WHO invites mpox test makers for emergency review to speed up access

GENEVA – The World Health Organisation (WHO) on Aug 29 sought to speed up the access to diagnostic tests for mpox by asking manufacturers to submit their products for an emergency review.

The agency has been in discussions with manufacturers about the need for effective diagnostics, particularly in low-income groups.

To expand access to diagnostic services urgently, the WHO has called for submissions from manufacturers for Emergency Use Listing that would allow it to approve medical products such as vaccines, tests and treatments.

The process aims to assist countries to procure the critically needed products such as tests through UN agencies and other partners.

A new form of the virus has triggered global concern as it seems to spread easily though routine close contact, prompting the health agency to declare mpox a global public health emergency earlier in August.

Sweden and Thailand have confirmed cases of the clade Ib type of the virus, outside of the Democratic Republic of Congo and neighbouring countries.

With as many as 1,000 suspected cases reported in the Congo alone this week, the need for diagnostic tests has surged dramatically, the agency said.

In the coming weeks, it will deliver another 30,000 tests to African countries.

The WHO has updated its diagnostic testing guidance to detect the new virus strain and is working with countries to roll it out.

Manufacturers of in-vitro diagnostics have been asked to provide available data on the quality, safety and performance of the tests to the WHO as soon as possible.

Earlier this week, diagnostics firm Labcorp said it was working with US health regulators to determine if it needed to ramp up its mpox testing capacity.

Swiss drugmaker Roche is actively working to enhance laboratory testing capacity for mpox worldwide. REUTERS