Medical Companies Win Approval for Rapid Coronavirus Tests -- Update
March 31 2020 - 11:28AM
Dow Jones News
By Brianna Abbott and Micah Maidenberg
Companies focused on health products and life sciences are
rolling out tests that can quickly detect the new coronavirus
outside of laboratory settings, as officials and labs around the
country race to scale up testing.
Starting this week, Abbott Laboratories plans to make a rapid
test available for use in physicians' offices, urgent-care clinics
and other settings through an Abbott device. The test can detect
the virus in a patient sample in as few as five minutes and return
negative results in 13 minutes.
On Friday, the company said the U.S. Food and Drug
Administration provided emergency authorization to Abbott for the
test. The company received FDA emergency authorization for its own
laboratory test earlier in the month.
Most of the diagnostic tests approved by the FDA so far for
Covid-19, the illness caused by the coronavirus, are conducted in
clinical laboratory settings, sometimes resulting in dayslong
delays if the sample needs to be shipped to another location. A new
wave of point-of-care tests at physicians' offices and urgent-care
clinics could potentially cut down that wait time and increase
capacity, experts say.
Since January, the FDA has granted 20 emergency authorizations
related to the new coronavirus and worked with about 230 test
developers who have or are expected to seek that approval, the
agency said Monday.
Testing for the new coronavirus has gotten off to a slow start,
hampering the country's overall response, and many U.S. labs are
still grappling to acquire supplies and set up testing sites.
Public-health officials need to test for the virus in order to
track and isolate patients and combat its spread, and health-care
workers need to know who is infected in order to take the proper
precautions and provide the right care.
While testing has greatly expanded in the past several weeks and
continues to ramp up across the country, the ability for Americans
to get tested is still highly uneven.
There are more than 160,000 confirmed cases of the coronavirus
in the U.S., according to the latest data available from Johns
Hopkins University. Trump administration officials have said
patients who are hospitalized or in an intensive-care unit are the
main priorities for testing.
Criteria for who can actually get tested in the U.S. have
largely been limited to severely ill patients and those in
high-risk groups, as hospitals, medical centers and governments
often have to ration who receives a test due to the limited
supplies.
"With new tools like point-of-care diagnostics, we are moving
into a new phase of testing, where tests will be much more easily
accessible to Americans who need them," said Health and Human
Services Secretary Alex Azar earlier this month.
Privately held Mesa Biotech Inc. said last Tuesday that it
received emergency FDA approval for a coronavirus test that
generates diagnostic results through one of its devices in 30
minutes.
Henry Schein Inc., a distributor, said Thursday it would start
offering a blood test to detect coronavirus antibodies, a sign of
past or current infection, that delivers results within 15 minutes
from a pinprick. The company said it expects to have "at least
several hundred-thousand tests available by March 30 and
significantly increased availability beginning in April 2020."
Cepheid, part of Danaher Corp., received the first emergency
authorization for a Covid-19 test that medical professionals could
use in point-of-care settings, the FDA said March 21. That test
returns results in about 45 minutes on a Cepheid device, according
to the company.
"The impact of rapid testing will be significant," said David
Alland, director of the Public Research Health Institute at Rutgers
New Jersey Medical School, whose team helped evaluate the Cepheid
test. "It will be a game-changer for crucial medical decisions,
including how to triage patients, when to isolate and how to
treat."
Write to Brianna Abbott at brianna.abbott@wsj.com and Micah
Maidenberg at micah.maidenberg@wsj.com
(END) Dow Jones Newswires
March 31, 2020 11:13 ET (15:13 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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