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Abbott Laboratories : Medical Companies Win Approval for Rapid Coronavirus Tests -- Update

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03/31/2020 | 11:14am EDT

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


Stocks mentioned in the article
ChangeLast1st jan.
ABBOTT LABORATORIES -0.69% 91.43 Delayed Quote.6.03%
DANAHER CORPORATION 0.03% 163.93 Delayed Quote.4.76%
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