DCN Dx

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

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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.

10/30/2026

What could happen when a region loses access to a laboratory-developed test for which no commercial alternative exists?

“Fatal? It could be fatal.”

Jesse Young, Ph.D., of TriCore Reference Laboratories points to hantavirus testing in the Four Corners region as an example of why some LDTs exist. They address specific community needs that may not be met by a widely available commercial test.

Regulation matters. So does preserving a path for qualified laboratories to develop and validate tests for unmet needs.

In this clip from Expert Insights, Jesse and host Emily Friedland discuss the consequences for patients when that balance is lost. The full episode also features Dan Simpson, RAC, on what the 2025 court decision changed and what IVD developers still need to consider.

Watch the clip, then listen to the full conversation. Links in the comments.

10/29/2026

A cancer diagnosis alone doesn’t tell a researcher whether a specimen fits a study. Disease stage, treatment history, and patient demographics matter.

DCN Dx has acquired BioSouthTech to broaden access to the patient populations drug and diagnostic researchers need to reach. Based in the Miami area, BioSouthTech brings a Latin American collection network and access to specimens from the Caribbean, expanding our sample bank and patient reach.

For teams developing liquid biopsy assays, including multicancer early detection and measurable residual disease tests, specimens must reflect the disease stages and patient populations under study.

“You can’t develop a test for everyone on data from a few,” says Jim Boushell, our senior vice president of biospecimens.

Starting now, DCN Dx customers can request characterized tissue and matched sets off the shelf or stand-up prospective collections designed to their own protocol across oncology, neurology, and infectious disease. The network already reaches patients across a range of ancestries and regions, and new geographies and expanded cohorts are planned for early 2027.

Read the acquisition announcement in the first comment.

10/28/2026

An assay can perform well in the hands of the team that developed it. A clinical lab still has to decide whether it can validate the test and support it over time.

In this clip, Jesse Young, Ph.D., puts the stakes plainly: the lab may use that result to change a patient’s life. Manufacturers need to arrive with performance data and a process another operator can reproduce.

Jesse joins Dan Simpson, RAC, and host Emily Friedland in the newest episode of Expert Insights. They discuss what the 2025 federal court decision changed for laboratory-developed tests, what it left unsettled, and what IVD developers still need to get right.

Watch the clip, then listen to the full episode at the link below or on your favorite podcast platform:

https://hubs.ly/Q04xWb2m0

10/22/2026

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.

10/20/2026

Planning a clinical study for an infectious disease diagnostic?

Your diagnostic’s intended use, target population, and evidence needs shape the study. Meet DCN Dx at IDWeek to discuss study feasibility, site selection, and the questions your team is working through.

Our clinical research services support IVD developers through study design, trial management, data management, biostatistics, and regulatory affairs.

Stop by booth 1042, October 21–24, in Washington, D.C.

10/19/2026

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/Q047KPRF0

10/14/2026

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.

10/13/2026

Meet with DCN Dx at booth 1042 to explore how our IVD CDMO, CRO, lyophilization, and biospecimen services can support your project.

From assay development and device engineering to clinical research and regulatory affairs, our team brings expertise across the diagnostic development process. Whether you’re refining an assay, tackling a design challenge, or planning a clinical study, we’d love to hear what you’re working on and discuss how we can support.

Request a meeting with our team in advance: https://hubs.ly/Q04zQlSZ0

10/12/2026

Some assays cannot remain frozen in time when the target they detect is changing.

Jesse Young, Ph.D., of TriCore Reference Laboratories uses hantavirus as an example. Viral variation may require a laboratory to update primers or other parts of its method while continuing to serve the same clinical need.

That creates a difficult regulatory question: How should oversight account for a test that must evolve with the organism it detects, especially when the test serves a specific regional population?

In this clip from Expert Insights, Jesse explains why laboratory-developed testing remains ongoing work for scientific and regulatory communities.

Watch the clip, then listen to Jesse’s full conversation with Dan Simpson, RAC, and Emily Friedland. Links in the comments.

10/08/2026

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.

Address

3193 Lionshead Avenue
Carlsbad, CA

Telephone

+17608043886

Website

https://dcndx.com/careers

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