Category: Diagnostic Technologies

Diagnostic Technologies

FDA Clears Alzheimer’s Blood Test for Adults as Young as 40

The FDA has cleared the first blood-based Alzheimer’s test authorized for symptomatic adults as young as 40.

Diagnostic Technologies

Study Finds Performance Variation Among Commercial Alzheimer’s Blood Tests

The CLEAR-AD study found significant performance differences among nine commercial plasma p-tau217 assays for Alzheimer’s, underscoring the need for platform-specific calibration to ensure diagnostic accuracy.

Diagnostic Technologies

FDA Clears Proscia Digital Pathology Platform for New Scanner Compatibility

Proscia’s Concentriq AP-Dx digital pathology platform has received FDA 510(k) clearance for compatibility with the Leica Aperio GT 450 DX scanner and a Predetermined Change Control Plan to streamline future updates.

Anatomic Pathology

RDi USA Launches at ADLM 2026 with Automated Diagnostic Kitting Platform

The company says its US business combines automated kit manufacturing, fulfillment, sample logistics, and digital workflow technology into a single diagnostic testing platform.

Digital Pathology

Leica Biosystems Receives FDA Clearances for AI-Assisted Quality Control and Digital Pathology Scanners

Leica Biosystems received FDA 510(k) clearances for AI-assisted quality control software and two digital pathology scanners, including the first standalone tool to automate QC for digital slides in clinical workflows.

Clinical Chemistry

Immunoassays May Underestimate HbA1c in Patients with Sickle Cell Trait

Research presented at ADLM 2026 indicates immunoassays may significantly underestimate HbA1c in patients with sickle cell trait, suggesting HPLC offers more reliable diabetes screening for populations with hemoglobin variants.

Flow Cytometry

ARUP Laboratories Launches Spectral Flow Cytometry Test for Multiple Myeloma Monitoring

The assay is designed to detect minimal residual disease with greater sensitivity than conventional flow cytometry.

Hematology & Serology

National Kidney Registry to Support New Seven-Day Testing Requirements

The National Kidney Registry implemented a seven-day serology testing window for organ transplants starting Aug 10, 2026, aligning with new OPTN emergency policies and extending the timeline to all 23 serology tests.

Immunoassay

Alzheimer’s Blood Tests Found Effective for Patients with Down Syndrome

USC researchers report that two blood tests, Lumipulse G p-tau217/β-Amyloid 1-42 and PrecivityAD2, can accurately detect Alzheimer’s pathology in patients with Down syndrome.

Mass Spectrometry

SCIEX Introduces New Software and Liquid Chromatography System for Clinical Labs

SCIEX has launched the ExionLC MD system and updated SCIEX OS software, featuring workflow automation and high-performance UHPLC, to help clinical labs improve productivity, as announced at the ADLM meeting.

Microbiology

Astorg Completes Acquisition of Thermo Fisher Microbiology Business

Astorg has completed its acquisition of Thermo Fisher’s global microbiology business, establishing an independent diagnostics company. Dirk Bontridder has been named CEO.

Molecular Diagnostics

FDA Clears QIAGEN Bloodstream Infection Panel

QIAGEN has received FDA clearance for its QIAstat-Dx BCID GPF Plus AMR Panel, enabling detection of 20 pathogens and 10 antimicrobial resistance markers from positive blood cultures in about one hour.

Point-of-Care

Roche Receives FDA Clearance for Point-of-Care Bordetella Test

The cobas liat system delivers PCR results in 15 minutes, detecting and differentiating between three Bordetella pathogens including whooping cough.

Urinalysis & Toxicology

Beckman Coulter Launches DxU 1800 Automated Urinalysis System to Streamline Lab Workflows

The automated urinalysis system integrates chemistry and microscopy to help labs manage higher testing volumes and reduce manual reviews to under 3%, according to the company.