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.

Sinopia Biosciences, Inc., a biotechnology company advancing novel therapeutics identified using its proprietary LEADS® drug discovery platform, announced today it has been awarded a research grant from the National Institute of General Medical Sciences (NIGMS), part of the National Institutes of Health (NIH), to further advance its data-driven drug discovery capabilities.

Biobeat Technologies, Ltd., developer of the first FDA-cleared, 24-hour ambulatory blood pressure monitoring (ABPM) system that is a patch-worn, cuff-less solution for diagnosis and treatment of hypertension, announced today the closing of a $50 million Series B equity financing.

Blood Coagulation Analyzer and Reagents 1. Overview of Domestic Blood Coagulation Market Conventional thrombosis and hemostasis diagnostic applications are mainly concentrated on screening for bleeding dis..

Italian in vitro diagnostics firm Diasorin said on Sunday that the US Food and Drug Administration has issued 510(k) clearance and CLIA-waived the firm's first assay for use on the Liaison Nes platform.

The EU's Unified Patent Court last week ruled in favor of Myriad Genetics in its patent dispute with South Korean firm GXD-Bio.

Applied BioCode said on Monday that is has submitted a new nucleic acid extraction claim for its BioCode Respiratory Pathogen Panel (RPP) to the US Food and Drug Administration, with the goal of expanding use of the panel by clinical laboratories.

Following decades of cumulative efforts, a number of infectious disease tests and technologies broke new ground in 2025, hinting at rapid advances in the development of new systems and assays.

Chinese molecular diagnostics and precision medicine firm GenePlus Technology said on Sunday that it has filed for an initial public offering on the Hong Kong Stock Exchange.

MGI Tech Partners with Cenglang Biotechnology to Deepen Expansion in the Asia-Pacific Region On December 26th, Beijing Cenglang Biotechnology Co.,Ltd. and MGI Tech reached a strategic cooperation agreemen..

Chinese molecular diagnostics and precision medicine firm GenePlus Technology said on Sunday that it has filed for an initial public offering on the Hong Kong Stock Exchange.

Singlera Genomics said on Tuesday that it has entered into a research and distribution agreement with EU-based international medical company Pure Medical for its cell-free DNA detection products

Zydus Lifesciences said on Friday that it has signed an agreement to exclusively commercialize a trio of Myriad Genetics cancer tests in India.

Guardant Health Japan said Monday that it has received approval from that country's Ministry of Health, Labour, and Welfare (MHLW) for its Guardant360 CDx as a companion diagnostic for identifying ESR1 mutations in breast cancer patients.

3.6 Construction of Quality System The standardization and quality control of thrombus and hemostasis testing methods is to perform reasonable management, testing, and assessment of the quality level of the tech..

Sansure Biotech and Health-100 Form Strategic Partnership to Advance Quantified, Precision Health Management On December 19, 2025, Sansure Biotech and Health-100 signed a strategic cooperation agreement in Shang..

Results of a Phase I clinical trial published on Tuesday demonstrate that Personalis' minimal residual disease (MRD) assay, NeXT Personal, accurately predicts immunotherapy response across multiple metastatic solid tumor cancer types.

Singlera Genomics and its partner Breakthrough Genomics this week announced a research collaboration with the University of Pittsburgh around the early detection of pancreatic cancer.

The test stems from findings by CUHK investigators — who recently cofounded MicroSigX as a spinout of the university — that certain gut microbial community features are associated with autism spectrum disorder and could be used to diagnoses the condition.

Solvd Health said Wednesday that its pharmacogenomics (PGx) test PreScript has received approval from the New York State Department of Health Clinical Laboratory Evaluation Program (CLEP).