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DiaSorin Simplexa COVID & Flu A/B Assay Gets FDA Clearance

Posted by Andy Lundin | Mar 21, 2023 | Covid 19 |

DiaSorin received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Simplexa COVID & Flu A/B Direct assay.

Pharyngitis testing and diagnosis can be improved by utilizing existing molecular testing capacity increased due to COVID.

Cue Health has received EUA from the U.S. Food and Drug Administration (FDA) for its molecular test to detect the mpox (monkeypox) virus.

INTEGRA Biosciences acquired Miroculus, a biotechnology specialist focused on developing hands-off automation solutions for NGS protocols.

Though not a new diagnostic technique, multiplex testing is poised to become the standard of diagnostic care in the post-pandemic world.