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Over 100 Companies Market Unapproved COVID-19 Tests In US

The medical industry has been taking advantage of the lighter regulations set by the federal government to produce testing kits for COVID-19 amid the pandemic. But experts warned that many companies have been improperly marketing products that may not work as they should.  

There are now millions of coronavirus tests being offered to the U.S. healthcare system. Companies claim the tools would help speed up detection of the infection, which could play an important role in containing the virus and reopening the country.
 
Companies started to accelerate production of the testing kits after the Food and Drug Administration (FDA) authorized companies and labs to sell kits without approval during the COVID-19 pandemic. The agency only requires the products to be validated internally and packaged with appropriate disclaimers, Business Insider reported.

More than 100 companies responded to FDA’s decision and started manufacturing testing kits in March. However, experts found problems in many tests, with some tools providing less than 90 percent accuracy or without information on its accuracy. 

Severin Schwan, CEO of pharmaceutical company Roche, previously criticized some rival companies for offering faulty tests. He said it can be easy to develop an antibody test but “it’s not so easy” to build a precise, reliable tool.

“It’s a disaster,” Schwan said as quoted by Business Insider. “These tests are not worth anything, or have very little use.”

Roche has been working on its own coronavirus serology kit. The company said the production process relies on extensive studies and may be complete by May. 

Most of the testing kits being offered to the U.S. market come from China, according to the New York Times. Only three companies and the Mount Sinai Health System have emergency authorization to manufacture antibody tests but 117 companies are already selling the tools.

Some of the tests may provide inaccurate findings. Matthew Harrison, a managing director in biotechnology research for Morgan Stanley, explained that they might detect antibodies in the blood that fight other types of coronaviruses instead of the virus that causes COVID-19. 

“It’s useful towards trying to understand the scope of the prior outbreak and the scope of how new outbreaks may unfold,” he said. “But it’s not as important from a surveillance capability as running RNA tests and being able to contact trace those people.”

Coronavirus COVID-19 Laboratory Test, Cure, Vaccine Andressa Parreiras, Biomedic, and Larissa Vuitika, biologist, work in a laboratory during the extraction of the virus genetic material on March 24, 2020 in Belo Horizonte, Brazil. The Ministry of Health convened The Technological Vaccine Center of the Federal University of Minas Gerais laboratory to conduct research on the coronavirus (COVID-19) in order to diagnose, test and develop a vaccine. According to the Ministry of Health, as of Tuesday, March 24, Brazil has 1.891 confirmed cases of the coronavirus (COVID-19) and at least 34 recorded deceases. Pedro Vilela/Getty Images





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