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Clinical Chemistry

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Image: LVOne uses blood-based biomarkers to detect stroke and identify large vessel occlusion before hospital arrival, providing objective results earlier than traditional assessments. (Photo courtesy of UpFront Diagnostics)

First-of-Its-Kind Rapid Blood Test Gains CE Mark to Support Prehospital Stroke Triage

Rapid stroke identification before hospital arrival is critical because treatment efficacy declines with every minute of delay. However, definitive assessment typically requires hospital-based imaging,... Read more

Molecular Diagnostics

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Image Credit: iStock

Mpox Analysis Reveals Substantial Suspected False Positives Associated with Contamination

Reliable confirmation of mpox can be difficult where multiple rash-causing illnesses co-circulate and laboratory capacity is limited. Although PCR is central to case detection, contamination during specimen... Read more

Immunology

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Image: Aptiva utilizes particle-based multi-analyte technology (PMAT) (Photo courtesy of Werfen)

Werfen Expands Automated APS Testing with FDA-Cleared and CE-Marked IgA Reagent

Antiphospholipid syndrome (APS) is an autoimmune disorder associated with thrombosis and pregnancy complications, but its symptoms can overlap with those of other conditions, complicating diagnosis.... Read more

Microbiology

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Image: Ebola remains a rapidly evolving public health threat with high mortality, underscoring the need for timely diagnosis and decentralized testing closer to patients (Image Credit: Adobe Stock)

Collaboration Targets Blood-Based Ebola Detection Outside Central Laboratories

Co-Diagnostics, Inc. (Salt Lake City, UT, USA) and ReadyGo Diagnostics Ltd. (Bath, UK) have initiated a collaboration to evaluate ReadyGo’s GoCollect with the Co-Dx PCR platform for blood-based molecular... Read more

Pathology

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Image: A new study demonstrates that vascular features in colorectal tumors could serve as prognostic biomarkers of disease outcome. (Image Credit: iStock)

Tumor Blood Vessel Features May Help Predict Colorectal Cancer Survival

Colorectal cancer outcomes vary widely, and tumor biology remains a key determinant of prognosis. Because neoplasms depend on a vascular supply, differences in intratumoral vessels may influence survival.... Read more

Technology

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Image: ADLM recommends that emerging AI tools follow the same professional oversight, quality, validation, and monitoring standards as traditional clinical testing within CLIA’s existing framework (Image Credit: Adobe Stock)

ADLM Calls for CLIA Updates to Support Safe AI Use in Laboratory Medicine

Clinical laboratories increasingly use artificial intelligence to verify, interpret, and report results, but safeguards under the Clinical Laboratory Improvement Amendments (CLIA) were designed in 1992.... Read more

Industry

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Image: Galleri is designed to detect cancer-specific methylation patterns across multiple cancer types before symptoms appear, including cancers without recommended screening (Photo courtesy of GRAIL)

Multi-Cancer Early Detection Test Wins FDA Panel Backing for Approval

GRAIL’s Galleri multi-cancer early detection (MCED) test was reviewed by the Molecular and Clinical Genetics Devices Panel of the U.S. Food and Drug Administration’s (FDA) Medical Devices Advisory Committee.... Read more
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