Quality, Standards & Compliance

|2 min read

Rapid Urine Test for Prostate Cancer Shows Promise for More Accurate Diagnosis

Researchers say a paper spray mass spectrometry method could help clinical laboratories distinguish prostate cancer from benign prostate conditions in seconds
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Streamlining the Journey from RUO to IVD Assay with Recombinant Antibody Reagents

Consistent, well-characterized reagents and scalable manufacturing reduce development risk and support translation of innovative assays research to clinical application
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CAP Updates Cancer Protocols with Major Breast Cancer Reporting Changes

Revisions align pathology reporting with new WHO classifications and may affect accreditation requirements for some laboratories
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Operational Readiness: The Key to Successful Change in Clinical Labs

For laboratories seeking to grow and evolve, operational readiness planning is a key investment before introducing change
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Strengthening Clinical Laboratory Supply Chains Amid Geopolitical Tensions

Geopolitical tensions are disrupting clinical laboratory supply chains, highlighting the need for strategies to strengthen resilience and manage ongoing risk
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CAP Updates Guideline to Reduce Diagnostic Errors Through Structured Case Reviews

New evidence-based recommendations encourage pathology laboratories to formalize review processes aimed at improving diagnostic accuracy and patient care
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The Overlooked Operations Challenge in Diagnostics Commercialization

Key guiding questions to help early-stage diagnostics companies build a strong operational foundation to ensure a successful launch
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Researchers Flag Standardization Gaps in Glycated Albumin Testing Methods

Comparing enzymatic, proteomics, and reference methods reveals differences that could affect how the biomarker is standardized
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AI-Generated Fake References Increasing Across Biomedical Literature, Study Finds

Study finds AI-generated fake citations are becoming increasingly common in biomedical research papers, raising new integrity concerns
|3 min read

Ensuring Compliance: How to Get AI Diagnostic Tools Approved for Clinical Practice

A regulatory roadmap for AI diagnostic tool development
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Updated |4 min read

Hantavirus: Diagnosis, Surveillance, and 2026 Outbreak Updates

The recent hantavirus outbreak is highlighting the importance of robust laboratory and surveillance systems
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The Bayesian Breakthrough: Transparent AI in Clinical Trials

FDA draft guidance on Bayesian methods is driving more transparent, data-driven clinical trial design
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Leveraging Regulatory and Best Practices as a Foundation for Scalable Clinical NGS

From validating bioinformatics platforms to finding qualified partners, there are many strategies clinical labs can adopt to stay in compliance
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