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Roche’s COVID-19 antibody test approved for emergency use in the US

Ramps up capacity for testing across the country

Roche

Swiss pharma company Roche has scored an emergency use authorisation from the US Food and Drug Administration (FDA) for its new COVID-19 antibody test.

The Elecsys anti-SARS-CoV-2 antibody test is designed to determine if a patient has been exposed to the novel coronavirus, also known as SARS-CoV-2, and if they have developed antibodies against it.

According to Roche, the new antibody test has already started shipping to leading laboratories across the world, and the company plans to further ramp-up production capacity to provide high double-digit millions of the test per month. Hospital and reference labs can run the test using Roche’s comas e analysers, which the company says are widely available globally.

The antibody tests will be available in countries accepting the CE mark as well as in the US. A CE mark indicates conformity with health safety and environmental protection standards for products sold within the European Economic Area, meaning the test can be legally commercialised in the EU. For countries with specific regulatory requirements, local approval timelines will apply to the new antibody test.

The antibody test has a specificity greater than 99.8% and 100% sensitivity, meaning it can help to assess patients’ immune response to the virus. Roche added that as researchers learn more about SARS-CoV-2, the test may also be able to help assess who has built up an immunity to the virus.

“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 of Roche Diagnostics.

“Roche is committed to helping laboratories deliver fast, accurate and reliable results to healthcare professionals and their patients,” he added.

In March, Roche won emergency use for its coronavirus diagnostic test, which was indicated for the qualitative detection of SARS-CoV-2. Millions of these tests were made available for use on Roche’s cobas 6800/8800 systems in labs across the world.

Antibody testing in particular has been identified as a valuable tool in the continued fight against the coronavirus. According to health experts, antibody tests will help authorities to gain a clearer picture of how far the infection has spread across the population.

In the UK, Imperial College London is set to lead a major home testing programme, which aims to evaluate the accuracy and ease of use of a range of antibody tests.

Article by
PMGroup

4th May 2020

From: Research

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