Beckman Coulter's SARS-CoV-2 IgG antibody test now available in markets accepting the CE Mark

Company has ramped manufacturing capacity to deliver 30 million tests per month

Serology test detects IgG antibodies targeting the receptor-binding domain of the spike protein and has confirmed 100% sensitivity and 99.8% specificity

Test helps identify donors of convalescent plasma in combatting second wave of infections

BREA, California, June 15, 2020 /PRNewswire/ -- Beckman Coulter today announced that its Access SARS-CoV-2 IgG assay is now available in markets accepting the CE Mark. The company has already shipped tests to more than 400 hospitals, clinics and diagnostics laboratories in the U.S. and has begun shipping to customers globally. Beckman Coulter has more than 16,000 immunoassay analyzers worldwide and has ramped its manufacturing to deliver more than 30 million tests a month.

Henry Ford Health System was one of the first health systems to receive Beckman Coulter's test and independently validate its performance.

"We selected the Beckman Coulter Access SARS-CoV-2 IgG antibody assay to be the backbone of Henry Ford's COVID-19 serology testing program because of its outstanding performance in our rigorous independent evaluation," said Dr. Bernard C Cook, Division Head of Chemistry-Pathology, Henry Ford Health System. "Henry Ford found when running the Beckman Coulter SARS-CoV-2 assay on 204 PCR-confirmed COVID-19 patient samples, a test sensitivity of 100% at 14 days post-PCR and testing of 80 patient samples from the pre-COVID era yielded a specificity of 100%."

The Beckman Coulter Access SARS-CoV-2 IgG assay detects immunoglobulin G (IgG), and targets antibodies that recognize the receptor-binding domain (RBD) of the spike protein which SARS-CoV-2 uses to bind to a human cell receptor. This is significant as antibodies that target the RBD have the potential to be neutralizing and thus prevent future infection by blocking the virus from entering the cell. It is for this reason many vaccine developers are also targeting the RBD of the spike protein in their vaccine development.¹

"Our assay has the potential to identify individuals who have already mounted an immune response to the novel coronavirus and could donate convalescent plasma for use in combatting the disease in seriously ill patients," said Julie Sawyer Montgomery, president of Beckman Coulter. "Convalescent plasma therapy will be a critical tool in our treatment arsenal in the absence of an effective vaccine as we look toward the fall and winter when many epidemiologists anticipate a second large wave of infections."

Many of Beckman Coulter's analyzers can deliver up to 400 routine tests an hour. A large number of analyzers are connected to hospital information systems, enabling laboratories to automate the reporting of serology test results. The Access SARS-CoV-2 IgG test can also be run on Beckman Coulter's Access 2 analyzer, a compact table-top analyzer enabling high-quality serology testing to be carried out in small hospitals and clinics. This test seamlessly integrates into laboratory workflows making it easy to add serology testing to routine blood tests performed during inpatient and wellness testing, so health systems can begin to comprehensively determine the immune status of their communities.

"An IgG antibody assay such as the test Beckman Coulter has developed can provide valuable information regarding community levels of immunity that will inform public health decision making and rollout of a vaccine when one does become available," said Shamiram R. Feinglass, M.D., MPH, chief medical officer Beckman Coulter. "The very high sensitivity and specificity of this assay provides a high positive predictive value, even when overall incidence of disease is low. Additionally, since our assay can be run on multiple different types of analyzers, it can be adapted to a variety of healthcare settings to best meet the needs of each community."

Beckman Coulter will continue to focus on bringing innovative tests to market, and will be seeking CE Mark for its Access SARS-CoV-2 IgM assay in the near future. For the latest information on the Access SARS-CoV-2 IgG assay, or for more information about Beckman Coulter's commitment to fight against COVID-19, visit: www.BeckmanCoulter.com/Coronavirus.

About the Access SARS-CoV-2 IgG Assay
The Access SARS-CoV-2 IgG Assay is a qualitative immunoassay that detects IgG antibodies directed to the receptor-binding domain of the spike protein of the novel coronavirus that is driving the ongoing global pandemic. It is believed that these antibodies have the potential to be neutralizing antibodies and may play a role in lasting immunity. The test has a confirmed 99.8% specificity and 100% sensitivity at 18 days post PCR confirmed positive test. The assay uses immobilized virus antigens on magnetic particles to capture IgG antibodies from patient serum or plasma samples and reveals them using labelled anti-IgG antibodies. The Access SARS-CoV-2 IgG assay can be used with a variety of Beckman Coulter analyzers, including the high-throughput DxI 800 designed for large labs, to the DxI 600 for mid-sized labs and the DxCi and Access 2 analyzers for smaller labs and healthcare clinics. The assay can be seamlessly integrated into existing workflows without batch processing.

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 (NYSE: DHR) since 2011, Beckman Coulter is headquartered in Brea, California, and has more than 11,000 global associates working diligently to make the world a healthier place.

¹ Grifoni, A., et al., Targets of T cell responses to SARS-CoV-2 coronavirus in humans with COVID-19 disease and unexposed individuals, Cell (2020), prepublication, doi: https://doi.org/10.1016/j.cell.2020.05.015

© 2020 Beckman Coulter. All rights reserved. Beckman Coulter, the stylized logo, and the Beckman Coulter product and service marks mentioned herein are trademarks or registered trademarks of Beckman Coulter, Inc. in the United States and other countries.

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