FDA Issues EUA For DiaCarta’s Monkeypox Test Kit

 
• By Brian Bossetta

The US Food and Drug Administration has granted an emergency use authorization to DiaCarta for its PCR monkeypox diagnostic kit.

MPOX
• Source: Shutterstock

Precision molecular diagnostics company DiaCarta has received an emergency use authorization (EUA) from the US Food and Drug Administration for its QuantiVirus MPXV test, a real-time multiplex PCR test intended for the qualitative detection of monkeypox virus DNA in human lesion swab specimens.

The test from the Pleasanton, CA-based company is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988...

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