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Roche Gets Emergency OK for Coronavirus Antibody Test

FDA approved test as U.S. cases top 1.15 million.

Swiss drug giant Roche  (RHHBY)  got an emergency OK from the Food and Drug Administration for its Covid-19 antibody test over the weekend, as the U.S. clocked in well over 1.15 million total known infections from the novel coronavirus and close to 68,000 deaths. 

The company says the so-called serology test has a "specificity" greater than 99.8% and sensitivity of 100%, within 14 days after confirmation.

As the U.S. looks to reopen after lockdowns and business closures have led to tens of millions of job losses, many are hoping such an antibody test could be a key tool to finding out who could go back to work. Others, however, such as doctors with the World Health Organization, warn it's too early to say that recovering from the virus means immunity. 

"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 health care systems in countries accepting (accepting European approvals) as well as the U.S.," said the company in a statement.

The FDA used its "Emergency Use Authorization" to approve the tests, known as the Elecsys Anti-SARS-CoV-2 antibody test. 

The tests would help determine who has been exposed to the SARS-CoV-2 virus -- the virus that causes Covid-19 -- and have since developed antibodies against it.

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“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 health care systems around the world with an important tool to better manage the Covid-19 health crisis,” said Severin Schwan, CEO of Roche Group, in a statement. "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.”

The tests can also help "assess patients’ immune response to the virus," said the company, noting that "as more is understood about immunity to SARS-CoV-2, the test may help to assess who has built up immunity to the virus."

Late last month, the World Health Organization issued a statement warning that "there is currently no evidence that people who have recovered from Covid-19 and have antibodies are protected from a second infection."

But a virologist with whom TheStreet spoke last week said that it was unlikely people who recovered from the disease would have no immunity from it.

"What I took from that statement is that protective immunity has not yet been conclusively demonstrated, not that there's evidence that there is no protective immunity," said Angela Rasmussen, an associate research scientist at Columbia's Mailman School of Public Health.

"Preliminary data so far does indicate that most patients have measurable antibody responses, and that often these antibodies are neutralizing -- meaning they can bind and inactivate the virus. Furthermore, reinfection did not occur in at least one study using a rhesus monkey model of SARS-CoV-2. All these suggest that most patients will likely develop immunity, but it's still an open question how protective that immunity is and how long that protection lasts," said Rasmussen to TheStreet last week.

Globally, the total known infection count was near 3.5 million with nearly a quarter million deaths on Sunday, according to Johns Hopkins. The U.S. led in both totals.