The US Food and Drug Administration said Tuesday that it plans to reclassify several types of qualitative and quantitative hepatitis B virus (HBV) tests as moderate risk Class II devices from their current classification as high-risk Class III devices.

New TAGS (Temperature-Activated Generation of Signal) technology enables up to 15 targets to be detected simultaneously in a single patient sample on the high throughput molecular diagnostic analysers cobas 5800, 6800 and 8800.

Bio-Rad Laboratories announced Friday that it has formed a partnership with Sysmex America to offer Bio-Rad's quality control software with Sysmex's hemostasis analyzers for coagulation testing.

I. Health Resources 1. Total Number of Medical and Health Institutions By the end of 2023, the total number of medical and health institutions nationwide reached 1,070,785, an increase of 37,867 co..

YHLO's Revenue Surges 52.28% in H1 2024 As of the first half of 2024, the business of YHLO Biotech has covered more than 110 countries around the world, and the revenue of overseas non-COVID-related busin..

Thermo Fisher Scientific, headquartered in Massachusetts, announced that it will open a new bioanalytical laboratory in GoCo Health Innovation City, located in Gothenburg, Sweden. The new building, situated adjacent to AstraZeneca's key research location, will improve the company's laboratory services.

Agilent Technologies Inc. (NYSE: A) today announced the company has completed its acquisition of BIOVECTRA, a Canada-based contract development and manufacturing organization (CDMO) that specializes in biologics, highly potent active pharmaceutical ingredients, and other molecules for targeted therapeutics.

MGI Tech Co., Ltd. (“MGI”), a company committed to building core tools and technologies that drive innovation in life science, has just formed a strategic alliance with Dasa, the largest medical diagnostics company in Latin America, to expand Brazilian patients' access to next-generation genomics and promote significant advancements in Brazil's healthcare sector.

Quest Diagnostics (NYSE: DGX), the world's leading provider of diagnostic information services, and Sentara Health Plans, the health plan division of Sentara Health, an integrated, not-for-profit health care delivery system, today announced a multi-year strategic collaboration designed to expand access to high-quality, affordable and comprehensive laboratory testing for members of Sentara Health Plans.

Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, and OPKO Health, Inc. (Nasdaq: OPK), a multinational biopharmaceutical and diagnostics company, announced today the completion of Labcorp's acquisition of select assets of BioReference Health, a wholly owned subsidiary of OPKO Health.

Sysmex Inostics said Tuesday that it has secured New York State Department of Health approval for clinical trial use of the firm's liquid biopsy assay for biomarkers that are relevant for the treatment of multiple cancer types.

LuminUltra, the global leader in applied molecular diagnostics, today announced the acquisition of the legionella testing business assets of Genomadix Inc, along with rights to develop and commercialize further assays and test methods in water, energy and food and beverage markets globally using the Genomadix Cube™ qPCR (quantitative polymerase chain reaction) Platform.

Seegene Inc., a leading provider of total solution for PCR molecular diagnostics based in South Korea, announced today that it will introduce a new type of research-use-only (RUO) PCR assay to address the spread of the mpox virus variant, Clade Ib, which is currently prevalent in Africa.

n the face of the escalating mpox outbreak, health authorities worldwide are on high alert, particularly with the emergence of the more contagious and aggressive clade Ib. The surge in cases has intensified the need for rapid and accessible diagnostic tools to curb the spread of the virus.

Agappe Diagnostics Ltd., India’s leading In Vitro Diagnostics (IVD) manufacturer, has announced its partnership with Fujirebio Holdings Inc. of Japan to unveil the first “Make in India” In-Vitro Biomarkers using CLEIA (Chemiluminescent Enzyme Immunoassay) technology.