Roche's Coronavirus Antibody Test Gets Emergency Use Authorization From the U.S.

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  • Roche has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for a new test that measures levels of Covid-19 antibodies.
  • The Swiss diagnostics and pharmaceutical giant said on Wednesday that the test, called the "Elecsys Anti-SARS-CoV-2 S" test, specifically detects antibodies against the coronavirus spike protein within a blood sample.

Roche received emergency use authorization (EUA) from the U.S. Food and Drug Administration for a new test that measures coronavirus antibodies within the blood.

The Swiss diagnostics and pharmaceutical giant said Wednesday that the test, called "Elecsys Anti-SARS-CoV-2 S," specifically detects antibodies against the virus' spike protein within blood samples.

Roche said it's antibody test works by targeting "antibodies that are directed against the region of the novel coronavirus known as the spike protein, specifically the area that enables the virus to bind to a host cell receptor, which is required for the virus to enter the host cell."

It appeared to be positioning its tests as a way to gauge individuals' antibody response to coronavirus vaccines that could soon become widely available, noting that "many current candidate vaccines aim to induce an antibody response against the coronavirus spike protein. Tests that quantify antibodies to the spike protein could be used to measure the level of that response and track that measurement over time."

The test provides a numerical result describing the concentration of antibodies as well as a qualitative result, Roche said, as its CEO hailed the test as a way to measure future "vaccine-induced immune responses."

"Since the start of this pandemic, our focus has been to bring effective diagnostic testing solutions to the fight against Covid-19," Roche Diagnostics' CEO Thomas Schinecker said in a press release.

"Antibody tests like these will play a critical role in measuring a person's vaccine-induced immune response," he added.

Vaccine optimism

Roche's announcement comes amid optimism that there could soon be a mass rollout of coronavirus vaccines. 

Pfizer and BioNTech, Moderna and AstraZeneca have all developed vaccine candidates that are seen to be highly effective in clinical trials and all are now awaiting emergency approval from health regulators. On Wednesday, the U.K. became the first country in the world to approve Pfizer and BioNTech's vaccine for use.

The EUA granted by the FDA for Roche's antibody test follows similar approval in mid-September in Europe, or specifically, in markets that accept the "CE mark." The CE mark shows products sold conform with European health, safety, and environmental protection standards.

Roche said that clinical laboratories can run its antibody tests on its own analytical units, and can receive results in around 18 minutes, with a test throughput of up to 300 tests per hour, depending on the analyzer.

In addition, Roche said that "the test may help guide the allocation of plasma donations from recovered Covid-19 patients to current patients by identifying donors that have antibodies to SARS-CoV-2 virus."

Convalescent plasma therapy is an investigational procedure that separates and removes the plasma from a patient's blood. This plasma is then replaced with plasma from a donor to give the ill patient antibodies to help fight the virus. 

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