PerkinElmer has announced today that the U.S. Food and Drug Administration (FDA) has provided Emergency Use Authorization (EUA) for the Company’s New Coronavirus RT-PCR test.
“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.”
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. 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.
FDA has also announced that it has responded to the COVID-19 pandemic by facilitating medical countermeasures to treat and prevent the disease and surveilling the medical product and food supply chains for potential shortages or disruptions and helping to mitigate impacts.
"President Trump's aggressive response and bold actions to keep Americans safe from COVID-19 bought us precious time to advance therapeutics and other necessary tools," said HHS Secretary Alex Azar.
President Trump has directed the FDA to continue its work with the public and private sector to provide safe and effective drugs to patients, including those infected with COVID-19. The FDA has been working closely with other government agencies and academic centers that have investigated the use of the drug chloroquine to determine whether it can be used to treat patients with mild-to-moderate COVID-19.
If the drug is approved, it could potentially reduce the duration of symptoms, as well as viral shedding, which can help prevent the spread of disease. Studies are underway to determine the efficacy in using chloroquine to treat 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.