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Posts by category
- Category: Collateral
- Category: Insight
- Designing a CLIA Waiver Comparison Study for a Near-Patient Molecular Diagnostic: Where Programs Run Into Trouble (Part 2 of 2)
- PODCAST—Specimen Strategy Is Development Strategy: Why “We’ll Source It Later” Fails
- CLIA-Waived POC vs. CLIA-Waived OTC: The Intended Use Decision and What It Commits You To (Part 1 of 2)
- Semi-Quantitative Lateral Flow Assays: The Smart Middle Ground Driving the Next Wave of Diagnostic Innovation
- QMSR Is in Effect: What IVD Manufacturers Still Need to Do (Even If You Follow ISO 13485)
- PODCAST: Automation Beyond the Strip: Building Repeatable Rapid Test Production with KinBio
- PODCAST: Point-of-Care in 2025: Lateral Flow Grew Up. Where Will the Technology Go Next?
- PODCAST: The DCN Dx Model: Integration, Scale, and What Comes Next with DCN Dx CEO Charlie Mamrak
- PODCAST: Risk Management in IVD Development: A Regulatory Perspective
- Point‑of‑Care in 2025: Lateral Flow Grew Up. Where the Technology Will Go Next
- IVD Clinical Research Organization Evaluation & Comparison Rubric
- PODCAST: Predetermined Change Control Plans (PCCPs) for AI-Enabled IVDs
- Implications of FDA Predetermined Change Control Plans for AI-Enabled IVD Submissions and Future Applications
- The Foundation of Diagnostic Success: Specimen Strategy Is Development Strategy
- A 360° Approach to Aligning Clinical and Regulatory Strategy in IVD Development Overview
- Why Diagnostics Teams Outsource, and What to Expect When You Do
- Rugged by Design: Making LFA Work in the Clinic, at Home, and in Production
- Making Quantitative Work: Practical Guidance from Cytiva’s Klaus Hochleitner
- New Expert Insights Podcast Episode: Avoiding Regulatory Friction: Real Lessons from the Front Lines of IVD Clinical Trials with Sarah Barchard
- New Expert Insights Podcast Episode: Hype or Help? How to Evaluate Generative AI in Diagnostics with Jeremy Elser, Ph.D., Palantir
- Expert Insights: From Bench to Program Lead
- Advancing Lateral Flow Assay Development Through Internal R&D: DCN Dx’s Sample Adequacy Control Innovations
- Expert Insights: What the LDT Ruling Means for IVD Developers—and What to Do Now
- A Must-Watch DCN Dx Presentation from the 2025 Precision Med Tri-Conference: Regulatory Pitfalls in Diagnostic Development
- New Podcast Episode—What’s Behind Winning Regulatory Strategies for IVDs?
- New Podcast Episode—2024 Review and 2025 Predictions for Lateral Flow Diagnostics
- New Podcast Episode—Developing Your Lateral Flow Development Skills With DCN Dx’s 2025 Basic Training Course
- 2024 Year in Review and 2025 Predictions for Lateral Flow Diagnostics
- New Podcast Episode—The Hidden Costs of Cheap Lateral Flow Development: Why Experience Matters
- Navigating U.S. Market Entry for IVDs
- DCN Dx to Highlight Lateral Flow Development Services and miniDxR at MEDICA 2024
- Designing Lateral Flow Assays for Low-Resource Settings: 7 Practical Strategies for Developers
- New Podcast Episode—Unpacking the FDA’s LDT Guidance: Expert Analysis and Implications
- Advancing Point-of-Care Diagnostics: The miniDxR’s Role in Enabling High-Performance Lateral Flow Assays
- Raising the Bar in Veterinary Care: InPouch TF Bovine and TF Transit Tube as Gold Standards in Tritrichomonas foetus Detection
- The Enduring Impact of Culture Diagnostics and LFAs in STI Detection and Public Health
- Innovative Solutions for Accurate and Efficient Culture Detection of Trichomonas vaginalis and Neisseria gonorrhoeae Infections
- Lateral Flow Device Design Master Series with DCN Dx Principal Engineer, Keith Kopitzke
- Thermodynamic and Kinetic Considerations for Lateral Flow Immunoassays
- From Lab to Field: Applying Basic Lateral Flow Training to Advance Diagnostic Solutions in LMICs
- New Rules, New Approaches: Understanding the FDA’s IVD Reclassification Impact
- Reflections on ALFC 2024
- Flow Forward at ALFC 2024: Embracing Future Innovations and Collaborations in Lateral Flow
- Statistical Rigor in IVD Migration Studies: Insights from the FDA/AdvaMed Conference
- Lateral Flow Immunoassay Label Choices
