# DCN Dx > DCN Dx is a Carlsbad, California-based IVD contract development and manufacturing organization (CDMO) and clinical research organization (CRO). The CDMO develops and manufactures immunoassay-based diagnostics — including lateral flow assays, ELISA, and multiplex panels — from feasibility through commercial production. The CRO provides platform-agnostic clinical study design and management, biostatistics, data management, regulatory affairs, and prospective biospecimen collection services for diagnostic developers pursuing FDA 510(k), de novo, PMA, and EU IVDR clearance. ISO 13485 and ISO 9001 certified. Headquarters: 3193 Lionshead Ave, Suite 200, Carlsbad, CA 92010. ## Services - [Services Overview](https://dcndx.com/services/): Integrated CDMO and CRO services for IVD developers. - [CDMO](https://dcndx.com/services/cdmo/): Contract development and manufacturing of immunoassay-based diagnostics. - [Contract Assay Development](https://dcndx.com/services/cdmo/contract-assay-development/): Custom lateral flow, ELISA, and multiplex assay development. - [Contract Manufacturing](https://dcndx.com/services/cdmo/contract-manufacturing/): ISO 13485–compliant IVD manufacturing. - [Aseptic Filling](https://dcndx.com/services/cdmo/aseptic-filling/): Aseptic filling services for diagnostic reagents. - [Consumable & Cassette Design](https://dcndx.com/services/cdmo/consumable-cassette-design/): Custom consumable and cassette engineering. - [Custom Readers](https://dcndx.com/services/cdmo/custom-readers/): Custom diagnostic reader design and integration. - [Clinical Validation & Regulatory](https://dcndx.com/services/cdmo/clinical-validation-regulatory/): Clinical validation and regulatory support for CDMO programs. - [CDMO Consulting](https://dcndx.com/services/cdmo/consulting/): Strategic consulting for IVD development programs. - [CRO (Clinical Research)](https://dcndx.com/services/cro-clinical-research/): Platform-agnostic IVD clinical research services. - [Trial Management](https://dcndx.com/services/cro-clinical-research/trial-management/): End-to-end IVD clinical trial management. - [Site Development](https://dcndx.com/services/cro-clinical-research/site-development/): Clinical trial site development and activation. - [Data Management](https://dcndx.com/services/cro-clinical-research/data-management/): Clinical data management for IVD studies. - [Biostatistics](https://dcndx.com/services/cro-clinical-research/biostatistics/): Biostatistical design and analysis for diagnostic studies. - [Regulatory](https://dcndx.com/services/cro-clinical-research/regulatory/): FDA, EU IVDR, and global regulatory strategy. - [CRO Consulting](https://dcndx.com/services/cro-clinical-research/consulting/): Strategic CRO consulting for IVD developers. - [Biospecimen Service](https://dcndx.com/biospecimen-service/): Prospective biospecimen collection for IVD clinical validation. - [LFA Development Services](https://dcndx.com/lfa-development-services/): Lateral flow assay development from feasibility to commercial launch. - [Regulatory Affairs Services](https://dcndx.com/regulatory-affairs-services/): End-to-end regulatory affairs for 510(k), de novo, PMA, and IVDR/MDR. ## About - [About Us](https://dcndx.com/about-us/): DCN Dx company overview, mission, and capabilities. - [Team](https://dcndx.com/about-us/team/): Leadership and scientific team. - [Facilities](https://dcndx.com/about-us/facilities/): 35,000+ sq. ft. purpose-built Carlsbad facility with BSL-2, dry room, and aseptic capabilities. - [Quality & Regulatory Compliance](https://dcndx.com/about-us/quality-regulatory-compliance/): ISO 13485 and ISO 9001 quality system details. - [Media Room](https://dcndx.com/about-us/media-room/): Press coverage and media resources. - [Careers](https://dcndx.com/about-us/careers/): Open roles at DCN Dx. - [Contact](https://dcndx.com/contact/): Contact DCN Dx. Phone: +1 760 804 3886. Email: info@dcndx.com. - [Request a Quote](https://dcndx.com/request-quote/): Request a project quote. ## Training - [Training](https://dcndx.com/training/): Hands-on lateral flow assay development training programs. - [Basic Lateral Flow Training (course page)](https://dcndx.com/store/product/basic-lateral-flow-education/): Three-day in-person Basic Lateral Flow Training course at the Carlsbad facility. ## Insights - [PODCAST — Specimen Strategy Is Development Strategy: Why "We'll Source It