Roche to launch laboratory SARS-CoV-2 antigen test to support high-volume testing of suspected COVID-19 patients

The Elecsys® SARS-CoV-2 Antigen test is an automated laboratory assay intended as an aid in the diagnosis of SARS-CoV-2 infectionThis new solution will run on all Roche cobas e immunochemistry analysers which are widely available around the world, thus helping to increase testing capacityIn combination with other COVID-19 diagnostic tests, the Elecsys SARS-CoV-2 Antigen test can help in the management of patients for optimal care delivery
Basel, 13 October 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it intends to launch a high-volume SARS-CoV-2 Antigen test as an aid in the diagnosis of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection. The test is planned to be made available at the end of 2020 for markets accepting the CE Mark. Roche also intends to file for Emergency Use Authorisation (EUA) from the U.S. Food and Drug Administration (FDA).*currently only available in CE marketsa high-volume molecular test to detect SARS-CoV-2, the virus that causes COVID-19, (FDA Emergency Use Authorisation (EUA) and available in countries accepting the CE Mark)a SARS-CoV-2 laboratory-based qualitative antibody test, aimed at detecting the presence of antibodies in the blood targeting the nucleocapsid protein (FDA EUA and CE Mark)an IL-6 test to assist in identifying severe inflammatory response in patients with confirmed COVID-19 (FDA EUA and CE Mark)Roche v-TAC, which could help simplify the screening, diagnosis and monitoring of patients with respiratory compromise in the current COVID-19 pandemica SARS-CoV-2 rapid antibody test to help determine at the point of care whether a person has been exposed to the virus (CE Mark)a rapid antigen test to support in the detection of SARS-CoV-2 at the point of care within 15 minutes (CE Mark)a high-volume molecular test to simultaneously detect and differentiate between SARS-CoV-2 and influenza A/B, as the symptoms are similar for both (FDA EUA and CE Mark)a second SARS-CoV-2 antibody test, aimed at measuring the spike protein to support vaccination development and complement our existing portfolio (CE Mark)Our research into therapies:
Roche is committed to improving the treatment of COVID-19. We are actively involved in understanding the potential of our existing portfolio and are exploring the potential of our investigational molecules.Roche Group Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com
Attachment13102020_MR_ Pre-launch SARS-CoV2-Elecsys Antigen Test_EN