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Roche Wins FDA Authorization On High-Volume Monkeypox Test

 
• By Elizabeth Orr

The test, which is the first for the condition to win an EUA using actual patient samples, provides results in about three and a half hours. 

Monkeypox Test Tube
• Source: Shutterstock

A high-volume automated monkeypox diagnostic from Roche Diagnostics Corp. has been granted an Emergency Use Authorization by the US Food and Drugs Administration, the company announced recently. The cobas MPXV is the first test for the disease to be authorized based on clinical trials that used actual patient samples.

The cobas MPXV, which can be used with Roche’s cobas 6800/8000 systems, is a real-time polymerase chain reaction (PCR) test...

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