CORONAVIRUS

Local Company Manufacturing 50K Coronavirus Tests Daily, Could Soon Be Used In Utah

Mar 17, 2020, 11:18 PM

SALT LAKE CITY, Utah — A local company’s coronavirus test could soon give the state a boost in testing for the virus after the U.S. Food and Drug Administration changed its policy, giving states responsibility for testing and allowing more laboratories to participate.

“We’re seeing unprecedented things happen,” said Seth Egan, international sales director at Co-Diagnostics. “It has been nonstop here.”

In the race to slow the spread of COVID-19, state epidemiologist Dr. Angela Dunn said Tuesday, “testing and identifying those who have COVID-19 is an essential piece in slowing the pandemic.”

For that reason, Co-Diagnostics in Salt Lake City jumped into the fight early to develop a test that could offer results in less than two hours. Egan says they can manufacture 50,000 of those tests at day at their Utah lab.

So far, those tests have only been available out of the country and to certain labs in the U.S., but that’s no longer the case after the FDA changed its policy.

“We hope that with that policy change last night that can open the doors to getting more products in our communities,” Egan said. “We certainly can service the need that Utah has seen, in our opinion.”

According to the FDA press release, the updated policy means “States can set up a system in which they take responsibility for authorizing such tests and the laboratories will not engage with the FDA…Laboratories developing tests in these states can engage directly with the appropriate state authorities, instead of with the FDA.”

The FDA’s original policy also only made tests available to “laboratories that are certified to perform high-complexity testing consistent with requirements under the Clinical Laboratory Improvement Amendments,” according to the press release. “Under the update…the agency does not intend to object to commercial manufacturers distributing and labs using new commercially developed tests.”

“We hope and would like the availability of testing statewide for whoever is showing symptoms, but that’s just not the case right now,” Dunn said during a daily COVID-19 public briefing on Tuesday. “Unfortunately, we are faced with infrastructure and logistical challenges that prevent us from being able to test everybody. There’s not a win in that situation it’s just what we have to do.”

Egan said he hopes Co-Diagnostics can now help fill the need.

“Individuals who now need a test should have an easier way of getting through the gates,” Egan said. “Instead of having to fit into a specific category of having traveled to country x, y or z, if you’re showing symptoms, we believe you should be able to get a test.”

The test would not be available at home or doctors’ offices. Egan said the company is talking with health officials at the Utah Department of Health to make the test available at labs across the state.


Coronavirus Resources

How Do I Prevent It?

The CDC has some simple recommendations, most of which are the same for preventing other respiratory illnesses or the flu:

  • Avoid close contact with people who may be sick
  • Avoid touching your face
  • Stay home when you are sick
  • Cover your cough or sneeze with a tissue and then throw the tissue in the trash
  • Wash your hands often with soap and water for at least 20 seconds, especially after going to the bathroom, before eating, and after blowing your nose, coughing or sneezing. Always wash your hands with soap and water if your hands are visibly dirty.
  • If soap and water are not readily available, use an alcohol-based hand sanitizer with at least 60% alcohol.

The CDC does not recommend wearing a face mask respirator to protect yourself from coronavirus unless a healthcare professional recommends it.

How To Get Help

If you’re worried you may have COVID-19, you can contact the Utah Coronavirus Information Line at 1-800-456-7707 to speak to trained healthcare professionals. You can also use telehealth services through your healthcare providers.

Additional Resources

If you see evidence of PRICE GOUGING, the Utah Attorney General’s Office wants you to report it. Common items in question include toilet paper, water, hand sanitizer, certain household cleaners, and even cold medicine and baby formula. Authorities are asking anyone who sees price gouging to report it to the Utah Division of Consumer Protection at 801-530-6601 or 800-721-7233. The division can also be reached by email at consumerprotection@utah.gov.

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Local Company Manufacturing 50K Coronavirus Tests Daily, Could Soon Be Used In Utah