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Genomics, Proteomics, & Metabolomics

The expanded steroid menu brings the sensitivity and specificity of mass spectrometry—the diagnostic gold standard—into routine clinical laboratories.
|2 min read

Roche Expands Mass Spectrometry Menu with CLIA Moderate-Complexity Steroid Assays

The CLIA classification broadens access to advanced testing through a fully automated and standardized workflow on the cobas® i 601 analyzer
byRoche
The gut microbiota may help regulate lipids in the blood, but the details aren’t clear.
|2 min read

Gut Microbiome Connected with Heart Disease Precursor

Using metagenomic sequencing, a new study reports a gut microbiome signature associated with dyslipidemia
byAmerican Society for Microbiology
The researchers suggest that a lack of standardized sampling procedures, sample processing, and different analysis workflows used by testing companies may contribute to these discrepancies.
|3 min read

Direct-to-Consumer Gut Microbiome Testing Kit Results Vary Between Kits and Manufacturers

The accuracy of gut health tests remains uncertain and no study has systematically evaluated their performance until now
byMiriam Bergeret, MSc
Hero
|1 min read

Standardizing Oncology Assays: A Guide to Cell Line-Derived Reference Materials

Identify the limitations of patient tissue controls in genetic testing and examine the verification data supporting cell line-derived standards
byRevvity
Sponsored by
Hero
|1 min read

Move Past the Limitations of Synthetic Reference Standards in Cancer Research

A review of cell line-derived reference standards for the investigation and molecular profiling of myeloid malignancies
byRevvity
Sponsored by
The draft guidance focuses on therapies that target a specific genetic, cellular or molecular abnormality and are designed to correct or modify the underlying cause of disease.
|3 min read

FDA Fast-Tracks Ultra-Rare Therapies with Plausible Mechanism Guidance

Framework enables approval of individualized genome editing and RNA-based treatments when traditional trials aren’t feasible
byU.S. Food and Drug Administration
The kit is intended to support research workflows that seek to better understand the biological mechanisms underlying disease by connecting genetic variation, gene expression, and protein-level activity.
|2 min read

Thermo Fisher Launches All-in-One Kit for Sequential DNA, RNA and Protein Extraction

Integrated solution simplifies multi-layer molecular analysis, advancing precision medicine and translational research
byThermo Fisher Scientific
Once largely confined to oncology, CDx is rapidly becoming a foundational pillar of precision medicine, enabling clinicians to match the right therapy with the right patient at the right time.
|3 min read

The Future of Companion Diagnostics: A Multi-Omics Revolution

The landscape of companion diagnostics is poised for transformative growth, driven by technological innovation, expanding therapeutic applications, and evolving regulatory support
byMadhuri Hegde, PhD, FACMG
While histologic examination and immunohistochemistry remain the foundation of cancer diagnosis, the authors explain that molecular profiling can provide critical additional insight when conventional approaches fall short.
|2 min read

CAP Highlights Molecular Testing to Clarify Difficult-to-Classify Tumors

CAP authors outline how genomic, transcriptomic, and epigenetic profiling can support pathologists when conventional histology and immunohistochemistry fall short, particularly in cancers of unknown primary
byCollege of American Pathologists
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Bridging Vision and Execution: A Candid Conversation on the Future of the Laboratory

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Your Model From Our Experience: Cloud First Digital Pathology in a High-Volume Regional Laboratory  

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A clinician holds a AI chip surrounded by digital healthcare icons, representing the use of artificial intelligence in clinical diagnostics

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

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Cutting-Edge Gastrointestinal Pathogen Testing Technologies for Labs

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