Roche COVID-19 antibody test wins FDA approval for emergency use

Roche has announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for its new Elecsys^® Anti-SARS-CoV-2 antibody test. The test is designed to help determine if a patient has been exposed to the SARS-CoV-2 virus and if the patient has developed antibodies against SARS-CoV-2. Roche has already started shipping the new antibody test to leading laboratories globally and will ramp up production capacity to high double-digit millions per month to serve healthcare systems in countries accepting the CE mark as well as the U.S.

“Thanks to the enormous efforts of our dedicated colleagues we are now able to deliver a high-quality antibody test in high quantities, so we can support healthcare systems around the world with an important tool to better manage the COVID-19 health crisis,” said Severin Schwan, CEO Roche Group. ”I am in particular pleased about the high specificity and sensitivity of our test, which is crucial to support health care systems around the world with a reliable tool to better manage the COVID-19 health crisis.”

“Our best scientists have worked 24/7 over the last few weeks and months to develop a highly reliable antibody test to help fight this pandemic,” said Thomas Schinecker, CEO Roche Diagnostics. “Roche is committed to helping laboratories deliver fast, accurate, and reliable results to healthcare professionals and their patients.”

Roche’s SARS-CoV2 antibody test, which has a specificity greater than 99.8% and 100% sensitivity (14 Days post-PCR confirmation), can help assess patients’ immune response to the virus. As more is understood about immunity to SARS-CoV-2, the test may help to assess who has built up immunity to the virus.

With extensive global manufacturing capabilities, Roche will be able to deliver high double-digit millions of tests per month. Hospitals and reference laboratories can run the test on Roche’s cobas e analysers, which are widely available around the world.

For countries with specific regulatory requirements, local approval timelines apply. In addition there may be other country-specific regulations, such as import requirements, which will determine when the test becomes available locally. Roche will work closely with the respective regional representatives to ensure we appropriately support local registration efforts.

About antibody testing

An antibody test, also called a serology test, is used to determine whether a person might have gained immunity against a pathogen or not. The human body makes antibodies in response to many illnesses. In the current situation of the COVID-19 pandemic, antibody tests need to be able to specifically detect antibodies against SARS-CoV-2 with no cross-reactivity to other similar coronaviruses, which could generate a false positive result and thus wrongly indicate potential immunity. A false positive result happens when a person receives a positive test result, when they should have received a negative result. False positives are particularly critical when we do not know how many people in a given population have had COVID-19. As of 24 April 2020, no study has evaluated whether the presence of antibodies to SARS-CoV-2 confers immunity to subsequent infection by this virus in humans.

About Elecsys Anti-SARS-CoV-2 serology test

Elecsys^® Anti-SARS-CoV-2 is an immunoassay for the in-vitro qualitative detection of antibodies (including IgG) to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in human serum and plasma. Through a blood sample, the test, which is based on an in-solution double-antigen sandwich format, can detect antibodies to the new coronavirus causing COVID-19, which could signal whether a person has already been infected and potentially developed immunity to the virus. Based on the measurement of a total of 5272 samples, the Elecsys^® Anti-SARS-CoV-2 assay has 99.81% specificity and shows no cross-reactivity to the four human coronaviruses causing common cold. This means it can lower the chance of false positives due to the detection of similar antibodies that may be present in an individual, but are specific for coronaviruses other than SARS-CoV-2. Elecsys^® Anti-SARS-CoV-2 detected antibodies with 100% sensitivity in samples taken 14 days after a PCR-confirmed infection. The importance of specificity and sensitivity of a particular test will be dependent on its purpose and disease prevalence within a given population.

Hospitals and reference laboratories can run the test on Roche’s cobas e analysers, which are widely available around the world. These fully automated systems can provide SARS-CoV-2 test results in approximately 18 minutes for one single test, with a test throughput of up to 300 tests/hour, depending on the analyser.

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