DCN Dx

Planning to market your at-home test for wellness? Before you commit to that launch plan, understand how FDA’s general wellness policy may apply to your product. DCN Dx’s Wellness Regulatory Assessment is led by Dan Simpson, RAC, our Director of Regulatory Affairs. Dan reviews your product’s intended use, claims, collection or sensing method, and how results are presented to users. You receive a written assessment explaining how the policy may apply, the likely regulatory implications, and whether and how to contact FDA. The fixed fee is $6,900, with delivery in two to four weeks from kickoff and receipt of the materials needed for review. The assessment is DCN Dx’s professional opinion, not an FDA determination, clearance, or approval. Start with a 30-minute call to discuss your product and whether the assessment fits your needs. Learn more and request a call: dcndx.com/wellness #Diagnostics #RegulatoryAffairs

What a week. ALFC 2025 brought together an incredible mix of thinkers and operators who are building what’s next in rapid diagnostics. Thank you to every speaker, poster presenter, judge, sponsor, and attendee who showed up with real insight and made the conversations useful. A big thank you to our sponsors for powering the experience and community. Your support helps us keep this event practical, welcoming, and focused on progress. To our production crew, volunteers, and venue teams, we appreciate you. You made everything look effortless. Hit play on the recap to catch a few highlights. If you joined us this year, tell us your biggest takeaway in the comments. #ALFC2025 #lateralflow #rapiddiagnostics #IVD #medtech #healthtech #pointofcare

In this new episode of Expert Insights, BioDot’s Rob Rich joins Mitzi Rettinger to talk about what “designing for manufacturability” really means. They dig into the early decisions that prevent scrap and rework, how to stage the move from benchtop to pilot, and the small SOP choices that make or break yield. If you work in lateral flow development or manufacturing, you’ll want to hear this one. 🎧 Listen to the episode [link in the comments] 🎟️ Register for ALFC 2025—live in La Jolla or virtually—with code ALFC25 for 25% off at https://hubs.ly/Q03MLgcT0! Presented in partnership with BioDot, Gold Sponsor of ALFC 2025. #ExpertInsights #LateralFlow #LFA #RapidDiagnostics #IVD #PointOfCare #Manufacturing #DiagnosticsManufacturing #ALFC2025

The countdown to ALFC 2025 is on! Mitzi Rettinger, Chief Revenue Officer at DCN Dx and Chair of the ALFC Organizing Committee, breaks down what to expect at this year’s Advanced Lateral Flow Conference—two days of cutting-edge science, candid discussions, our sold-out exhibitor floor, and unmatched networking in La Jolla, California. From AI's role in rapid diagnostics to the new realities of funding and regulation, here’s what makes ALFC 2025 the global meeting point for rapid diagnostics. 📖 Article link in the comments. #ALFC2025 #Diagnostics #RapidTesting #LateralFlow #IVD #HealthCare

The ALFC 2025 exhibit floor is officially sold out! Strong demand from across rapid diagnostics filled every booth, but there are still ways to reach this highly targeted audience. A limited number of promotional opportunities remain for companies ready to showcase their products and services to 300+ diagnostics decision-makers in La Jolla and virtually. This year’s theme—Catalyzing Growth: Tech Advancements, Funding, and Regulatory Roadmaps in LFA—captures the momentum driving the industry forward. Link to the press release in the comments. #ALFC2025 #LateralFlow #RapidDiagnostics #RapidTesting #IVD #PointOfCare #HealthTech #MedTech #Diagnostics

Surface chemistry on gold nanoparticles is one of the quiet levers that decides how your lateral flow test performs in the real world. In this episode of Expert Insights, host Mitzi Rettinger and DCN Dx COO Patrick Vaughan, Ph.D., talk with Kimialys’ Claude Noguès, Ph.D. (CSO) and Cyril Gilbert (CEO) about K-One, their patented approach to controlling ligand orientation and minimizing non-specific interactions on gold. Presented in partnership with Kimialys, Gold Sponsor of ALFC 2025. Podcast listeners can enjoy 25% ALFC in-person and virtual registrations by using code ALFC25 at checkout. Links in the comments. #LateralFlow #IVD #Diagnostics #PointOfCare #Biosensors #AssayDevelopment #ALFC2025