Further, on March 17, new FDA guidance allowed a number of other companies to sell coronavirus tests to a wide array of U.S. laboratories without an EUA. Under the new guide, laboratories that meet certain criteria can begin testing prior to asking for FDA authorization.
Surge In Orders For Coronavirus Tests
One of them is Salt Lake City-based Co-Diagnostics (CODX), which already has won approval to market its tests in Europe.
"We've seen a tremendous surge in orders," Chief Executive Dwight Egan told Investor's Business Daily. "We are shipping to five continents."
The new diagnostics aim for significantly faster return times than the initial coronavirus test developed by the CDC. When the CDC test first arrived on the scene Feb. 4, the results had to go to Atlanta. It could take up to 48 hours to process the test and confirm the results, Verdict Medical Devices writer Chloe Kent said in a recent report.
Roche pledges to have results identifying a Covid-19 infection in 3-1/2 hours. Becton Dickinson (BDX), one of the companies affected by the relaxed March 17 guidance, says its test is complete in two to three hours. Co-Diagnostics aims to do better: 90 minutes.
All of the companies have been quiet so far about the number of tests they're selling or how quickly they can ramp up production.
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