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.

Expert Insights podcast episode: DCN Dx CEO Charlie Mamrak on building an IVD services company. This is a nuts-and-bolts...
06/19/2026

Expert Insights podcast episode: DCN Dx CEO Charlie Mamrak on building an IVD services company. This is a nuts-and-bolts conversation about how DCN decides what services to build, what to keep narrow, and what to avoid, including:

-How customer demand shapes the roadmap (and what doesn’t make the cut)
-Why DCN has invested in biospecimens prospective collections
-Where integration helps and where “more capabilities” can create more friction
-How Charlie thinks about build vs. buy vs. collaborate as the company scales

Listen here or where ever you get your podcasts: https://hubs.ly/Q042w2B-0

If you're developing a diagnostic product, or funding one, this is for you.A team spends months developing a lateral flo...
06/18/2026

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.

DCN Dx provides prospective biospecimen collections with the documentation and traceability IVD programs need for valida...
06/17/2026

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/Q0433x_G0

When you align regulatory strategy early, you reduce rework later, especially around intended use, claims, and the evide...
06/16/2026

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/Q044vwl20

After the European Commission proposed its IVDR revision in December, many companies decided to wait and see what makes ...
06/16/2026

After the European Commission proposed its IVDR revision in December, many companies decided to wait and see what makes it into the final text before they file. The 2026 transition deadlines did not wait with them. The dates for higher-risk classes have already passed, notified bodies report that submissions have dropped enough that some may close, and the Commission has been clear that no more extensions are coming.

In this episode of the Expert Insights podcast, Dan Simpson, RAC, Director of Regulatory Affairs, and Sarah Barchard, Clinical Trials Manager, talk through what that holding pattern costs a company selling into both the EU and the US, and why planning for both markets at the same time is the way to protect against the uncertainty.

Dan covers the regulatory side: where the EU and US frameworks diverge. Sarah covers the clinical trials side: where the requirements pull in different directions once you reach analytical and clinical validation.

It's the lead-in to their free RAPS webcast on June 17 at 12pm ET, where they go through the case studies behind these questions.

👉 Listen to the podcast episode and register for the RAPS webcast - links in the comments.

Part 2 of our CLIA waiver strategy series is live.In Part 1, Dan Simpson and Emily Friedland covered the intended use de...
06/15/2026

Part 2 of our CLIA waiver strategy series is live.

In Part 1, Dan Simpson and Emily Friedland covered the intended use decision: the POC/OTC distinction, the three pathways to waived status, dual versus step-wise submissions, and why waiver does not carry over from a predicate or an EUA.

Part 2 picks up at the study design stage and gets into where CLIA waiver comparison studies for molecular diagnostics go wrong:

-Operator recruitment that does not reflect the intended use population.
-Site selection that fails to capture environmental variability.
-Pre-analytical variables, specimen collection in particular, that closed-cartridge design does not eliminate.
-Invalid rates that raise questions about simplicity thresholds.
-The study design decisions required to support both a 510(k) and a waiver application in a dual submission.

The piece also addresses the OTC path for molecular IVDs, where the human factors burden is higher than POC and the regulatory precedent is still developing.

If you are designing a near-patient molecular test program and CLIA waiver is on the roadmap, these are the study design considerations that belong in your pre-submission, not mid-enrollment.

Links to both Part 2 and Part in the comments.

If regulatory bandwidth is your bottleneck, DCN Dx can help. Our regulatory affairs team supports IVD programs with path...
06/10/2026

If regulatory bandwidth is your bottleneck, DCN Dx can help.

Our regulatory affairs team supports IVD programs with pathway assessment, FDA Pre-Subs, STeP requests, submission support (510(k), de novo, PMA), and EU IVDR technical documentation and notified body coordination.

Learn more: https://hubs.ly/Q0433kYT0

Picking a CRO for an IVD clinical study is mostly risk management. The problems often show up late: sites that don’t enr...
06/09/2026

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/Q040YxjZ0

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