EUA - G2 Intelligence

The Diagnostics Pipeline: First FDA Approval of CRISPR Therapy Possible This Year

The agency recently announced it will decide in December whether to grant clearance for a CRISPR therapy for treating sickle cell disease.

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So far, it appears many post-PHE COVID-19 tests will be panels for detecting and differentiating among multiple respiratory viruses.

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Lucira has fallen on hard times since it secured the first FDA EUA for an at-home COVID-19 test in November 2020.

COVID-19 test makers will either have to get full marketing approval, or take the product off the market.

On March 27, the agency released a new guidance document to help test developers make the transition to full approval.

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