Roche Coronavirus Antibody Test Wins FDA Approval for Emergency Use
May 03 2020 - 7:53AM
Dow Jones News
By Denise Roland
The Food and Drug Administration has cleared for emergency use
an antibody test from diagnostics giant Roche Holding AG, the
company said Sunday, a move that could add significant capacity to
efforts to determine the wider spread of Covid-19.
Roche's test, which identifies antibodies made by the body to
fight off the new coronavirus, is designed to tell people whether
they have been infected in the past. For many diseases, antibodies
remain in the blood for weeks, months or even years after
infection. Antibody tests are performed on a blood sample and are
different from the swab tests used to diagnose a current
infection.
Antibody tests are seen by many governments around the world as
key to better understanding the spread of mild and asymptomatic
cases of Covid-19, although so far most commercially available
tests -- around 10 have so far received emergency clearance from
the FDA -- aren't deemed accurate enough.
Roche says its test has proven 100% accurate at detecting
Covid-19 antibodies in the blood, and 99.8% accurate at ruling out
the presence of those antibodies. In other words, only two in every
1,000 samples lacking the antibodies would produce a "false
positive" result.
Thomas Schinecker, who leads Roche's diagnostics business, said
in an interview that the company was able to run its test on around
6,000 blood samples, a figure he said was significantly higher than
smaller rivals. He said the test reliably detects antibodies when
the blood sample is drawn at least 14 days after infection.
Governments around the world hope reliable antibody testing
could help gauge how much of the population remains susceptible to
the virus, in order to guide decisions about easing lockdowns. Some
have even considered issuing " immunity passports" to people who
have antibodies that could allow them to, for example, return to
work earlier.
In most infectious diseases, the antibodies produced after a
first infection act quickly to neutralize any subsequent infection,
protecting the person from falling ill again. But even a reliable
antibody test may not be a foolproof way of measuring immunity
against Covid-19. Because the virus is so new, scientists still
don't know how long antibodies remain in the blood. What's more, it
is unclear whether it is possible to fall ill from Covid-19 a
second time, despite the presence of antibodies.
The Swiss health-care giant's heft means it can ramp up the
provision of its antibody test quickly. The test kits are designed
to run on the company's automated machines, which are already
installed in more than 100 laboratories across the U.S. They will
be made available immediately.
Roche says it will be able to churn out test kits, made in
Germany, in the high double-digit millions by June. The company
aims to double that capacity by the end of the year, said Mr.
Schinecker.
Write to Denise Roland at Denise.Roland@wsj.com
(END) Dow Jones Newswires
May 03, 2020 07:38 ET (11:38 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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