Diagnostics

Abbott gets emergency use authorization for rapid Covid-19 test

The diagnostics company said it had received the EUA for use of its ID NOW system, which can detect a positive result in as low as five minutes and a negative result in 13 minutes. ID NOW is mainly used in urgent care settings.

The Food and Drug Administration has given an emergency use authorization to a rapid test for the Covid-19 virus made by Abbott Labs.

The diagnostics maker, based in the suburbs of Chicago, said Friday it had received the EUA for a test that is designed to provide results for SARS-CoV-2 infection in as little as five minutes, while being able to provide a negative result in 13 minutes. The test will use Abbott’s ID NOW point-of-care system.

Shares of Abbott were up more than 7% on the New York Stock Exchange Monday morning following the news.

“The Covid-19 pandemic will be fought on multiple fronts, and a portable molecular test that offers results in minutes adds to the broad range of diagnostic solutions needed to combat this virus,” Abbott COO Robert Ford said in a statement. “With rapid testing on ID NOW, healthcare providers can perform molecular point-of-care testing outside the traditional four walls of a hospital in outbreak hotspots.”

The company said it would be making the tests available this week and that it expected to ramp up manufacturing to deliver 50,000 tests per day. Combined with a previous EUA for a Covid-19 test, the company said it expected to produce about 5 million tests per month.

In an email, a spokesperson for the company said it had about 18,000 ID NOW machines across the U.S., though it does not expect all of them to run the Covid-19 test. An ID NOW machine can run about four tests per hour.

Abbott announced on March 18 that the FDA had granted an EUA for its m2000 RealTime test for detecting the coronavirus. The company said it had shipped 150,000 laboratory tests, sending them to hospital and academic medical labs in 18 states, including the hard-hit states of New York, California, Illinois, Washington and Massachusetts.

While the m2000 RealTime platform is used in hospitals and academic medical centers, the majority of ID NOW instruments are in use in urgent care settings.

In a statement Monday, FDA Commissioner Stephen Hahn wrote that the agency “has been providing unprecedented flexibility to labs and manufacturers to develop and offer Covid-19 tests across the U.S. The FDA’s regulations have not hindered or been a roadblock to the rollout of tests during this pandemic.”

Hahn further added that the agency has sought to balance the urgent need for testing and the oversight needed to ensure the tests it authorizes are accurate.

Other tests that have received EUAs include those made by Roche and Thermo Fisher Scientific.

The slow rollout of testing for Covid-19 has been blamed as a major factor for the pandemic virus’ rapid spread in the U.S., compared with South Korea, which performed widespread testing and quarantining early and has begun to get Covid-19 under control, without the need for stringent restrictions on people’s movement. As of Monday, more than 144,000 people in the U.S. were infected with the coronavirus, and more than 2,500 had died.

Photo: Centers for Disease Control and Prevention

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