Stanford test for COVID-19 receives FDA approval

Encouraging news in the fight to stem the spread of the COVID-19 (coronavirus). Stanford researchers say they’ve developed a test that could be ready to use by the end of the week. That test has already received FDA approval.

“Basically it’s a test that um as I said detects the viral nucleic acid, the RNA and that identifies the organism,” said Dr. Stan Deresinkski, a clinical professor of infectious diseases at Stanford University.

He said test subjects are swabbed in the nose and mouth for a sample. That sample is then tested, and roughly six hours later, will determine if the patient is positive or negative for Coronavirus. Deresinski said the test is highly sensitive and accurate.

“The laboratory here is going to be required to send their first  five positive samples and five negative samples to the CDC for them to retest to confirm the accuracy of the test,” he said.

The tests here at Stanford could begin by the end of the week, and would involve people who are symptomatic, and who’ve either been in contact with someone who has coronavirus, or who have traveled to a highly infectious area. The next hurdle for doctors – developing a cure. Experts say that isn’t likely before the late summer or fall, at the earliest.

“It’s imperative to show safety. You don’t want a drug that cures a virus but causes for example liver disease,” said Dr. Mark Schwartz, a San Jose State University biochemist and consultant.

He said some drugs currently being tested to combat coronavirus have already passed some safety hurdles. But if they aren’t effective and researchers must start from scratch, a cure won’t come until next year.

“It takes time to enroll persons in a trial. To show you can make the drug safely and under the appropriate level of purity. And it takes time to test the drug and monitor for long-term side effects as well,” said Dr. Schwartz.

At Stanford, experts say the possible advent of testing later this week will like produce a spike in the number of Coronavirus cases.

“There will be a big jump in numbers, at least initially, simply because many, many, more people are being tested,” said Dr. Deresinski.

He said the public shouldn’t panic, but instead, anticipate more cases, as health experts continue on a path to slow the spread of this virus.