Beckman Coulter Announces Development of Tests to Detect Coronavirus Antibodies
BREA, CALIF., March 31, 2020 — In response to the global COVID-19 pandemic, Beckman Coulter today announced that it is developing assays to identify IgM and IgG antibodies to the coronavirus or SARS-CoV-2. The assays will be designed for use on any of its high- throughput Access family of immunoassay systems, including the Access 2 and DxI series installed globally.
Research has shown that after infection with SARS-CoV-2, viral antigens stimulate the body's immune system to produce antibodies that can be detected with IgM and IgG tests. “Antibody assays play a critical role in understanding the measure of immunity an individual has developed against SARS-CoV-2,” said Kathleen Orland, senior vice president and general manager for Beckman Coulter's chemistry and immunoassay business. “This type of understanding could help determine the identification of those who would require a vaccine once available or when an infected individual could safely return to work.”
“With the ability to assess a patient's immunity to SARS-CoV-2, this testing modality may enable clinicians to clear hospital staff, emergency responders, and others to get back to work with an indication that have had prior exposure and therefore may have immunity to the disease,” said Shamiram R. Feinglass, M.D., MPH, chief medical officer, Beckman Coulter. “This test also could allow those without immunity to be identified and kept safe until the pandemic subsides.”
Once the assays are finalized, Beckman Coulter intends to follow FDA's Emergency Use Notification process as provided in the FDA's Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency (March 16, 2020).
For the latest information on the new assays, visit www.beckmancoulter.com/coronavirus
About Beckman Coulter
Beckman Coulter is committed to advancing healthcare for every person by applying the power of science, technology and the passion and creativity of our teams to enhance the diagnostic laboratory's role in improving healthcare outcomes. Our diagnostic systems are used in complex biomedical testing, and are found in hospitals, reference laboratories and physician office settings around the globe. Beckman Coulter offers a unique combination of people, processes and solutions designed to elevate the performance of clinical laboratories and healthcare networks. We do this by accelerating care with a menu that matters, bringing the benefit of automation to all, delivering greater insights through clinical informatics and unlocking hidden value through performance partnership. An operating company of Danaher Corporation since 2011, Beckman Coulter is headquartered in Brea, Calif., and has more than 11,000 global associates working diligently to make the world a healthier place.