DCN Dx

Name: DCN Dx
Address: 3193 Lionshead Avenue, Carlsbad, CA, US
Telephone: +17608043886

A career with DCN Dx is more than just a job: it's an opportunity to explore your passions and make real impact in today’s world.

At DCN Dx, employees collaborate with people from all over the world, develop point-of-use products with cutting-edge technologies, contribute to a market-leading business, and meet tons of smart and interesting people along the way. We’ve worked hard to create an organization that supports the success of everyone involved. We understand that “life happens”—that’s why we provide workplace flexibility to support our team members in all facets of their lives. We're passionate about being the best in the industry—and we want you to be part of it. Want to magnify your impact in the world of rapid diagnostics? There’s never been a better time: view DCN Dx's open positions at dcndx.com/careers.

09/11/2026

The next respiratory wave will not wait for your study team to finish planning.

In this episode of Expert Insights, DCN Dx’s Emily Friedland and David LaMarche of ERA Health Research explain why sponsors cannot treat respiratory enrollment as something that begins when surveillance data starts to climb.

By then, the study design should be far enough along to act, the CRO should be selected, the right site partners should be engaged, and product and workflows should be ready at the sites.

The goal is not to predict the season perfectly. It is to be prepared when the patients arrive.

Listen this weekend. Next week, take a hard look at whether your program is ready for the next respiratory window.

The full episode and free Respiratory Program Planning Timeline are linked in the comments.

09/10/2026

If you're developing a diagnostic product, or funding one, this is for you.

A team spends months developing a lateral flow assay. The bench data looks great. Then it hits the manufacturing line and the lots start failing.

Our COO Pat Vaughan has watched this play out team after team: the assay you developed often isn't the assay you can manufacture, and finding that out late can cost an early stage company a significant share of its runway.

In his new article, Pat explains why perfect benchtop data doesn't predict a strong program, and what to do about it depending on where your program stands today.

Article link in the comments.

08/31/2026

Planning an IVD submission or clinical study?

Dan Simpson, RAC, and Scott Robitaille will be at RAPS Convergence meeting with IVD developers about regulatory strategy and clinical research, including submission pathways, evidence requirements, study planning, and clinical ex*****on.

If you’ll be in Charlotte Sept. 15–17, schedule time with the DCN Dx team: https://hubs.ly/Q04vM5Y60

08/28/2026

The next respiratory wave will not wait for your study team to finish planning.

In this episode of Expert Insights, DCN Dx’s Emily Friedland and David LaMarche of ERA Health Research explain why sponsors cannot treat respiratory enrollment as something that begins when surveillance data starts to climb.

By then, the study design should be far enough along to act, the CRO should be selected, the right site partners should be engaged, and product and workflows should be ready at the sites.

The goal is not to predict the season perfectly. It is to be prepared when the patients arrive.

Listen this weekend. On Monday, take a hard look at whether your program is ready for the next respiratory window.

The full episode and free Respiratory Program Planning Timeline are linked in the comments.

08/20/2026

If you're planning EU and US market entry for a diagnostic at the same time, you're running two regulatory frameworks with different rules and the IVDR transition timelines only add pressure. The requirements diverge in ways that are cheap to plan for early and expensive to fix once you're deep into performance and clinical validation.

In this RAPS webcast, DCN Dx's Dan Simpson (Director of Regulatory Affairs) and Sarah Barchard (Senior Clinical Trials Manager) put IVDR and FDA pathways side by side. They walk through anonymized cases where a device carried a different risk class in the EU than the US, or where the performance evaluation was scoped to the wrong requirement and what it took to correct course.

If you own regulatory, quality, or clinical for an IVD headed to both markets, it's worth the hour. Link in the comments.

08/18/2026

Is a 513(g) request worth the wait?

In theory, FDA reviews them within 60 days. In practice, only 16% hit that mark, and the agency stopped tracking 513(g) timelines in its MDUFA reports as of FY 2025.

For sponsors counting on that 60-day window, the math doesn't always work.

In his article for testlab's Outlook, Dan Simpson, RAC, Director of Regulatory Affairs at DCN Dx, lays out when a binding 513(g) determination is the right call versus when a PreSub or email determination will serve you better, and why it ultimately comes down to a business decision.

Link in the comments.

08/13/2026

By the time an IVD protocol is finalized, most of the decisions that determine whether the study can be run as designed have already been made, often without input from the sites that will run it. The site feasibility questionnaire, which is supposed to capture those constraints, leaves out much of what would tell you whether a site can deliver.

Our latest Expert Insights episode is about that early stage of an IVD study. Emily Friedland, VP of Clinical Research at DCN Dx, is joined by Missy Farrell, RN, BSN, CCRC, founder and CEO of ClinicaGen Bio, a site management organization focused on non-interventional diagnostic studies, and Karen Seidler, Ph.D., founder and principal of Usable Solutions, who works in human factors and usability engineering for diagnostics and medical devices.

The conversation covers what these feasibility questionnaires miss, why the interventional pharma model is so often misapplied to non-interventional, minimal-risk studies, and where the definition of intended users and use environments belongs in the development timeline rather than at a summative usability study.

It is the first in a podcast series examining IVD clinical research from the perspective of the site. The link is in the comments.

08/10/2026

Quantitative lateral flow interpretation introduces reader variability that can affect performance characterization during development and complicate regulatory submissions later. The reader platform used during development should reflect what your intended users will have in the field.

The miniDxR is a customizable lateral flow reader designed for point-of-care settings, combining quantitative readout accuracy with a form factor practical for both development environments and clinical deployment. It's built to support the full program: assay optimization, regulatory submission data generation, and field use.

Learn more: https://hubs.ly/Q047Kx270

Address

3193 Lionshead Avenue
Carlsbad, CA

Telephone

+17608043886

Website

https://dcndx.com/careers

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