As part of ongoing efforts to enhance quality-assured testing options, the World Health Organization (WHO) has listed two additional mpox in vitro diagnostics under its Emergency Use Listing (EUL) procedure. WHO’s EUL is based on the review of quality, safety and performance data in compliance with international standards while addressing the specific needs of low- and middle-income countries (LMICs).
Roche announced Monday that its molecular mpox assay Cobas MPXV has been listed under the World Health Organization's Emergency Use Listing (EUL) procedure.
WHO has asked manufacturers of mpox in vitro diagnostics (IVDs) to submit an expression of interest for Emergency Use Listing (EUL). WHO has been in ongoing discussions with manufacturers about the need for effective diagnostics, particularly in low-income settings. The request for EUL expressions of interest by manufacturers is the latest development in these discussions.
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The World Health Organization announced Wednesday that it has prequalified an at-home, over-the-counter assay manufactured by OraSure Technologies for hepatitis C virus.
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the World Health Organization (WHO) has awarded the cobas® HPV test prequalification designations for use on the cobas® 5800 system and for self-collected samples on the cobas® 5800, 6800 and 8800 systems. These new prequalification designations come just one month after the U.S. Food and Drug Administration approved Roche’s HPV self-collection solution and less than a year after the WHO awarded prequalification to the cobas HPV test on the cobas 6800/8800 systems.
The World Health Organization has published updated guidelines for the rapid diagnosis of tuberculosis, including new recommendations on the use of targeted next-generation sequencing (NGS) tests for drug-resistant TB.
The World Health Organization on Thursday announced that it has published a fourth edition of its essential diagnostics list (EDL) adding tests for the hepatitis E virus and recommendations related to access to personal-use glucose monitoring devices.
Roche announced that the cobas® HPV test for use on the cobas® 6800/8800 Systems has been awarded World Health Organization (WHO) prequalification. WHO prequalification expands the availability of this critical HPV screening tool in countries that rely on the global organisation’s list in making purchasing and implementation decisions.
The World Health Organization on Friday announced that COVID-19 is no longer a global emergency, marking a symbolic end to the pandemic, which has taken 7 million lives around the world. The move is deemed a natural one given the current stable situation.
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