On 10 July 2025, the World Health Organization (WHO) prequalified the first bundled set of three in vitro rapid diagnostic tests (RDTs) capable of simultaneously detecting HIV, hepatitis B virus (HBV) and syphilis – three major infections that pose serious risks to maternal and child health.

Trinity Biotech plc (Nasdaq: TRIB), a commercial-stage biotechnology company focused on human diagnostics and diabetes management solutions, including wearable biosensors, today announced it has received World Health Organization (WHO) approval for the offshored and outsourced upstream manufacturing activities of its high-volume TrinScreen™ HIV rapid test, a cornerstone diagnostic product used in HIV screening programs. This regulatory approval marks a critical milestone in the Company’s comprehensive transformation plan aimed at restoring financial performance and driving sustainable profitability.

The World Health Organization on Thursday issued the first global guidelines for meningitis diagnosis, treatment, and care.

bioMérieux, a company specializing in in vitro diagnostics, announced the launch of GENE-UP TYPER, a real-time PCR solution for rapid pathogen detection root cause analysis in the food industry.

The World Health Organization (WHO) has achieved a milestone by approving the addition of a packaging and shipping site for a WHO prequalified HIV rapid test for professional use. This landmark approval enables the test to be procured by governments across Africa and major international organizations, such as the Global Fund and the President’s Emergency Plan for AIDS Relief (PEPFAR).

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.

Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.

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.