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Roche’s coronavirus antibody test gets emergency use authorization from the U.S.

A healthcare worker performs laboratory tests.

Sergei Karpukhin | TASS | Getty Images

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.

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