DCN Dx

DCN Dx 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 flexibil

ity 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.

Most lateral flow assay problems that show up at production volume were already present at the bench. They just weren't ...
05/29/2026

Most lateral flow assay problems that show up at production volume were already present at the bench. They just weren't visible yet.

In the latest Expert Insights episode, DCN Dx's Mitzi Rettinger talks with Daniel Levenson, Business Development Manager at KinBio, about what the R&D-to-manufacturing transition actually requires: automation beyond dispensing and strip cutting, in-line vision inspection, CTQs, multiplex complexity, and how to build processes that hold up under real throughput pressure.

If your team is planning a scale-up — or starting to scope what it will take — this conversation covers the specifics.

Listen: https://hubs.ly/Q047p09S0

Is a 513(g) request worth the wait?In theory, FDA reviews them within 60 days. In practice, only 16% hit that mark, and ...
05/28/2026

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.

Quantitative lateral flow interpretation introduces reader variability that can affect performance characterization duri...
05/25/2026

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/Q047KVQ_0

Picking a CRO for an IVD clinical study is mostly risk management. The problems often show up late: sites that don’t enr...
05/21/2026

Picking a CRO for an IVD clinical study is mostly risk management. The problems often show up late: sites that don’t enroll, messy data, protocol changes midstream, and a claims package that needs rebuilding.

We developed a Clinical Performance Study CRO Evaluation Rubric to help IVD teams compare clinical research partners using weighted criteria and a consistent scoring scale.

If you’re vetting CROs right now, this might save your team some back-and-forth.

Download the rubric: https://hubs.ly/Q040Yxvp0

New from Dan Simpson, RAC (Director of Regulatory Affairs, DCN Dx): a practical breakdown of FDA Predetermined Change Co...
05/19/2026

New from Dan Simpson, RAC (Director of Regulatory Affairs, DCN Dx): a practical breakdown of FDA Predetermined Change Control Plans (PCCPs), with an emphasis on what needs to be in the package for AI-enabled IVD submissions.

Prefer audio? We also covered the topic on a recent Expert Insights podcast episode with Dan and Emily Friedland, VP of Clinical Research, DCN Dx.

Links to both in the comments.

Listen to Dan Simpson, RAC, Director of Regulatory Affairs at DCN Dx, and Emily Friedland, VP of Clinical Research at DC...
05/14/2026

Listen to Dan Simpson, RAC, Director of Regulatory Affairs at DCN Dx, and Emily Friedland, VP of Clinical Research at DCN Dx, break down what FDA expects in a PCCP, how PCCPs show up in 510(k)/De Novo/PMA submissions, and what teams need to have in place to execute the plan post-market.

Listen on our website or where ever you get your podcasts: https://hubs.ly/Q0405MBc0

Read the companion article: https://hubs.ly/Q0405K1r0

DCN Dx provides prospective biospecimen collections with the documentation and traceability IVD programs need for valida...
05/13/2026

DCN Dx provides prospective biospecimen collections with the documentation and traceability IVD programs need for validation and clinical evidence.

We deliver IRB/IEC-approved, protocol-aligned collections with:

👉Full traceability and chain of custody
👉Targeted recruitment for low-prevalence cohorts and positivity enrichment
👉Support across key study needs: analytical validation, clinical performance, CLIA waiver flex, reproducibility, bridging, and lot release
👉End-to-end ex*****on: site qualification, protocol development, comparator testing, LIMS-based data capture, logistics, and audit-ready documentation

Learn more: https://hubs.ly/Q0433wQq0

When you align regulatory strategy early, you reduce rework later, especially around intended use, claims, and the evide...
05/12/2026

When you align regulatory strategy early, you reduce rework later, especially around intended use, claims, and the evidence plan.

Here’s what one client shared about working with our Regulatory Affairs team.

If you’re planning an FDA pre-sub, evaluating a 510(k) vs de novo strategy, or building an EU IVDR plan (including performance evaluation and technical documentation), DCN Dx can help you define the most defensible path forward.

Learn more here: https://hubs.ly/Q044vsLf0

"We'll source specimens later" is one of the most reliable ways to add months to an IVD program.In the latest episode of...
05/11/2026

"We'll source specimens later" is one of the most reliable ways to add months to an IVD program.

In the latest episode of Expert Insights, Jim Boushell, SVP of Biospecimens at DCN Dx, breaks down why specimen strategy belongs in the development strategy conversation, not downstream as a procurement task.

Jim draws on his decades of biorepository and IVD development support work to cover:

-How to align a specimen plan to an evidence plan from the start
-Prospective vs. banked specimens and when each makes sense
-What a high-integrity data package includes
-How DCN Dx's IRB/IEC-approved prospective collections service is designed for IVD evidence generation

If you're in development and specimen planning isn't on the table yet, this episode is worth a listen.

Listen on Spotify, Apple Podcasts, or the DCN Dx website: https://hubs.ly/Q04cf1y_0

Siloed clinical systems can't keep pace with IVD research. Study startups stall. Data fragments across tools. Timelines ...
05/11/2026

Siloed clinical systems can't keep pace with IVD research. Study startups stall. Data fragments across tools. Timelines slip.

At Veeva MedTech Summit 2026, DCN Dx's Thomas Martinache (Associate Director, Data Management) and Jill Hutton-Pugh (Clinical Trial Manager) will walk through how a CRO can run high-intensity IVD trials on a connected platform—using Veeva EDC, eTMF, and CTMS together rather than as separate systems.

Join us in Chicago to see what operational transformation looks like when clinical data, documents, and trial management share one source of truth.

📍 Chicago, IL
📅 Tuesday, May 12, from 12:30–1:15 p.m. CT
🎟️ DCN Dx: Delivering Intense Study Management via a Connected Platform

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