Sedia Biosciences Corporation, a leading developer of innovative diagnostic tests for infectious diseases, today announced that its Asanté® HIV-1/2 Oral Fluid Test has received Pre-Qualification (PQ) status from the World Health Organization (WHO). This significant achievement enables global procurement and widespread use of this rapid diagnostic test.

On 17 December 2025, the World Health Organization (WHO) announced the prequalification of two rapid antigen diagnostic tests (Ag-RDT) for SARS-CoV-2, the virus that causes COVID-19. The two tests are the SD Biosensor STANDARD Q COVID-19 Ag Test and the ACON Biotech Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing). This marks the first time that rapid antigen tests for SARS-CoV-2 have achieved WHO prequalification.

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced that the Conformité Européenne (CE) Marked BD Onclarity™ HPV Assay for the BD COR™ System and the BD Viper™ LT System have been accepted for the World Health Organization (WHO) list of prequalified in vitro diagnostic products, further expanding access to high-quality cervical cancer screening tools in low- and middle-income countries.

Cepheid today announced that its Xpert® MTB/XDR test has been awarded prequalification status by the World Health Organization (WHO), marking a new milestone in the global fight against tuberculosis (TB). This designation affirms the test's compliance with the WHO's rigorous standards for quality, safety, and performance, and enables procurement through international agencies.

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.