Clinical Microbiology
Wound Pathogen Panels: Interpreting Polymicrobial Results in Practice
A wound pathogen panel can return a crowded result before a traditional culture has finished its first meaningful round of incubation.
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Laboratory Operations
Specimen rejection criteria: managing preanalytical lab risks
The cost of error in molecular diagnostics is front-loaded. Before a single nucleic acid is amplified or a sequencing run…
Precision Medicine
DNA-Negative Driver Fusions: Adding Reflex RNA-Seq
In a clinical dataset of approximately 80,000 samples spanning 20 cancer types, RNA sequencing identified 29.1% of actionable…
Digital Pathology & AI
Cloud or On-Premise Digital Pathology: Comparing Deployments
A single whole-slide image scanned at diagnostic magnification can consume between 1 GB and 5 GB of storage. Multiply that by a…
Molecular Diagnostics
FFPE Deamination Artifacts: A False Mutation Case
There is a call that comes across my desk with numbing regularity. A tumor-only NGS run finishes in the late afternoon, the…
Laboratory Operations
IQCP Risk Assessment: Inside Custom Lab Quality Plans
Quality control in a non-waived clinical lab is one of those things everyone nods about in policy meetings and almost nobody…
Precision Medicine
HRD Score Discordance: What Assays Really Measure
A procurement committee reviewing companion-diagnostic platforms this quarter faces an inconvenient arithmetic. Across 20…
Clinical Microbiology
Mycoplasma Genitalium Reflex Testing: Protocol Next Steps
A positive Mycoplasma genitalium result is no longer the end of the diagnostic question. In many laboratories, it is the point at…
Digital Pathology & AI
Foundation Models vs Narrow AI in Digital Pathology
The central problem in pathology AI is no longer whether a model can recognize a pattern on a slide. Many models can do that. The…
Molecular Diagnostics
Amplicon Carryover: Anatomy of a Multiplex PCR Error
A single aerosolized droplet, invisible to the unaided eye and measured in femtoliters, is sufficient to corrupt an entire batch…
Laboratory Operations
MolDX Z-Codes: Inside the Molecular Test Registry
A molecular test can be analytically sound, clinically useful, and fully operational in the laboratory—and still create…
Precision Medicine
DPYD Testing in Chemotherapy: Why Lab Consensus Shifted
I keep a sticky note on the side of my monitor that reads, simply: "Cycle 1, Day 1." It is a reminder, written for myself during…
Clinical Microbiology
Genotypic Resistance Assays: Can They Replace Standard AST?
Genotypic resistance assays are fast, focused, and very good at answering one narrow question: does this specimen contain a known…
Digital Pathology & AI
Automated Blur Detection: Daily WSI Quality Control
The uncomfortable arithmetic of whole slide imaging begins with a two-digit number that laboratory directors have, for nearly a…
Laboratory Operations
Enterprise LIS or Specialized Molecular LIMS: Two Strategies
Two of the largest academic molecular pathology operations in the United States spent years and millions of dollars building…
Precision Medicine
CHIP Mutations Mistaken for Actionable Tumor Drivers
I've been thinking about a particular bench scenario that keeps surfacing in conversations with colleagues, and it bothers me in…
Digital Pathology & AI
Attention Pooling in Gigapixel Slide Analysis
A whole-slide image isn't a picture. It's a problem. One H&E slide from a routine prostate biopsy can hit 100,000 by 100,000…
Laboratory Operations
CLIA Competency Assessment for High-Complexity Labs
I want to start with a scene that plays out in high-complexity labs more often than anyone wants to admit. A tech you've known…
Precision Medicine
Broad CGP vs Targeted Hotspot Panels in Oncology
The central mistake in oncology assay selection is treating genomic breadth as a virtue in itself. It is not. A broad…
Clinical Microbiology
C. Difficile Diagnostics: A Case of PCR Overdiagnosis
A positive nucleic acid amplification test does not, by itself, establish active Clostridioides difficile infection. That…
Digital Pathology & AI
Stain Normalization: How Algorithms Standardize Slides
A whole-slide imaging program can have excellent scanners, validated classifiers, and experienced pathologists—and still produce…
Molecular Diagnostics
Multiplex PCR Panels: Clinical Impact and Real Utility
A randomized controlled trial published in JAMA Network Open in 2024 found that emergency department patients with suspected…
Laboratory Operations
Specimen Chain of Custody: Fixing Preanalytical Lab Risks
Between 60% and 70% of all laboratory errors originate in the preanalytical phase — the operational interval that begins with…
Precision Medicine
Liquid Biopsy or Tissue Testing for First-Line Therapy?
Turnaround time is a cost center. In advanced non-small-cell lung cancer, published clinical data demonstrate that plasma ctDNA…
Clinical Microbiology
MALDI-TOF Mass Spectrometry Errors: A Diagnostic Case
A MALDI-TOF result can look definitive even when the organism in front of you is telling a different story.
Digital Pathology & AI
Deep Learning Slide Pipelines: How AI Processes Tissue Patches
There's a persistent fantasy in computational pathology that AI looks at a slide the way a pathologist does — holistically, all…
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