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..

Original from: Burning Rock Burning Rock Biotech Limited (NASDAQ: BNR, the “Company” or “Burning Rock”), a company focused on the application of next generation sequencing (NGS) technology in the fie..

Personalized, one-on-one health coaching is now available for purchase on questhealth.com. Made available by Pack Health®, a Quest Diagnostics (NYSE: DGX) company that provides evidence-based patient engagement services, questhealth.com's Health Coaching pairs individuals with board-certified health advisers who provide personalized support, resources, and education focused on the individual's unique health goals.

A. Menarini Diagnostics announces an exclusive Distribution Agreement with Sinocare to register, promote, distribute, and market a new Sinocare 3rd Generation Continuous Glucose Monitoring (CGM) System within reimbursed markets. This landmark agreement grants A. Menarini Diagnostics exclusive rights to introduce this health technology to more than 20 jurisdictions in Europe.

1.5 Sequencer with the Highest Throughput In 2020, the DNBSEQ-T7 Gene Sequencer of Wuhan MGI Technology Co., Ltd. (hereinafter referred to as “MGI”) was approved (Registration No.: G.X.Z.Z. 20,203,220,061). It..

Roche Diagnostics Partners with Sanya Yazhou Bay Science and Technology City to Launch Public Innovation Platform for Bioscience Diagnostics On November 18, Roche Diagnostics China and the..

The US Food and Drug Administration has issued its anticipated guidance for drug and device makers on the use of circulating tumor DNA tests in clinical trials of drugs for early-stage cancer, embracing the increasingly widespread use of these tests to genotype patients as well as their emerging value to enrich trials by identifying patients more likely to benefit from adjuvant or neoadjuvant treatment.