The FDA (Food and Drug Administration) has fast tracked approval for a new coronavirus test kit that will give you the results of your test in just 45 minutes, The new test is from a California Medical company called Cepheid and they plan on starting to ship the tests next week. The company has 23,000 automated systems, 5,00 of them in the United States.
The FDA was able to fast track the approval through the Emergency Use Authorization, a process the helps circumvent the lengthy approval process for drugs, medical supplies and diagnostic measures. One of the biggest problems we have in this country in dealing with the coronavirus is the lack of tests. Once more testing is done, the number of those infected is likely to climb significantly.
Cepheid said that its “point-of-care” test is compatible with 23,000 automated systems it has in hospitals around the world. Five thousand of those are in the United States, the company said in a statement.
“We have developed a test that provides reference lab-quality results in multiple settings where actionable treatment information is needed quickly,” Dr. David Persing, Chief Medical and Technology Officer at Cepheid, said in the statement.
“Our automated systems do not require users to have specialty training to perform testing — they are capable of running 24/7, with many systems already doing so today.” (RELATED: Trump Waives FDA Regulations, Opening Door For Chloroquine To Be Tested As Coronavirus Therapy)
Cepheid did not expect the FDA to approve a speedy test until April at the earliest, the New York Times reported on March 3.
The approval comes as health officials in states hardest hit by the coronavirus pandemic are urging that tests be conducted only on health care workers and people in the hospital. The Washington Post reported that officials in California and New York have said that widespread testing will deplete inventories of medical equipment like gloves and masks, which are already in sparse supply.