Roche’s Elecsys Anti-SARS-CoV-2 serology test nearing launch

Roche is currently developing its Elecsys® Anti-SARS-CoV-2 serology test to identify antibodies in people previously exposed to the Severe Acute Respiratory Syndrome Coronavirus 2 that causes the COVID-19 disease, and hopes to be in a position to launch the in vitro test by early May in countries accepting the CE mark. The immunoassay test uses plasma and human serum drawn from a blood sample to ascertain the body’s immune reaction to SARS-CoV-2. Roche proposes to significantly increase monthly production of the tests by June and is planning to still further increase production as quickly as they possibly can and is also in negotiations with the FDA for an Emergency Use Authorisation in the USA.

Roche Diagnostics chief executive officer, Thomas Schinecker, said: “Roche is deeply committed to supporting the global response to the COVID-19 pandemic. Timely availability and fast access to reliable, high quality tests are essential for healthcare systems. The antibody test is an important next step in the fight against COVID-19. Roche’s antibody test can be quickly scaled and made broadly available around the world as our instrument infrastructure is already in place.”

Roche Group chief executive officer, Severin Schwan, said: “Following the launch of our high-volume PCR test in mid-March to detect active infection of the disease, we are now going to launch a new antibody test in early May. Every reliable test on the market serves its purpose for healthcare systems to help us overcome this pandemic. Roche is collaborating closely with health authorities and ramping up production to ensure fast availability of the test globally.”