NEW YORK – Roche announced Monday that its molecular mpox assay Cobas MPXV has been listed under the World Health Organization's Emergency Use Listing (EUL) procedure.
The automated real-time PCR-based test detects DNA from the virus that causes mpox using a dual-target approach and runs on Roche's high-throughput Cobas 6800/8800 systems. The EUL process is intended to accelerate the availability and access to diagnostic tests during a Public Health Emergency of International Concern, Roche said in a statement.
Roche's mpox test received Emergency Use Authorization from the US Food and Drug Administration in 2022.
Earlier this month, Abbott's Alinity M MPXV test was listed under the WHO's EUL procedure. The organization called on mpox IVD manufacturers to submit an expression of interest for EUL on Aug. 28. During the EUL process, medical products are assessed for quality, safety, and performance to guide procurement agencies and WHO member states in making informed decisions for time-limited emergency procurement, the WHO said at the time.