Roche launches laboratory test to detect antigen of SARS-CoV-2 to support high-volume testing of suspected COVID-19 patients
- The SARS-CoV-2 Antigen test is an automated laboratory assay intended as an aid in the diagnosis of active SARS-CoV-2 infection
- Roche will be able to ramp up to a double-digit million number of tests per month, by early 2021
- The test is the latest addition to Roche’s comprehensive COVID-19 portfolio and can help in the management of patients for optimal care delivery
Basel, 11 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has launched a high-throughput SARS-CoV-2 antigen test as an aid in the diagnosis of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infections, in markets accepting the CE Mark. Roche has also filed for Emergency Use Authorisation (EUA) from the U.S. Food and Drug Administration.
It is planned to ramp up production to have a double-digit million number of tests per month, in early 2021, depending on the demand of healthcare systems, globally. The test is performed by healthcare professionals and uses nasopharyngeal or oropharyngeal swab samples from patients with symptoms suggestive of COVID-19, or people with either known or suspected exposure to SARS-CoV-2. A widely available, laboratory-based automated antigen assay allows for cost and error reduction due to removal of manual handling as well as fast turn-around times and high test throughput.
“Healthcare systems remain under significant pressure to deliver robust testing options, with a sufficient number of tests available”, said Thomas Schinecker, CEO Roche Diagnostics. “The launch of our high-throughput antigen test will provide additional testing capacity to reliably support healthcare systems in diagnosing SARS-CoV-2 infection, as a supplement to PCR testing.”
About the SARS-CoV-2 Antigen test
Roche’s SARS-CoV-2 Antigen test is an immunoassay intended for the qualitative detection of SARS-CoV-2 present in the respiratory tract including nasopharynx and oropharynx. The SARS-CoV-2 Antigen test is performed by healthcare professionals and could be used as an alternative or in conjunction with PCR testing. This is highly beneficial where reliable laboratory PCR testing is limited or not available.
About antigen testing
An antigen test detects proteins which are structural or functional components of a pathogen and are thus very specific to that pathogen.2 In this case, the test would provide a qualitative “yes/no” answer on the presence of the pathogen in the patient sample. If the target antigen is present in sufficient concentrations in the sample, it will bind to specific antibodies and generate a positive result, indicating an active infection.3
About Roche’s response to the COVID-19 pandemic
As a leading healthcare company we are doing all we can to support countries in minimising the impact of COVID-19. We have developed a growing number of diagnostic solutions that help to detect and diagnose the infection in patients, as well as providing digital support to healthcare systems, and we continue to identify, develop and support potential therapies which can play a role in treating the disease.
We understand the impact of COVID-19 goes beyond those who contract it, which is why we are working with healthcare providers, laboratories, authorities and organisations to help make sure that patients continue to receive the tests, treatment and care they need during these challenging times. As we learn from the pandemic, we are partnering with governments and others to make healthcare stronger and more sustainable in the future.
Our diagnostics solutions:
Reliable, high-quality testing is essential to help healthcare systems overcome this pandemic. Our portfolio includes:
- a 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 antibody test, aimed at detecting the presence of antibodies in the blood targeting the nucleocapsid (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)
 Full specifications of the Roche immunoassay systems, including throughput, can be found on our diagnostics.roche website
 European Centre for Disease Prevention and Control. Diagnostic testing and screening for SARS-CoV-2. 2020. https://www.ecdc.europa.eu/en/covid-19/latest-evidence/diagnostic-testing Accessed July 2020
 Nucleocapsid protein (qualitative)
 Spike protein (quantitative)