PerkinElmer Receives FDA Emergency Use Authorization for EUROIMMUN COVID-19 RT-PCR Test
Company’s latest FDA EUA solution broadens RT-PCR and serology offerings available in the U.S.
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 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, we deliver unique solutions to serve the diagnostics, life sciences, food and applied markets. We strategically partner with customers to enable earlier and more accurate insights supported by deep market knowledge and technical expertise. Our dedicated team of about 13,000 employees worldwide is passionate about helping customers work to create healthier families, improve the quality of life, and sustain the wellbeing and longevity of people globally. The Company reported revenue of approximately $2.9 billion in 2019, serves customers in 190 countries, and is a component of the S&P 500 index. Additional information is available through 1-877-PKI-NYSE, or at www.perkinelmer.com.
# # #