The dispute is expected to affect testing across the U.S. and also raises questions about how regulators and hospitals approve and choose labs.
Federal regulators are investigating a Texas laboratory that a Florida hospital chain dropped last week because of delayed and unreliable COVID-19 test results.
Story continuesThe dispute is expected to affect testing across the U.S. as MicroGen had an undisclosed number of other clients. AdventHealth sent a team to MicroGen's lab after the results were delayed and saw samples left at room temperature, said MicroGen CEO Rick Martin. He maintains the samples were still valid and that the delays were due to AdventHealth not providing proper patient data and the lab running out of plastic parts used in its equipment.
How do labs get approved?The dispute raises questions about how regulators and hospitals approve and choose labs. The FDA was approving EUAs faster earlier in the pandemic, but Wroblewski said the reviews appear to be more exacting now,
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