Werfen Gains US FDA Clearance and CE Mark for Aptiva APS IgA Reagent
The regulatory approvals complete the company’s antiphospholipid syndrome testing portfolio for IgA, IgG, and IgM on its automated multi-analyte platform. Werfen announced that its Aptiva...
View ArticleCombining p-tau217 Blood Tests with APOE4 Genotyping Forecasts Alzheimer’s...
Columbia University researchers report elevated plasma p-tau217 combined with APOE4 genetic testing predicts cognitive symptom onset within three to four years in asymptomatic individuals. Combining a...
View ArticleHealth Canada Approves Blood-Based Neurology Assays for Lumipulse Platform
Class II Medical Device Licenses cover Fujirebio tests for neurofilament light chain and phosphorylated tau 217. Health Canada has granted Class II Medical Device Licenses for the Lumipulse G NfL...
View ArticleResearchers Develop Rapid Blood Screening Method for Early Liver Disease...
The patent-pending assay measures changes in red blood cell membrane rigidity to identify elevated bile acids, a potential early marker of liver disease. Researchers at the University of Toledo...
View ArticleStudy Finds Performance Variation Among Commercial Alzheimer’s Blood Tests
The CLEAR-AD study highlights the need for platform-specific calibration for plasma p-tau217 assays to ensure diagnostic accuracy. The Clinical Evaluation of Blood-Based Tests for the Rapid...
View ArticleBRAINBox Solutions Secures Funding for Point-of-Care Concussion Testing
The financing will support the development of laboratory and point-of-care devices for the diagnosis and prognosis of traumatic brain injuries. BRAINBox Solutions announced strategic financing to...
View ArticleNIH Grant Supports Development of Rapid Chairside Oral Cancer Test
The noninvasive test uses an oral swab to measure peptide ratios, aiming to reduce unnecessary biopsies and improve diagnostic access. A research team led by Case Western Reserve University is...
View ArticleVolition Lateral Flow Prototype Correlates with Automated Sepsis Assay
Study results show finger-prick lateral flow prototype matches performance of automated nucleosome measurement in critically ill patients. VolitionRx Limited announced that results from its lateral...
View ArticleAlzheimer’s Blood Tests Found Effective for Patients with Down Syndrome
Research indicates that two widely used diagnostic tests can accurately detect amyloid pathology in a high-risk population often excluded from clinical trials. Scientists at the University of Southern...
View ArticleImmunoassays May Underestimate HbA1c in Patients with Sickle Cell Trait
Research presented at ADLM 2026 suggests high-performance liquid chromatography provides more accurate diabetes screening for populations with hemoglobin variants. People with sickle cell trait may...
View ArticlePictor Unveils High-Resolution Protein Analysis Platform at ADLM 2026
The research-use-only platform combines imaging, software, and multiplex protein analysis into a standard 96-well workflow designed to simplify biomarker research. Pictor Holdings introduced its...
View ArticleAlamar Gains Rights to Develop Clinical Alzheimer’s Blood Tests Using ALZpath...
The expanded agreement gives Alamar commercial rights to ALZpath’s pTau217 antibody for in vitro diagnostic assays, extending the collaboration from research-use tests to clinical diagnostics. ALZpath...
View ArticleNanoSomiX and Beckman Coulter Partner to Develop Blood Tests for Brain Diseases
The collaboration aims to develop automated tests that use blood samples to detect signals of neurological conditions. NanoSomiX and Beckman Coulter Diagnostics have entered a collaboration to explore...
View ArticleBlood Test Detects Aggressive Prostate Cancer More Accurately Than PSA in...
A study of more than 12,000 men found that the blood-based test reached 90% sensitivity, identifying more high-grade cases than traditional screening. A3P Biomedical announced the publication of a...
View ArticleStudy Supports Multi-Omic Blood Test Strategy for Ovarian Cancer Detection
Researchers identified coordinated lipid, metabolite, and protein signatures in symptomatic patients, supporting a multi-omic strategy for earlier ovarian cancer detection. AOA Dx announced the...
View ArticleAnthem to Cover Quanterix’s LucentAD Complete Alzheimer’s Blood Test
The insurer will provide coverage for the multi-analyte test starting July 2026, following new data showing parity with mass spectrometry. Anthem Blue Cross and Blue Shield will begin providing...
View ArticleRoche Receives CE Mark for Tuberculosis Blood Test
The automated assay identifies latent infections in routine laboratory settings with results available in less than 24 hours. Roche announced that its Elecsys IGRA TB test has received the CE Mark,...
View ArticleRoche to Share New Data on Elecsys Alzheimer’s Blood Tests at AAIC
Presentations will evaluate the performance of the company’s pTau217 and pTau181 assays while also highlighting phase 3 clinical research for the investigational therapy trontinemab for Alzheimer’s...
View ArticleFirst Commercial Alzheimer’s Tau Tangle Blood Test Launches
The eMTBR-Tau assay measures tau tangle pathology in blood, with potential applications in Alzheimer’s disease staging, clinical trials, and therapy monitoring. Alamar Biosciences has launched the...
View ArticleLilly to Present Data Comparing P-Tau217 Blood Tests With Amyloid PET at AAIC
Presentations at the upcoming Alzheimer’s Association International Conference include data comparing P-tau217 blood biomarker tests with amyloid PET, along with new long-term safety findings for...
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