LabCorp Gets First FDA Greenlight for SARS-CoV-2 Differentiation Test
For the first time, the FDA has granted emergency use authorization for a test to differentiate strains of the SARS-CoV-2 virus.
New VALID Act Would Establish Risk-Based System for LDTs Regulation
Senate committee members propose a modified version of legislation allowing the FDA to continue to regulate LDTs on a risk-tiered basis.
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What Happens to COVID Tests After Public Health Emergency Ends?
The FDA will almost certainly keep EUA tests on the market after the PHE expires.
FDA Issues First Approval for SARS-CoV-2 Breathalyzer Test
InspectIR COVID-19 device detects the virus from breath samples in less than three minutes, offering a new screening option.
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EUA COVID-19 Tests to Remain on US Market After PHE Expires
The FDA has plans to ensure COVID-19 test makers won’t be left high and dry when the public health emergency ends.
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