New COVID-19 Test Authorized By US FDA – WASHINGTON, D.C. — The US Food and Drug Administration has authorized the first rapid diagnostic test that could detect the novel coronavirus in approximately 45 minutes, according to CNN.
The authorization was made Friday by California-based Cepheid, which makes the test, and tests will begin shipping next week.
“During this time of increased demand for hospital services, Clinicians urgently need an on-demand diagnostic test for real-time management of patients being evaluated for admission to health-care facilities,” said Dr. David Persing, MD, Ph.D., chief medical and technology officer at Cepheid.
“An accurate test delivered close to the patient can be transformative and help alleviate the pressure that the emergence of the COVID-19 outbreak has put on healthcare facilities that need to properly allocate their respiratory isolation resources,” Persing added.
The test is a significant advancement because some patients have complained it took them days to get results.
Vice President Mike Pence announced Saturday during a news briefing on coronavirus response that more than 195,000 Americans have been tested for the virus as cases surpassed 22,000, with about half confirmed in New York.
Pence further explained the number does not include county hospitals or health care labs around the country. Currently, only 19,343 tests have come back positive, Pence said.
Officials continue to urge Americans to only take the test if they are symptomatic and not for those who do not show signs that they could be infected with the disease.
“We want to remind Americans if you don’t have symptoms, don’t do a test,” the vice president said Saturday.” It is another way that the American people can make sure that we are preserving the resources that our health care workers need to administer and support those who are dealing with the coronavirus and other illnesses.”
Pence and his wife Karen tested negative for the coronavirus according to a spokeswoman from the VP’s office.