SD Biosensor, Inc. (KQ137310), a global leader in in-vitro diagnostics from South Korea, announced that its latent tuberculosis (TB) diagnostic product, STANDARD E TB-Feron ELISA (hereafter STANDARD TB-Feron), has been officially included in the World Health Organization (WHO) recommendation list for TB diagnostics. With this milestone, SD Biosensor strengthens its position in the Interferon-Gamma Release Assay (IGRA) market, marking a shift in the competitive landscape and positioning the company alongside leading global players.

To support countries in their efforts to strengthen detection of TB disease and infection, the World Health Organization (WHO) has published an updated version of the WHO operational handbook on tuberculosis: module 3:diagnosis,to accompany the WHO consolidated guidelines on tuberculosis published earlier this year. The document provides laboratory personnel, clinicians and other clinical staff, as well as ministries of health and technical partners, with detailed guidance on implementing WHO evidence-based recommendations. Furthermore, it describes operational considerations for the use of WHO-recommended tests, providing an overview of all testing classes, presenting revised model algorithms, and outlining the steps and processes required to implement and scale up new tests and testing strategies.

The World Health Organization this week issued a target product profile report for in vitro diagnostic tests to detect serious bacterial infections in newborns and babies aged 2 months and younger.

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.