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COVID-19 RT-PCR Test Receives FDA Emergency Use Authorization
WALTHAM, Mass. – June 15, 2020 – PerkinElmer, Inc., a global leader committed to innovating for a healthier world, announced today that EUROIMMUN, a PerkinElmer Company, has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its EURORealTime SARS-CoV-2 assay. Clinical laboratories certified under Clinical Laboratory Improvement Amendments (CLIA) to perform high complexity tests can immediately begin using this RT-PCR test to detect SARS-CoV-2, the virus that causes COVID-19.
HOW IT WORKS: This assay, which also received CE mark in Europe, is authorized for use with upper respiratory specimens collected from individuals suspected by their health care provider to have COVID-19. PerkinElmer now offers three FDA EUA solutions for COVID-19: the EURORealTime SARS-CoV-2 assay, the PerkinElmer Coronavirus Nucleic Acid Detection Kit and EUROIMMUN’s Anti-SARS-CoV-2 ELISA (IgG) serology test.
WHY: “Since the onset of this pandemic, PerkinElmer has been working diligently to support laboratories across the U.S. and globally by offering RT-PCR and serology assays for COVID-19 testing,” said Hamid Erfanian, chief executive officer, EUROIMMUN U.S. “This latest EUA further bolsters our SARS-COV-2 detection offerings. PerkinElmer’s RT-PCR and serological testing solutions will help more customers continue to battle the pandemic.”
MORE: Enabling science is vital in the fight against COVID-19. PerkinElmer is actively working with its global customers – which include specialty and reference diagnostic laboratories, clinics, hospitals, pharmaceutical and biopharmaceutical laboratories, academia, and governmental and research institutes – to combat the pandemic. The Company’s innovative detection, workflow, and research solutions are being used to drive better outcomes as the world responds to COVID-19.
PerkinElmer’s comprehensive SARS-COV-2 offerings span RT-PCR, high throughput RNA extraction, automation, ELISA and lateral flow-based serology testing.
The company’s latest FDA EUA solution broadens RT-PCR and serology offerings available in the U.S.