; USA) has received Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA) for its new Coronavirus RT-PCR test. Clinical laboratories certified under Clinical Laboratory Improvement Amendments (CLIA) can immediately begin using this kit to detect SARS-CoV-2, the virus that causes COVID-19.

PerkinElmer enables scientists, researchers and clinicians to address their most critical challenges across science and healthcare. With a mission focused on innovating for a healthier world, the company delivers unique solutions to serve the diagnostics, life sciences, food and applied markets. PerkinElmer’s RT-PCR test is marketed as an in vitro diagnostic (IVD) device by meeting the requirements of the European In Vitro Diagnostic Directive (IVDD) and is available in over 30 countries worldwide.

Image: PerkinElmer’s detection kit for SARS-CoV-2 (Photo courtesy of PerkinElmer, Inc.)

“Despite the challenging environment, our employees have demonstrated unwavering commitment over the past two months to combat this global pandemic,” said Prahlad Singh, president and chief executive officer, PerkinElmer. “The breadth of PerkinElmer’s total workflow solution puts us in a unique position to rapidly address the needs of our clinical diagnostics customers.”

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