Roche Receives CE Mark for Alzheimer’s Disease Blood Test
Roche has received CE mark approval for its Elecsys pTau217 blood test, designed to aid in Alzheimer’s disease diagnosis by detecting amyloid pathology in patients with cognitive decline.
Category: Company News
Company News
Latest
Company News
Latest
Illumina Partners with Florida State University Lab for Rare Disease Genome Sequencing
Illumina will provide clinical sequencing services to Florida State University’s new Diagnostic Lab for Pediatric Rare Diseases, aiming to accelerate rare disease diagnostics for an estimated 30 million affected Americans.
Company News
Latest
FDA Grants Breakthrough Status to Blood Test to Distinguish Schizophrenia and Bipolar Disorder
The mRNA-based test aims to provide objective data to help clinicians distinguish between psychiatric conditions that often share symptoms.
FDA Grants Breakthrough Status to Liquid Biopsy for Liver Cancer Monitoring
TCM Biotech has received FDA Breakthrough Device Designation for CatCHimera, a liquid biopsy platform for monitoring minimal residual disease in hepatocellular carcinoma using HBV–host genome integration biomarkers.
Read More
Labcorp Launches Companion Diagnostic for Ovarian Cancer Treatment
Labcorp has launched nationwide testing with Agilent’s FDA-approved PD-L1 IHC 22C3 pharmDx, enabling identification of patients with platinum-resistant ovarian cancer eligible for pembrolizumab immunotherapy.
Read More
Saladax Biomedical and Thermo Fisher Scientific Partner on Global Distribution of Drug Monitoring Assays
The agreement aims to increase the availability of therapeutic drug monitoring tests for psychiatry and oncology patients using existing laboratory equipment.
Read More
ViewsML Raises $4.9 Million for AI-Based Virtual Tissue Staining
The seed funding will support the commercialization of a platform designed to generate biomarker insights from pathology images without laboratory staining.
Read More
QuidelOrtho Completes Acquisition of LEX Diagnostics and Molecular Testing Platform
The $100 million deal brings an ultra-fast system for respiratory viruses to QuidelOrtho’s point-of-care portfolio.
Read More
Labcorp’s FDA-Cleared Rapid Fentanyl Urine Test Launches
The FDA has cleared Labcorp’s rapid fentanyl urine test, which detects norfentanyl and delivers results in 10 minutes for use in CLIA-certified labs, according to the company’s press release.
Read More
GeneCentric Data Suggest Fragmentomics Could Expand Liquid Biopsy Beyond Mutation Testing
Presentations at AACR 2026 will showcase fragmentomics-based technology for detecting therapeutic markers and providing prognostic insight.
Read More
New Light Scattering Detector Improves Characterization of Large Molecules
The system offers faster run times and reduced sample consumption for the analysis of viral vectors, protein aggregates, and advanced materials.
Read More
Biognosys and Michael J. Fox Foundation Partner to Develop Parkinson’s Disease Biomarkers
The collaboration focuses on creating sensitive assays for a common genetic risk factor to guide drug development and clinical trials.
Read More
Thermo Fisher Scientific and PRECISE Partner on Singapore Proteomics Study
The collaboration will use multi-omic platforms and AI-driven analytics to identify disease patterns and improve patient stratification within the PRECISE-SG100K study.
Read More
Labcorp and Children’s Hospital of Philadelphia Partner to Expand Pediatric Diagnostic Access
The collaboration aims to create an innovation pipeline for specialized pediatric tests across oncology, metabolic disease, and autoimmune conditions.
Read More
Autonomous Robotic Phlebotomy Shows High Success Rates in Multicenter Trial
A multicenter trial published in Clinical Chemistry reports Vitestro’s autonomous phlebotomy system achieved a 94.5% first-stick success rate, with low hemolysis and adverse event rates, in routine clinical settings.
Read More
SPT Labtech and EMBL GeneCore Partner to Advance Automated Genomics Workflows
The collaboration focuses on implementing a liquid handling platform to streamline end-to-end laboratory processes and protocol development.
Read More
CE Mark Granted for Rapid Bacterial vs Viral Infection Test
The high-throughput host-response assay provides results in approximately 20 minutes to help guide treatment decisions and antimicrobial stewardship.
Read More
Roche Receives CE Mark for Multiple Sclerosis Blood Test
The Elecsys NfL test measures a protein associated with nerve cell injury to monitor disease activity in patients with relapsing remitting multiple sclerosis.
Read More