- Announcing Our New Content Series, “Expert Insights: Your Gateway to World-Class Diagnostic Development and Commercialization”
- Turn! Turn! Turn! Seasonal Clinical Trials: Timely Planning and Execution for IVD Studies
- DCN Dx’s Clinical Research Services Merge the Sponsor and CRO Experience
- How Lyophilized Beads Are Revolutionizing Point-of-Care Diagnostics
- Science Meets Art in DCN Dx Lateral Flow Training Courses
- Faster and More Efficient Detection of Varicella Zoster Virus (VZV) Infections
- Developing Point-of-Use Diagnostics with Integrated Engineering
- Lateral Flow Assays, COVID-19, & Emergency Use Authorizations (EUA)
- Achieving Early Detection of HIV
- Catching Toxic Alcohol Poisoning in Time to Act
- Optimizing Natural Fertility Through Ovulation Detection
- Journal Article: “Lateral Flow Assays in Infectious Disease Diagnosis”
- Analyte Concentrations
- Selling for Scientists
- Webinar Overview: The Past, Present, and Future of Rapid Diagnostics
- The Method Comparison Experiment: A Central Requirement for New Test Methods
- Immobilizing Antibodies on Plastic Surfaces
- Recombinant Antibodies as Capture and Detection Reagents – Part 1
- Antigens, Antibodies, and Diagnostic Testing
- Contract Assay Development: Part 1
- Contract Assay Development: Part 2
- Raw Material Sourcing and Qualification for Lateral Flow Assay Development
- Understanding Whole Blood, Serum, and Plasma
- Standards, Calibrators, and Controls in Immunoassays
- Order Your Lateral Flow Supplies Online: A New Way of Doing Things at DCN Dx
- Common Assay Development Issues (And How to Avoid Them!)
- Plasma Separation: Why Do You Need It? How Do You Achieve It?
- Holistic Detective Work: The Interconnectedness of Materials and Performance in Lateral Flow
- NALF and Beyond: Lateral Flow Goes Molecular
- Make or Buy an Anitibody?
- Polyclonal Antibody or Monoclonal Antibody Selection for Lateral Flow Rapid Tests
- Antibody Seletion for Optimal Lateral Flow Assay Development
- Antibody Labeling and Analyte Detection for Lateral Flow Assays
- The Case for User-Centric Assay Design
- The Critical Components of Successful Assay Design
- DCN Dx 2018 Events Calender
- DCN Dx is Exhibiting at the 2018 ASTMH Annual Meeting
- DCN Dx is Exhibiting at the 2018 AACC Scientific Meeting
- DCN Dx is Sponsoring the 2018 Hands-On Lateral Flow Workshop
- DCN Dx is Exhibiting at the 2018 American Biomanufacturing Summit
- Lateral Flow Assays (LFAs): How Does a Lateral Flow Device Work?
- Beyond Pregnancy Tests: Current Applications of Point of Care Diagnostic Testing
- Seven Reasons why you should Consider Lateral Flow Technology for your Next Rapid Test Development Project
- DCN Dx at SLAS 2018
- DCN Dx Charitable Fund Donations 2017
- Multiplex Assays Part 2: The Power of Spot Arrays in Multiplex Assays
- Out of the Mouths of Babes
- The Multiplex Assay, Part 1: Where are all the Multiplexed LFIs?
- The Power of Collaboration in Lateral Flow: Educational Programs from DCN Dx
- Lateral Flow Assay Cassette Design: Why Do LFI Cassettes Give Problems?
- Advances in Lateral Flow Technology for Point or Care & Field-Based Applications
- Category: Podcast
- Category: Old
- Category: Press release
- Category: Testimonial
- Category: Uncategorized
- Category: Whitepaper
Products
- Blood Collection/Separation Materials Kit
- Nucleic Acid Lateral Flow Kit
- Basic Lateral Flow Training
- MICA-200C LFA Cassettes
- Lateral Flow Materials Kits
- Colloidal Gold
- Cellulose NanoBeads
- CNB Conjugation Kit
- Colloidal Gold Conjugation Kit
Case Studies
- Rescuing a Stalled Development Program for a Diagnostics Startup
- When Stopping Is the Smartest Move: How DCN Dx Helped an IVD Company Avoid Further Risk
- Securing EUA in a Compressed Respiratory Season
- Reevaluating Product Strategy After Assay Design Falls Short
- Achieving De Novo Authorization for an HCV Molecular Test—In Just Six Months
- Enhancing Sensitivity for a Non-Profit Program in LMICs
- Turning a Struggling Diagnostics Startup into a Commercial Success
- Manufacturing Solutions for an Established IVD Company
- Enhancing Sensitivity for a Non-Profit Program in LMICs