Medical Device Company Set to Manufacture 1 Million Coronavirus Tests a Week After Receiving FDA Approval

A medical device company says it will ramp up production to manufacture a million coronavirus tests a week, after receiving approval from the U.S. Food and Drug Administration (FDA).

Abbott Laboratories is the the latest company to receive an Emergency Use Authorization (EUA) to help make up for a lack of testing that has severely hindered the country's ability to track the spread of COVID-19, the illness caused by the virus.

The company said it plans to immediately distribute around 150,000 tests across the U.S. and will continue to ramp up production to provide up to 1 million tests per week by the end of the month.

The tests will be done on Abbott's m2000 platform, which is currently installed in 175 hospitals and labs across the country. The systems can run up to 470 tests in 24 hours, the company said.

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A spokesperson confirmed to Newsweek that tests are being sent to hospitals and medical centers in 18 states, including three of the hardest hit by the pandemic—Washington, California and New York.

Coronavirus testing
Healthcare workers handle samples from patients at the drive-in center at ProHealth Care on March 18, 2020 in Jericho, New York. Bruce Bennett/Getty Images

"A global challenge like coronavirus requires the commitment and cooperation of everyone who has the ability to help address it," Abbott's chairman and CEO Miles White said. "I'm proud of the Abbott team and what they've accomplished in such a sort period of time, and I want to thank the Administration and the FDA for their partnership in making this happen."

Last week, the FDA issued emergency authorizations for COVID-19 tests made by two other companies—Massachusetts-based Thermo Fisher Scientific and Swiss pharmaceutical firm Roche.

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Thermo Fisher Scientific said Monday that the company currently has 1.5 million tests available under the EUA label and that it expects to quickly ramp up production to reach 2 million tests per week. A spokesperson for the company also confirmed to Newsweek that production is expected to scale up to five million tests a week at some point in April.

This week, EUAs for COVID-19 tests were also issued to Hologic and LabCorp.

FDA Commissioner Stephen Hahn said that the agency has been in touch with 90 test developers that want to make their kits available through the EUA process since the beginning of the new coronavirus outbreak.

"Staff at FDA have been working nonstop to expedite the review and authorization of diagnostics during this public health emergency," he said in a statement this week.

"Our device center has been in continual contact with the medical device community, in particular diagnostic developers, since January—providing technical assistance to test developers to help facilitate the availability and distribution of tests so that health care professionals can accurately detect the COVID-19 virus."

He added: "We stand ready to continue to support medical products in the pipeline to fight this virus."

According to the COVID Tracking Project, just over 82,000 tests for COVID-19 have been carried out in the U.S. as of Thursday morning.

The increase in testing has led to a surge in confirmed cases. More than 9,400 cases have been confirmed in the U.S. as of Thursday morning and 150 people have died, according to Johns Hopkins University. More than 100 people have recovered.

Globally, the new coronavirus has sicked almost 220,000 people and killed more than 8,900. More than 84,000 people have recovered.

World Health Organization advice for avoiding spread of coronavirus disease (COVID-19)

Hygiene advice

  • Clean hands frequently with soap and water, or alcohol-based hand rub.
  • Wash hands after coughing or sneezing; when caring for the sick; before, during and after food preparation; before eating; after using the toilet; when hands are visibly dirty; and after handling animals or waste.
  • Maintain at least 1 meter (3 feet) distance from anyone who is coughing or sneezing.
  • Avoid touching your hands, nose and mouth. Do not spit in public.
  • Cover your mouth and nose with a tissue or bent elbow when coughing or sneezing. Discard the tissue immediately and clean your hands.

Medical advice

  • If you feel unwell (fever, cough, difficulty breathing) seek medical care early and call local health authorities in advance.
  • Stay up to date on COVID-19 developments issued by health authorities and follow their guidance.

Mask usage

  • Healthy individuals only need to wear a mask if taking care of a sick person.
  • Wear a mask if you are coughing or sneezing.
  • Masks are effective when used in combination with frequent hand cleaning.
  • Do not touch the mask while wearing it. Clean hands if you touch the mask.
  • Learn how to properly put on, remove and dispose of masks. Clean hands after disposing of mask.
  • Do not reuse single-use masks.
Medical Device Company Set to Manufacture 1 Million Coronavirus Tests a Week After Receiving FDA Approval | U.S.