Federal regulators are investigating a Texas laboratory that a Florida hospital chain dropped last week because of delayed and unreliable COVID-19 test results.
and said he believes FDA is taking too long to approve it. Companies can avoid EUAs unless they get state approval for use only in that state, the FDA said. Spokeswoman Ashley Moore said there were"no authorizations per say at the state level."
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.""We have not been contacted by the FDA about any matters related to our testing," said Martin."We are confident that should we be contacted by the FDA, they will find we meet all requirements.
Health First would not respond to questions about the numbers of tests it sent to MicroGen, but the hospital chain issued a statement last week that said"most labs" it used were meeting their contracted 24-hour turnaround time. The rush to ramp up coronavirus testing during the pandemic created a"wild west opens the opportunity for fraud and abuse," said Dr. Rahul Gupta, a former West Virginia health commissioner, who oversaw that state's lab. The FDA, said Gupta,"should step up in providing more guidance, along with the CDC."
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