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).

Labcorp, a global leader of innovative and comprehensive laboratory services, announces it has finalized its acquisition of select outreach laboratory services from Ballad Health. The sale of these lab services, combined with Ballad Health’s ongoing strategic relationship with Labcorp, aims to enhance patient care, expand access to advanced testing and improve efficiency for the health system and its patients.

South Korean diagnostic firm Noul said Wednesday that it has inked an agreement to launch its hematology and malaria testing tools in Europe through German lab chain Limbach Group.

MeMed, a leader in the emerging field of advanced host response technologies, today announced that the FDA has granted Breakthrough Device Designation (BDD) to its innovative MeMed Severity™ test. This designation underscores the transformative potential of MeMed Severity to advance the management of patients with suspected acute infections and suspected sepsis by empowering clinicians with timely, data-driven, clinical insights.

On 5 December, Lei Haichao, Director General of China's National Health Commission (NHC), met with Saudi Health Minister Fahad Abdulrahman AlJalajel in Beijing for an in-depth discussion on enhancing bilateral health ..

Akoya Biosciences on Tuesday said it has inked an exclusive global license agreement with German molecular diagnostics firm NeraCare to develop and commercialize NeraCare’s Immunoprint test for early-stage melanoma on Akoya's immunofluorescence platform.

Agilent Technologies Inc. (NYSE: A) today announced the issuing of a Class C companion diagnostic In Vitro Diagnostic Regulation (IVDR) certification for PD-L1 IHC 28-8 pharmDx (Code SK005). This CDx assay has previously been CE-IVD–marked for sales in the European Union and is now certified in accordance with the new EU Regulation for in vitro diagnostic medical devices (IVDR) 1. PD-L1 IHC 28-8 pharmDx is approved for exclusive use with the Agilent Autostainer Link 48 advanced staining solution.

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, and MyOme, a leading clinical whole genome analysis and polygenic risk modeling company, today announced the launch of an integrated polygenic risk score (iPRS) for personalized breast cancer risk assessment. iPRS, which reports 5-year and lifetime breast cancer risk, offers individuals who receive a negative test result with Natera’s Empower hereditary cancer test the opportunity for further risk assessment using MyOme’s integrated polygenic risk score.

bioMérieux, a world leader in the field of in vitro diagnostics, today announces that its BIOFIRE® FILMARRAY® Tropical Fever (TF) Panel has received U.S. Food and Drug Administration (FDA) Special 510(k) clearance. This innovative polymerase-chain reaction (PCR) testing solution offers fast and accurate pathogen identification in patients with unexplained fever, helping to optimize treatment overall.

2. Molecular Diagnostic Reagents for Infectious Diseases 2.1 Latent Tuberculosis Infection Detection Reagents Latent tuberculosis infection (LTBI) is defined as a state of persistent immune respons..

Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, today announced that its market-leading Decipher Prostate Genomic Classifier is the only gene expression test to be included in version 1 of the 2025 NCCN* Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as part of the updated “Advanced Tools” table located in the Principles of Risk Stratification and Biomarkers section (PROS-H) .

Copan Diagnostics, a leader in microbiology laboratory innovations, is proud to announce that UriSponge®, a urine collection and transport device which uses a new formulation of advanced preservatives to ensure specimen stability for culture, has received clearance from the U.S. Food and Drug Administration (FDA). The solution offers clinical laboratories and healthcare providers a user-friendly, reliable, and cost-effective way to improve urine specimen collection, preservation, and transport.

The company says the new facility will be the “modern diagnostics production center in Europe.”

The World Health Organization (WHO) has granted prequalification to the molecular diagnostic test for tuberculosis (TB) called Xpert® MTB/RIF Ultra. It is the first test for TB diagnosis and antibiotic susceptibility testing that meets WHO's prequalification standards.

Original from: 360dx LGC on Wednesday said it has acquired DiaMex, a German manufacturer of third-party serology and molecular quality controls for clinical laboratories and blood banks, for an undisclose..