Home News FDA investigates lab as tens of thousands of COVID-19 test results in Florida are questioned

FDA investigates lab as tens of thousands of COVID-19 test results in Florida are questioned

by Paul Goldberg

“AdventHealth said it is notifying about 25,000 patients who got unreliable or delayed results. It is advising them to seek medical care & retesting if they tested negative but have COVID symptoms. Patients who tested positive should also seek retesting.”

USAToday reports AdventHealth, which has 45 hospitals in nine states, terminated its Florida contract with MicroGen DX due to concerns about the validity of some of the 60,000 tests MicroGen had processed for the system because the lab left them at room temperature for days, according to an AdventHealth statement.

The specimens should be refrigerated at 2 to 7 degrees Celsius (about 32 degrees Fahrenheit) and then put in freezers at -70 degrees Celsius after three days, according to the Centers for Disease Control and Prevention.

MicroGen promotes shipping COVID-19 sputum (mucus) samples through FedEx on its website.

The company is also selling a saliva-only test that can be administered in a “hospital, clinic, drive-thru clinic or at-home,” in all 50 states without an Emergency Use Authorization from the Food and Drug Administration, said MicroGen spokeswoman Ashley Moore.

An authorized Emergency Use Authorization is required in a public health emergency, according to the Food and Drug Administration, for “any COVID-19 test for at-home testing, with or without the use of telemedicine.”

MicroGen CEO Rick Martin said he doesn’t believe the company needs one. He filed for one anyway and said he believes FDA is taking too long to approve it.

Companies can avoid EUAs if they get state approval for use only in that state, the FDA said.

Spokeswoman Ashley Moore said there were “no authorizations per se at the state level.”

AdventHealth said it is notifying about 25,000 patients who got unreliable or delayed results.

It is advising them to seek medical care and retesting if they tested negative but have COVID symptoms.

Patients who tested positive should also seek retesting, AdventHealth said.

It told the lab to destroy remaining tests and said its patients who haven’t received results from MicroGen DX will never receive them.

The dispute is expected to affect testing across the U.S. as MicroGen had an undisclosed number of other clients.

AdventHealth said Monday it “notified the appropriate regulatory agencies of the issues we experienced with this lab.”

FDA investigators are reviewing data and interviewing experts, according to emails reviewed by USA TODAY.

In a statement, Martin said he was unaware of “any inquiries into our lab,” but added that after the AdventHealth announcement it started working with the American College of Pathologists on its testing requirements, “which we are confident we will continue to meet.”

The FDA declined to comment.

Read more here. 

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