Devices

FDA Probing MicroGen DX Over Covid Test Results

FDA is investigating MicroGenDX, a Texas laboratory that was dropped by a Florida hospital chain due to what it said were delayed and unreliable Covid-19 test results. USA Today reports that AdventHealth, which has 45 hospitals in nine states, terminated its Florida contract with MicroGen DX over questions about the validity of some of the 60,000 tests the lab processed. Advent said it questions results for some of the tests that the lab left out at room temperature for days when they should have been refrigerated.

MicroGen told the newspaper that in addition to the mucus samples processed for Advent it is selling a saliva-only test without an FDA emergency use authorization (EUA), believing that it does not need one. Company CEO Rick Martin said that although he does not believe he needs an EUA, he has applied for one and says FDA is taking too long to approve it.

Advent said it is notifying some 25,000 patients who it believes got unreliable or delayed test results that they should seek medical care and re-testing if they tested negative but have Covid symptoms. It also said that patients who tested positive should be re-tested. It told MicroGen DX to destroy any remaining tests.

Advent said it notified the appropriate regulatory agencies about the issues it experienced and e-mails reviewed by USA Today indicate that FDA investigators are reviewing data and interviewing experts.

Martin said he was unaware of any inquiries about the lab and also said he has started working with the American College of Pathologists on testing requirements.

“We have not been contacted by FDA about any matters related to our testing,” Martin said. “We are confident that should we be contacted by FDA, they will find we meet all requirements. We will fully cooperate with any inquiries.” The agency declined to comment.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome