Beckman Coulter announces May launch of its SARS-CoV-2 serology test and ramps production to deliver over 30 million tests per month

BREA, CALIF., April 22, 2020 — Building on its strong commitment to the fight against coronavirus (COVID-19), Beckman Coulter today announced a mid-May launch timeline for its new Access SARS-CoV-2 IgG serology test and plans to achieve market-leading production volumes that will ramp to more than 30 million tests per month.

“The team at Beckman Coulter has been laser focused on developing new serology assays with the highest level of quality,” said Julie Sawyer Montgomery, president of Beckman Coulter. “We recognize the importance of getting the new Access SARS-CoV-2 IgG test into the hands of frontline medical personnel as soon as possible. We plan to deliver more than one million tests in the first week of launch and have the manufacturing capability to deliver 100% of our U.S. customer’s weekly testing needs by late June, with additional capacity available to meet the demand of our global customers. Keeping with FDA guidance, the new IgG test will be introduced following rigorous in-house validation and submission for EUA authorization, and we will submit for CE Mark certification in the near future.”

The availability of the Access SARS-CoV-2 IgG assay will enable healthcare professionals to expedite patient testing utilizing a large installed base of existing DxI immunoassay analyzer and Access 2 immunoassay analyzers with testing on the DxCi platform to be available shortly thereafter. Beckman Coulter’s immunoassay analyzers are used in both the hospital core laboratory and smaller laboratories and can deliver up to 200 serology test results per analyzer per hour, depending upon the analyzer. This is important as up until now, many hospitals have had to rely upon lateral flow serology testing, which may have significantly lower sensitivity and specificity.

“The ability to deliver rapid test turnaround times with high quality is increasingly important as the market better understands the connection between sensitivity, specificity, disease prevalence rates and the implications on false-positive results,” said Kathleen Orland, senior vice president and general manager of Beckman Coulter’s Clinical Chemistry and Immunoassay business.

This is the first of Beckman Coulter’s Access SARS-CoV-2 serology assays and the company will continue to work with the FDA and global healthcare leaders to bring additional serology assays to the market to help combat COVID-19.