Diasorin (FTSE MIB: DIA) today announced it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for the LIAISON PLEX® Gram-Negative Blood Culture Assay, the second of the three molecular multiplexing panels for Blood Culture identification on the LIAISON PLEX®.

Following the passage of continuing resolutions (CR) by the US Senate and the House of Representatives this week, lab test reimbursement cuts and price reporting requirements called for under the Protecting Access to Medicare Act (PAMA) are likely to be delayed one year.

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that its QIAstat-Dx syndromic testing systems and associated assays have received CE-marking under the European Union's new In-Vitro Diagnostic Medical Devices Regulation (IVDR).

PreAnalytiX GmbH, a joint venture between QIAGEN N.V. (NYSE: QGEN; Frankfurt, Prime Standard: QIA) and BD (Becton, Dickinson and Company; NYSE: BDX), today announced the launch of the PAXgene® Urine Liquid Biopsy Set, which enables the reliable analysis of cell-free DNA (cfDNA) from urine with most molecular testing technologies, including qPCR, digital PCR and next-generation sequencing (NGS). The new set will be commercialized by QIAGEN.

Cepheid announced today an important partnership with the Fleming Initiative, a global collaboration established by Imperial College Healthcare NHS Trust and Imperial College London to combat antimicrobial resistance.

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, announced today at the North American Spine Society (NASS) 39th Annual Meeting in Chicago the commercial launch of several software, hardware, and imaging innovations.

At present, the upstream raw materials of biochemical reagents mainly rely on imports. For the long-term development of the industry, the preparation technology of raw materials must be mastered.

Introduction Molecular diagnostics uses human saliva, tissue, blood, feces, urine, and other samples to detect disease-related markers and provides experimental diagnostic results for medical professionals in di..

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.