FDA Grants New Coronavirus Test Emergency Approval -- Update
March 13 2020 - 06:45AM
Dow Jones News
By Denise Roland and Peter Loftus
A new, high-speed coronavirus test has been granted emergency
clearance by the Food and Drug Administration, the latest effort to
expand capacity to diagnose the fast-spreading pathogen.
The test was developed by diagnostics giant Roche Holding AG and
is designed to run on the company's automated machines, which are
already installed in more than 100 laboratories across the U.S. It
will be available immediately.
It is only the third coronavirus diagnostic to receive
emergency-use authorization from the FDA, following a test
developed by the Centers for Disease Control and Prevention and one
from the New York State Department of Health.
The FDA has been working to ramp up the speed and quality of
coronavirus testing after a slow and troubled start in the U.S.
Until two weeks ago, only the CDC was authorized to conduct tests,
some of which turned out to be inaccurate. The CDC says it has
since remedied those issues.
Since then, the FDA has given permission to hundreds of U.S.
academic hospital labs to immediately begin using their own tests
for the new coronavirus without first obtaining emergency
authorization. The labs are supposed to follow certain steps to
validate their own tests, and to ultimately seek FDA
authorization.
Currently, all testing is based on identifying unique portions
of the new coronavirus's genetic sequence. But Roche's tests can be
conducted faster than manual laboratory tests. Its machines provide
results in three and a half hours and can run many tests in
parallel -- though as they are located in laboratories, it will
take additional time for samples to be sent for testing. Its most
advanced machine can process around 4,128 samples every 24
hours.
So far, over 13,000 patient specimens have been tested by CDC
and state public-health labs in the U.S., according to figures CDC
posted online.
While capacity has increased, the rollout has been in a
patchwork fashion that still isn't meeting demand for tests.
The spotty rollout of testing in the U.S. has become a
contentious political issue, with members of Congress criticizing
the Trump administration for not having better testing capacity.
The Trump administration has said that sufficient test kits are
available.
An "emergency team" of Roche scientists started work on a new
test as soon as China shared the genetic sequence of the virus in
January. It normally takes years for a new test to be developed and
approved, according to Roche Diagnostics Chief Executive Thomas
Schinecker.
The company has also been working closely with the CDC in the
past few weeks to install more machines across the U.S., said Mr.
Schinecker.
Other diagnostic equipment makers also have been developing new
coronavirus tests, including Qiagen NV, BioMerieux and Abbott
Laboratories. Some hospital systems in the U.S. have developed
their own tests, which will have to seek FDA approval.
Write to Denise Roland at Denise.Roland@wsj.com and Peter Loftus
at peter.loftus@wsj.com
(END) Dow Jones Newswires
March 13, 2020 06:30 ET (10:30 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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