Roche's COVID-19 antibody test nets FDA emergency authorization

Roche
When used at least two weeks after an active COVID-19 infection has been confirmed by a molecular diagnostic and after the body’s immune system has had time to develop antibodies, Roche's test can be nearly 100% accurate, according to the company. (Roche)

The FDA granted an emergency green light to Roche and its previously announced antibody blood test for gauging people’s exposure and immune response to the novel coronavirus. 

The Big Pharma said it has already begun shipping the Elecsys diagnostic kits to laboratories and plans to ramp up production to the “high double-digit millions per month” in May for the U.S. market and abroad. To help do it, the company plans to invest $459 million into its manufacturing facility in Penzberg, Germany, according to reports.

Also available under a CE mark, the test is designed to run on Roche’s cobas e hardware, providing a single result in about 18 minutes and running up to 300 tests per hour.

“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,” Roche CEO Severin Schwan, Ph.D., said in a statement.

RELATED: COVID-19 antibody testing 'a disaster,' says Roche CEO, as diagnostics sales rise

”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,” Schwan added.

According to the company, when used at least two weeks after an active COVID-19 infection has been confirmed by a molecular diagnostic—and after the body’s immune system has had time to respond by developing potentially protective antibodies, which can take days—the test can be highly accurate, with 100% sensitivity and a specificity higher than 99.8%.

RELATED: With the world waiting, Roche socks $459M into COVID-19 antibody test production

In addition, the test showed no false-positive results when checked against four other human coronaviruses, such as strains that cause the common cold. However, it is still unknown exactly how the presence of certain antibodies could translate to protective immunity against the novel coronavirus that causes COVID-19, or for how long.

Editor's note: This story has been updated regarding Roche's investment into its German manufacturing plant.

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