Later" Fails](https://dcndx.com/insights/expert-insights-podcast-biospecimen-strategy-ivd/): Expert Insights, Season 3, Episode 5. - [CLIA-Waived POC vs. CLIA-Waived OTC: The Intended Use Decision and What It Commits You To (Part 1 of 2)](https://dcndx.com/insights/clia-waived-poc-vs-otc-intended-use/): CLIA waiver describes a complexity categorization that includes defining the intended use population and user environment (Home Use vs. Point of Care). Getting those assumptions right at the intended use stage is foundational; revisiting them after the clinical program is underway is expensive and time-consuming. - [Semi-Quantitative Lateral Flow Assays: The Smart Middle Ground Driving the Next Wave of Diagnostic Innovation](https://dcndx.com/insights/semi-quantitative-lateral-flow-assays/): Semi-quantitative lateral flow assays link a positive/negative result to a meaningful concentration threshold, enabling better decisions without the cost and complexity of fully quantitative systems. DCN Dx treats semi-quantitative design as a deliberate product architecture choice aligning technical performance with real-world use cases. - [QMSR Is in Effect: What IVD Manufacturers Still Need to Do (Even If You Follow ISO 13485)](https://dcndx.com/insights/qmsr-ivd-manufacturers-gaps-iso-13485/): QMSR incorporates ISO 13485:2016 by reference, but it is not "ISO certification with an FDA logo." FDA does not require ISO 13485 certification, and certification does not exempt a manufacturer from FDA inspection. - [PODCAST: Automation Beyond the Strip — Building Repeatable Rapid Test Production with KinBio](https://dcndx.com/insights/podcast-automation-beyond-strip-building-repeatable-rapid-test-production-kinbio/): Mitzi Rettinger (CRO, DCN Dx) and Daniel Levenson (KinBio) discuss the transition from manual to automated, repeatable rapid-test manufacturing. - [PODCAST: Point-of-Care in 2025 — Lateral Flow Grew Up. Where Will the Technology Go Next?](https://dcndx.com/insights/podcast-point-care-lateral-flow-grew-up/): Mitzi Rettinger speaks with Dr. Pat Vaughan (COO, DCN Dx) on 2025 POC shifts and 2026 predictions. - [PODCAST: The DCN Dx Model — Integration, Scale, and What Comes Next](https://dcndx.com/insights/podcast-dcndx-model-integration-ivd-diagnostics-scale-charlie-mamrak/): Expert Insights conversation with CEO Charlie Mamrak, hosted by Mitzi Rettinger. - [PODCAST: Risk Management in IVD Development — A Regulatory Perspective](https://dcndx.com/insights/expert-insights-podcast-risk-management-ivd-development-regulatory-perspective/): Preventable risks that lead to delayed submissions, costly rework, and missed approvals, and how to build alignment across clinical, regulatory, and usability workstreams from the start. - [Point-of-Care in 2025: Lateral Flow Grew Up. Where the Technology Will Go Next](https://dcndx.com/insights/point-of-care-2025-lateral-flow-grew-where-technology-next/): By Pat Vaughan, Ph.D., Chief Operating Officer, DCN Dx. - [IVD Clinical Research Organization Evaluation & Comparison Rubric](https://dcndx.com/insights/ivd-clinical-research-organization-evaluation-comparison-rubric/): Structured side-by-side rubric for evaluating IVD CROs using criteria tied to clinical performance evidence, operational execution, and study integrity. - [PODCAST: Predetermined Change Control Plans (PCCPs) for AI-Enabled IVDs](https://dcndx.com/insights/podcast-predetermined-change-control-plans-pccps-enabled-ivds/): How FDA's PCCP mechanism applies to AI-enabled device software functions and iterative software updates. - [Implications of FDA Predetermined Change Control Plans for AI-Enabled IVD Submissions](https://dcndx.com/insights/fda-predetermined-change-control-plans-pccp-ivd/): Overview of FDA's PCCP framework for AI-enabled medical devices, including the recent draft guidance suggesting PCCPs may soon apply to all medical devices. - [The Foundation of Diagnostic Success: Specimen Strategy Is Development Strategy](https://dcndx.com/insights/biospecimen-strategy-development-strategy/): A foundational essay on why specimen strategy is inseparable from development strategy in IVD programs. - [A 360° Approach to Aligning Clinical and Regulatory Strategy in IVD Development](https://dcndx.com/insights/360-approach-aligning-clinical-regulatory-strategy-ivd-development-overview/): Overview of DCN Dx's integrated clinical + regulatory strategy approach. - [Why Diagnostics Teams Outsource, and What to Expect When You Do](https://dcndx.com/insights/why-diagnostics-teams-outsource-what-expect/): By Pat Vaughan, Ph.D., Chief Operating Officer, DCN Dx. - [Rugged by Design: Making LFA Work in the Clinic, at Home, and in Production](https://dcndx.com/insights/making-lfa-work-clinic-home-production/): Kellie LaRochelle (Imagene Technology) on the three design guardrails — ease of use, ruggedness, affordability — that drive real-world lateral flow reliability. - [Making Quantitative Work: Practical Guidance from Cytiva's Klaus Hochleitner](https://dcndx.com/insights/making-quantitative-work-practical-guidance-cytivas-klaus-hochleitner/): Practical guidance on moving lateral flow from qualitative to quantitative. - [PODCAST: Avoiding Regulatory Friction — Real Lessons from the Front Lines of IVD Clinical Trials with Sarah Barchard](https://dcndx.com/insights/expert-insights-podcast-avoiding-regulatory-friction-ivd-clinical-trials-sarah-barchard/): Sarah Barchard (Senior Clinical Trials Manager, DCN Dx) on common pitfalls in diagnostic programs and how to fix a struggling clinical trial before it derails a submission. - [Lyophilized Beads for Immunoassay and Molecular Diagnostics](https://dcndx.com/insights/lyophilized-beads-immunoassay-molecular-diagnostics/): Custom lyophilized beads that eliminate cold chain logistics and integrate easily into microfluidics, cartridges, or PCR tubes. - [Whitepaper: Aligning the IVD Lifecycle](https://dcndx.com/insights/aligning-ivd-lifecycle/): The five most preventable and costly sources of delay in IVD programs, drawn from DCN Dx's experience across hundreds of global submissions. - [PODCAST: Hype or Help? How to Evaluate Generative AI in Diagnostics with Jeremy Elser, Ph.D. (Palantir)](https://dcndx.com/insights/new-expert-insights-podcast-episode-hype-help-how-evaluate-generative-ai-diagnostics-jeremy-elser-ph-d-palantir/): Mitzi Rettinger and Jeremy Elser (Palantir) on how diagnostics leaders can make sense of AI's emergence in IVD. - [Expert Insights: From Bench to Program Lead](https://dcndx.com/insights/expert-insights-bench-program-lead/): Helen Hsieh (Senior Scientist & Program Manager, DCN Dx) on common development mistakes, label selection tradeoffs, and designing for manufacturability. - [Advancing LFA Development Through Internal R&D: DCN Dx's Sample Adequacy Control Innovations](https://dcndx.com/insights/lateral-flow-assay-internal-research-development-sample-adequacy-control-innovations/): In-house R&D behind sample adequacy controls for blood, urine, and saliva assays in home-use and POC settings. - [Expert Insights: What the LDT Ruling Means for IVD Developers — and What to Do Now](https://dcndx.com/insights/expert-insights-what-the-ldt-ruling-means-for-ivd-developers-and-what-to-do-now/): By Dan Simpson, RAC (US, CAN), DCN Dx. - [Regulatory Affairs Services Brochure](https://dcndx.com/insights/regulatory-affairs-services-brochure/): End-to-end regulatory affairs: 510(k), de novo, PMA, IVDR/MDR, pre-submission meetings, Breakthrough Device designation, and post-market compliance. - [DCN Dx Presentation from the 2025 Precision Med Tri-Conference: Regulatory Pitfalls in Diagnostic Development](https://dcndx.com/insights/a-must-watch-dcn-dx-presentation-from-the-2025-precision-med-tri-conference-regulatory-pitfalls-in-diagnostic-development/): Conference session on regulatory pitfalls in IVD development. - [PODCAST: What's Behind Winning Regulatory Strategies for IVDs?](https://dcndx.com/insights/blog-podcast-episode-winning-regulatory-strategies-ivds/): Mitzi Rettinger with Dan Simpson (Head of Regulatory Affairs) and Emily Friedland (VP Clinical Research). - [PODCAST: 2024 Review and 2025 Predictions for Lateral Flow Diagnostics](https://dcndx.com/insights/new-podcast-episode-2024-review-and-2025-predictions-for-lateral-flow-diagnostics/): Mitzi Rettinger and Dr. Patrick Vaughan on decentralized healthcare, AI-driven diagnostics, sustainability, and regulatory shifts. - [PODCAST: Developing Your Lateral Flow Development Skills With DCN Dx's 2025 Basic Training Course](https://dcndx.com/insights/podcast-expert-insights-lateral-flow-lfa-training-melanie-bader/): Melanie Bader (Research Scientist & Training Specialist) on the 2025 Basic Lateral Flow Training Course. - [2024 Year in Review and 2025 Predictions for Lateral Flow Diagnostics](https://dcndx.com/insights/2024-lfa-review-2025-predictions-lateral-flow/): Smartphone-based and custom stand-alone LFA readers have enabled semi-quantitative and quantitative results from traditionally qualitative assays, improving accuracy and enabling real-time data sharing for epidemiological tracking. - [PODCAST: The Hidden Costs of Cheap Lateral Flow Development — Why Experience Matters](https://dcndx.com/insights/podcast-episode-hidden-costs-cheap-lateral-flow/): Mitzi Rettinger and Dr. Pat Vaughan on the risks of working with inexperienced or low-cost LFA developers. - [Navigating U.S. Market Entry for IVDs](https://dcndx.com/insights/navigating-u-s-market-entry-for-ivds/): MEDICA 2024 talk by Dr. Patrick Vaughan on regulatory requirements, study design, and device integration for U.S. market entry. - [DCN Dx at MEDICA 2024: Lateral Flow Development Services and miniDxR](https://dcndx.com/insights/lateral-flow-development-services-medica-2024/): MEDICA 2024 announcement for DCN Dx exhibit and meetings. - [Designing Lateral Flow Assays for Low-Resource Settings: 7 Practical Strategies for Developers](https://dcndx.com/insights/designing-lateral-flow-assays-for-low-resource/): Practical LFA design strategies for LMICs where infrastructure (electricity, lab space, trained personnel) is limited. - [PODCAST: Unpacking the FDA's LDT Guidance — Expert Analysis and Implications](https://dcndx.com/insights/fda-ldt-guidance-expert-analysis-implications/): FDA's rule redefining LDTs as regulated medical devices and the implications of the Supreme Court's Chevron decision. - [Advancing Point-of-Care Diagnostics: The miniDxR's Role in Enabling High-Performance LFAs](https://dcndx.com/insights/advancing-point-of-care-diagnostics-the-minidxrs-role-in-enabling-high-performance-lateral-flow-assays/): How the miniDxR reader enables sensitivity and specificity improvements in point-of-care LFAs. - [Raising the Bar in Veterinary Care: InPouch TF Bovine and TF Transit Tube as Gold Standards in Tritrichomonas foetus Detection](https://dcndx.com/insights/tf-bovine-transit-tube-tritrichomonas-foetus/): Biomed Diagnostics tools for bovine trichomoniasis diagnosis. - [The Enduring Impact of Culture Diagnostics and LFAs in STI Detection and Public Health](https://dcndx.com/insights/culture-diagnostics-lfa-sti-detection-public-health/): National Public Health Week discussion on public health labs × diagnostic developers for STI detection. - [Innovative Solutions for Culture Detection of Trichomonas vaginalis and Neisseria gonorrhoeae](https://dcndx.com/insights/innovative-solutions-for-accurate-and-efficient-culture-detection-of-trichomonas-vaginalis-and-neisseria-gonorrhoeae-infections/): Sexually transmitted infections and the need for improved diagnostic tools that accurately detect these infections in a wide variety of clinical settings. - [Lateral Flow Device Design Master Series with DCN Dx Principal Engineer Keith Kopitzke](https://dcndx.com/insights/lateral-flow-engineering-mastery-with-dcn-dx-expert-insights/): Video series on mastering LFA design challenges in IVD. - [Thermodynamic and Kinetic Considerations for Lateral Flow Immunoassays](https://dcndx.com/insights/unlock-the-secrets-of-lateral-flow-immunoassay-design-with-thermodynamics-and-kinetics/): Dr. Kristin Cederquist on the role of thermodynamics and kinetics in LFA design — ALFC 2024 Lunch and Learn session. - [From Lab to Field: Applying Basic Lateral Flow Training to Advance Diagnostic Solutions in LMICs](https://dcndx.com/insights/applying-basic-lateral-flow-training-diagnostic-solutions-lmics/): Interview with Dr. Fezile Khumalo (University of Cape Town) on applying BLFT to LMIC diagnostic development. - [New Rules, New Approaches: Understanding the FDA's IVD Reclassification Impact](https://dcndx.com/insights/understanding-fda-ivd-reclassification-impact/): FDA reclassification of certain infectious disease IVDs from Class III to Class II and the implications for developers. - [Reflections on ALFC 2024](https://dcndx.com/insights/reflections-on-alfc-2024/): Takeaways from the 2024 Advanced Lateral Flow Conference. - [Flow Forward at ALFC 2024: Embracing Future Innovations and Collaborations in Lateral Flow](https://dcndx.com/insights/alfc2024-flow-forward/): Welcome from Mitzi Rettinger (CRO, DCN Dx) to ALFC 2024 at the Hard Rock Hotel, San Diego. - [Understanding the FDA's Latest Cybersecurity Guidance — Implications for IVD Devices](https://dcndx.com/insights/fda-cybersecurity-guidance-ivd-devices-medical/): Analysis of "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" for IVD manufacturers. - [Energetic Considerations for Particle Conjugates in Lateral Flow Immunoassays](https://dcndx.com/insights/energetic-considerations-particle-conjugates-lfa/): Whitepaper by Senior Scientist Kristin Cederquist, Ph.D. on molecular-level interactions that determine LFA performance. - [Statistical Rigor in IVD Migration Studies: Insights from the FDA/AdvaMed Conference](https://dcndx.com/insights/ivd-migration-studies-expert-insights-fda-advamed/): Veronika Atkinson (Principal Biostatistician, DCN Dx) on critical considerations for IVD migration studies. - [Improve the Interpretability of Your Lateral Flow Assay](https://dcndx.com/insights/lateral-flow-assay-lfa-image-color-grading/): Whitepaper on how lighting environments affect the accuracy and interpretability of user LFA test strip color grading. - [Lateral Flow Immunoassay Label Choices](https://dcndx.com/insights/lateral-flow-immunoassay-label-choices/): Overview of immunoassay labels — from early radioactive isotopes to modern optical and enzymatic systems — and the tradeoffs in lateral flow label selection. ## Case Studies - [Rescuing a Stalled Development Program for a Diagnostics Startup](https://dcndx.com/case-study/rescuing-a-stalled-development-program-for-a-diagnostics-startup/): A diagnostics startup came to DCN Dx after months of stalled progress, lacking documentation and a reproducible assay with the previous development partner. - [When Stopping Is the Smartest Move: How DCN Dx Helped an IVD Company Avoid Further Risk](https://dcndx.com/case-study/when-stopping-is-the-smartest-move-how-dcn-dx-helped-an-ivd-company-avoid-further-risk/): An established IVD company transferred a lagging diagnostic program to DCN Dx after losing confidence in their previous CDMO; DCN Dx guided a risk-based go/no-go decision. - [Securing EUA in a Compressed Respiratory Season](https://dcndx.com/case-study/securing-eua-in-a-compressed-respiratory-season/): A sponsor developed a multiplexed respiratory test for OTC use but faced delays that pushed the study launch into mid-respiratory-season; DCN Dx activated nine sites and adapted in-stride to meet FDA enrollment targets. - [Reevaluating Product Strategy After Assay Design Falls Short](https://dcndx.com/case-study/reevaluating-product-strategy-after-assay-design-falls-short/): A startup confident their LFA was manufacturing-ready turned to DCN Dx after pushback from their CDMO; DCN Dx led a performance, clinical value, and viability reassessment. - [Achieving De Novo Authorization for an HCV Molecular Test — In Just Six Months](https://dcndx.com/case-study/achieving-de-novo-authorization-for-an-hcv-molecular-test-in-just-six-months/): DCN Dx's Clinical Research Services (CRS) division fast-tracked a novel hepatitis C molecular point-of-care test through de novo authorization on a federal contract timeline with zero flexibility. - [Enhancing Sensitivity for a Non-Profit Program in LMICs](https://dcndx.com/case-study/enhancing-sensitivity-for-a-non-profit-program-in-lmics/): DCN Dx addressed design robustness and reagent-cost challenges to ensure field readiness for an international non-profit program. - [Turning a Struggling Diagnostics Startup into a Commercial Success](https://dcndx.com/case-study/turning-a-struggling-diagnostics-startup-into-a-commercial-success/): DCN Dx stabilized a non-reproducible point-of-care assay design and advanced it to analytical validation, positioning the client for commercialization. - [Manufacturing Solutions for an Established IVD Company](https://dcndx.com/case-study/manufacturing-solutions-for-an-established-ivd-company/): DCN Dx's early assessments identified fundamental design flaws and guided the client through a critical go/no-go decision. ## Products - [Blood Collection / Separation Materials Kit](https://dcndx.com/store/product/blood-collection-separation-materials-kit/): All-in-one kit for blood collection and RBC separation — filters RBCs without hemolysis for fingerstick blood diagnostic tests and blood sample collection devices. - [Nucleic Acid Lateral Flow Kit (NALF-D)](https://dcndx.com/store/product/nucleic-acid-lateral-flow-kit/): Generic LFA platform for detection of labeled DNA amplicons; compatible with up to 5 mM DTT (a reagent common to molecular reactions). - [MICA-200C LFA Cassettes](https://dcndx.com/store/product/cassettes/): High-performance LFA cassettes engineered for tight cassette/test-strip integration, closure design, and closure process. Sold in packs of 100 or 250. - [Lateral Flow Materials Kits](https://dcndx.com/store/product/lateral-flow-materials-starter-kit/): Complete starter kits (MATL-025 and MATL-005) with the components needed to begin LFA development in-house. - [Colloidal Gold](https://dcndx.com/store/product/colloidal-gold-lateral-flow/): Cost-effective gold colloid solution; bulk pricing and manufacturing supply contracts available (limit 3 liters per order). - [Cellulose NanoBeads (NanoAct™)](https://dcndx.com/store/product/cellulose-nanobeads/): High-performance LFA label developed by Asahi Kasei Corporation, distributed by DCN Dx. - [Cellulose Nanobead Conjugation Kit](https://dcndx.com/store/product/cellulose-nanobead-conjugation-kit/): Kit for reliable conjugations to NanoAct™ cellulose nanobeads. - [Colloidal Gold Conjugation Kit](https://dcndx.com/store/product/colloidal-gold-conjugation-kit/): Kit for optimizing protein–gold conjugates; includes particles, blocking buffer, storage buffer, and DCN Dx–recommended protocols. - [Basic Lateral Flow Training](https://dcndx.com/store/product/basic-lateral-flow-education/): Three-day in-person course in Carlsbad combining lectures with hands-on lab work. Small class size (12 attendees max). - [Products Catalog](https://dcndx.com/store/): Full DCNovations product catalog. ## Events - [MEDICA 2026](https://dcndx.com/event/medica-2026/) - [HLTH 2026](https://dcndx.com/event/hlth-2026/) - [AMP 2026](https://dcndx.com/event/amp-2026/) - [IDWeek 2026](https://dcndx.com/event/idweek-2026/) - [AAVLAD Annual Meeting 2026](https://dcndx.com/event/aavlad-annual-meeting-2026/) - [NextGen Dx 2026](https://dcndx.com/event/nextgen-dx-2026/) - [ADLM 2026](https://dcndx.com/event/adlm-2026/) - [Precision Med Tricon 2026](https://dcndx.com/event/precision-med-tricon-2026/) - [2026 Infectious Diseases Innovation Showcase](https://dcndx.com/event/2026-infectious-diseases-innovation-showcase/) - [Events Hub](https://dcndx.com/events/): Upcoming events where DCN Dx is exhibiting or presenting. ## News - [DCN Dx Announces Launch of New Prospective Biospecimen Collections Service](https://dcndx.com/news/dcn-dx-announces-launch-new-prospective-biospecimen-collections-service/): New prospective biospecimen collections offering supporting the full lifecycle of IVD product development. - [DCN Dx Announces 2026 Basic Lateral Flow Training Course Dates](https://dcndx.com/news/dcn-dx-announces-2026-basic-lateral-flow-training-course-dates/): 2026 BLFT course schedule at the Carlsbad facility. - [DCN Dx to Exhibit at MEDICA 2025 in Düsseldorf](https://dcndx.com/news/dcn-dx-exhibit-medica-2025-dusseldorf/): MEDICA 2025 exhibit, November 17–20, Düsseldorf, Germany. - [DCN Dx to Exhibit and Present at AMP 2025 Annual Meeting & Expo](https://dcndx.com/news/dcn-dx-exhibit-and-present-amp-2025-annual-meeting-expo/): AMP 2025 exhibit in Boston, November 11–15. - [DCN Dx to Exhibit at IDWeek 2025 in Atlanta](https://dcndx.com/news/dcn-dx-exhibit-idweek-2025-atlanta/): IDWeek 2025, October 19–22, Georgia World Congress Center. - [Advanced Lateral Flow Conference 2025 Releases Full Agenda](https://dcndx.com/news/advanced-lateral-flow-conference-2025-releases-full-agenda/): ALFC 2025 full agenda released for October 14–15 event at Hilton La Jolla Torrey Pines. - [Kemp Proteins CSO to Highlight Machine Learning's Role in Protein Development at ALFC 2025](https://dcndx.com/news/kemp-proteins-machine-learning-protein-alfc-2025/): Dr. Carter Mitchell (CSO, Kemp Proteins) featured talk on ML for LFA protein development. - [DCN Dx to Exhibit at NextGen Dx 2025 in Washington, DC](https://dcndx.com/news/dcn-dx-exhibit-nextgendx-2025-washington-dc/): NextGen Dx Summit 2025, August 18–20, Capital Hilton. - [DCN Dx to Exhibit at ADLM 2025 in Chicago](https://dcndx.com/news/dcn-dx-exhibit-adlm-2025-chicago/): ADLM 2025, July 29–31, McCormick Place, Booth #2055. - [Palantir's Jeremy Elser to Keynote 2025 Advanced Lateral Flow Conference](https://dcndx.com/news/palantir-jeremy-elser-keynote-2025-advanced-lateral-flow-conference-strategic-ai-diagnostics/): Jeremy Elser, Ph.D. (Palantir) keynote on strategic AI in diagnostics. - [Award Nominations Open for 2025 Advanced Lateral Flow Conference Awards](https://dcndx.com/news/award-nominations-2025-advanced-lateral-flow-conference-awards/): 2025 ALFC Awards nominations open. - [DCN Dx Launches Redesigned Website](https://dcndx.com/news/dcn-dx-launches-redesigned-website-to-improve-access-to-resources-showcase-team/): Redesigned dcndx.com with improved navigation and team showcase. - [Advanced Lateral Flow Conference 2025 Now Accepting Speaker Applications](https://dcndx.com/news/advanced-lateral-flow-conference-2025-now-accepting-speaker-applications/): ALFC 2025 speaker applications open. - [Advanced Lateral Flow Conference 2025 Now Accepting Poster Presentation Submissions](https://dcndx.com/news/advanced-lateral-flow-conference-2025-now-accepting-poster-presentation-submissions/): ALFC 2025 poster submissions open. - [DCN Dx Expands Offerings with Comprehensive Regulatory Affairs Services](https://dcndx.com/news/dcn-dx-expands-offerings-with-comprehensive-regulatory-affairs-services/): Launch of Regulatory Affairs Services for FDA and international approvals. - [DCN Dx Announces "Early Bird" Registration Rates for 2025 Advanced Lateral Flow Conference](https://dcndx.com/news/dcn-dx-announces-early-bird-registration-rates-for-2025-advanced-lateral-flow-conference/): ALFC 2025 early bird registration open. - [DCN Dx at 2025 Precision Med Tri-Conference & Expo](https://dcndx.com/news/dcn-dx-to-showcase-expertise-in-lateral-flow-cdmo-and-ivd-cro-services-at-2025-precision-med-tri-conference-expo/): Precision Med Tri-Conference, March 11–13, 2025, San Diego. - [Advanced Lateral Flow Conference Announces 2025 Dates and New Location](https://dcndx.com/news/advanced-lateral-flow-conference-announces-2025-dates-and-new-location/): ALFC 2025 moved to Hilton La Jolla Torrey Pines, October 14–15. - [DCN Dx Announces 2025 Basic Lateral Flow Training Course Dates](https://dcndx.com/news/basic-lateral-flow-training-course-dates-2025/): 2025 BLFT course schedule. - [Biomed Diagnostics to Present Research on Enhanced Tritrichomonas foetus Transport Methods for PCR Testing at AAVLD 2024](https://dcndx.com/news/aavld-2024-diagnostics-tritrichomonas-foetus-pcr/): AAVLD 2024 research comparing transport media for T. foetus detection. - [DCN Dx at IDWeek 2024](https://dcndx.com/news/idweek-2024-infectious-disease-diagnostics/): IDWeek 2024, LA Convention Center, Booth #120. - [DCN Dx to Present at the 29th ADLM International CPOCT Symposium](https://dcndx.com/news/dcndx-poster-29th-adlm-international-cpoct-symposium/): CPOCT Symposium, September 25–27, 2024, San Diego. - [DCN Dx at NextGen Dx 2024](https://dcndx.com/news/dcn-dx-showcase-new-technologies-nextgen-dx-2024/): NextGen Dx Summit 2024, August 19–21, Washington, DC, Booth 30. - [DCN Dx at ADLM 2024](https://dcndx.com/news/new-technologies-present-ivd-research-adlm-2024/): DCN Dx at ADLM 2024. - [DCN Dx's Clinical Research Helps Secure FDA Authorization for Cepheid HCV Test](https://dcndx.com/news/clinical-research-fda-cepheid-hcv-test/): FDA grants De Novo marketing authorization with CLIA Waiver for the Cepheid Xpert HCV test. - [FDA Grants EUA to Wondfo's WELLlife™ COVID-19/Influenza A&B Test Supported by DCN Dx Clinical Research](https://dcndx.com/news/fda-eua-wondfo-welllife-clinical-research/): FDA EUA for the WELLlife™ COVID-19/Influenza A&B Test developed by Wondfo USA. - [Biomed Diagnostics Presents Critical Research at ASM Microbe 2024](https://dcndx.com/news/biomed-diagnostics-presents-critical-research-at-asm-microbe-2024/): Abstract accepted at ASM Microbe 2024 on extending viability time and temperature parameters for InPouch™ TV Trichomonas vaginalis transportation. - [DCN Dx Bolsters Board with Appointment of Former Meridian Biosciences CEO Jack Kenny](https://dcndx.com/news/board-appointment-former-meridian-biosciences-ceo-jack-kenny/): Jack Kenny appointed to the DCN Dx board of directors. - [Advanced Lateral Flow Conference 2024 Agenda](https://dcndx.com/news/advanced-lateral-flow-conference-2024-agenda-now-available-for-download/): ALFC 2024 full agenda. - [Advanced Lateral Flow Conference 2024 Innovation Award Finalists Announced](https://dcndx.com/news/advanced-lateral-flow-conference-2024-innovation-award-finalists-announced/): ALFC 2024 Innovation Award finalists. - [BioMed Diagnostics at VMX 2024](https://dcndx.com/news/biomed-diagnostics-to-attend-vmx-2024/): VMX 2024 veterinary expo in Orlando. - [DCN Dx Announces Sponsorship Opportunities for 2024 ALFC](https://dcndx.com/news/sponsorship-opportunities-alfc-2024/): ALFC 2024 sponsorship opportunities. - [DCN Dx Opens Nominations for 2024 ALFC Awards](https://dcndx.com/news/advanced-lateral-flow-conference-alfc-2024-awards/): ALFC 2024 awards: Innovation, Lifetime Achievement, Leadership in Diagnostics, Poster. - [Biomed Diagnostics Fills Public Health Void Following Discontinuation of Popular STI Diagnostic](https://dcndx.com/news/biomed-diagnostics-intray-gc-sti-gonorrhea-ivd/): InTray GC filling the void left by the discontinuation of the Remel JEMBEC product. - [DCN Dx Announces ALFC 2024; Regular Registration Open](https://dcndx.com/news/alfc-2024-lateral-flow-conference-registration-open/): ALFC 2024 registration announcement (Charlie Mamrak, CEO). - [DCN Dx Announces Hire of Angela Rapattoni as VP of Finance](https://dcndx.com/news/angela-rapattoni-vp-finance-dcndx/): Angela Rapattoni joins as VP of Finance with 13+ years of finance experience. - [DCN Dx's Role in Revolutionizing Neonatal Jaundice Diagnosis with BiliDx](https://dcndx.com/news/bilidx-revolutionizing-neonatal-jaundice-diagnosis/): BiliDx point-of-care bilirubin measurement per PLOS Global Public Health publication. - [DCN Dx and BIOASTER Announce Collaboration for Multiplex Rapid Diagnostics for Neglected Tropical Diseases](https://dcndx.com/news/bioaster-collaboration-onchocerciasis-multiplex-lfa/): Collaboration with BIOASTER on onchocerciasis diagnosis, funded by the Bill & Melinda Gates Foundation. - [DCN Dx and Mapp Biopharmaceutical Announce Subcontract for Ebola Detection](https://dcndx.com/news/dcn-and-mapp-biopharmaceutical-announce-subcontract/): Subcontract with Mapp Biopharmaceutical for Ebola detection. - [PortaCheck Releases New Device for Subclinical Mastitis Detection](https://dcndx.com/news/portacheck-releases-subclinical-mastitis-reader/): PortaCheck (a DCN Dx brand) launches the PortaReader™ for bovine subclinical mastitis. - [DCN Dx Acquires Biomed Diagnostics](https://dcndx.com/news/dcn-dx-acquires-biomed-diagnostics-microbiology-ivd/): Acquisition of Biomed Diagnostics, a microbiological testing products company (White City, OR). - [DCN Dx Hosts Career Fair and Open House at New Carlsbad Facility](https://dcndx.com/news/dcn-dx-host-open-house-career-fair-new-facility/): Open house and career fair at 3193 Lionshead Ave, Suite 200, Carlsbad. - [DCN Dx Partners with Mainz Biomed on Clinical Studies for Colorectal Cancer Product](https://dcndx.com/news/dcn-dx-partners-mainz-biomed-ivd-clinical-research/): Clinical studies for novel mRNA biomarkers in Mainz Biomed's ColoAlert product. - [DCN Dx Announces Hiring of Mitzi Rettinger as Chief Revenue Officer](https://dcndx.com/news/dcn-dx-announces-hiring-mitzi-rettinger-chief-revenue-officer/): Mitzi Rettinger joins as CRO, reporting to CEO Charlie Mamrak. - [Atom Bioworks Wins 2021 Rapid Testing Innovation Award](https://dcndx.com/news/atom-bioworks-wins-rapid-testing-innovation-award/): ALFC 2021 Rapid Testing Innovation Award. - [DCN Dx Acquires IVD Vision](https://dcndx.com/news/dcndx-acquires-ivd-vision-diagnostics-company/): Acquisition of IVD Vision, Inc., a developer of custom instruments and software for diagnostics systems. - [DCN Dx Acquires PortaScience](https://dcndx.com/news/dcndx-acquires-portascience-portacheck-dry-chemistry/): Acquisition of PortaScience, Inc., a dry-chemistry-focused POC diagnostics company. - [Brendan O'Farrell Featured in The Currency](https://dcndx.com/news/brendan-ofarrell-featured-the-currency/): DCN Dx President and Founding Partner Brendan O'Farrell, Ph.D., featured in The Currency. - [DCN Charitable Fund 2020](https://dcndx.com/news/dcn-charitable-fund-2020/): DCN Charitable Fund 2020 update. ## Legal - [Terms & Conditions of Use](https://dcndx.com/terms-conditions-of-use/): Website terms of use. - [DCN Dx Standard Terms and Conditions](https://dcndx.com/service-t-c/): Standard terms and conditions for DCN Dx client proposals and services. - [DCNovations Products & Services Terms & Conditions](https://dcndx.com/dcndx-products-services-terms-conditions/): Terms for purchase of DCNovations products. - [Privacy Policy](https://dcndx.com/privacy-policy/): Privacy policy for dcndx.com. ## Sitemap - [XML Sitemap Index](https://dcndx.com/sitemap_index.xml): Full index of crawlable and indexable pages.