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.
A Labcorp survey of 148 US pathologists reports rising cancer rates are driving demand for digital pathology and genomic testing, but reimbursement and workforce shortages remain significant barriers to technology adoption.
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.
The company says its US business combines automated kit manufacturing, fulfillment, sample logistics, and digital workflow technology into a single diagnostic testing platform.
The research-use-only platform combines imaging, software, and multiplex protein analysis into a standard 96-well workflow designed to simplify biomarker research.
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.
The assay is designed to detect minimal residual disease with greater sensitivity than conventional flow cytometry.
Ozelle has introduced the O-Cyte 1, an AI-powered hematology analyzer with image-based morphology, at ADLM 2026. The system processes up to 360 tests per hour and is designed to improve lab efficiency, according to the company.
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.
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.
A Quest Diagnostics study of 1.5 million women found those with bacterial vaginosis are over three times more likely to have a non-viral STI, highlighting the need for comprehensive diagnostic testing.
Co-Diagnostics has submitted a Dual 510(k) and CLIA waiver application to the FDA for its PCR-based flu and RSV test, aiming to enable point-of-care use on the Co-Dx PCR Pro instrument.
The cobas liat system delivers PCR results in 15 minutes, detecting and differentiating between three Bordetella pathogens including whooping cough.
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.