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  • Roche gets USFDA...

Roche gets USFDA emergency use nod for coronavirus antibody test

Ruchika SharmaWritten by Ruchika Sharma Published On 2020-05-04T11:22:52+05:30  |  Updated On 4 May 2020 11:22 AM IST
Roche Itovebi recommended by CHMP for EU approval for PIK3CA-mutated, ER-positive, HER2-negative, advanced breast cancer
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Basel: 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% sensitivity3 (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.

Read also: US FDA, EMA Accepted Applications For OCREVUS (Ocrelizumab) Shorter 2-Hour Infusion Time: Roche

rochecovid-19coroanvirususfdaelecsys-anti-sars-cov-2ce-mark
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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