Offering strengthens support to IVD developers across development and clinical research programs

CARLSBAD, Calif., Jan. 8, 2026 /PRNewswire/ -- DCN Dx, a specialist in diagnostics development, manufacturing, regulatory consulting, and clinical research, today announced the launch of a new prospective biospecimen collections offering, expanding the company's ability to support clients across the full lifecycle of IVD product development.

This new offering provides IRB/IEC-approved, protocol-aligned prospective collections designed to match claims, intended use, and evidence plans, helping developers generate the study data they need with greater speed, clarity, and operational control.

The new service delivers end-to-end operational ownership, including site qualification, IRB/IEC management, protocol development, comparator testing, LIMS-based data capture, kitting and logistics, and audit-ready documentation. Supported programs include analytical validation, clinical performance studies, and CLIA waiver flex studies across all major matrices, such as whole blood, saliva, tissue, nasal swabs, stool, urine, and plasma/serum. Targeted recruitment enables positivity enrichment and low prevalence cohort enrollment.

"After decades on both sides, building biorepositories and supporting diagnostic developers, I know specimen strategy can make or break a program," said Jim Boushell, Senior Vice President at DCN Dx. "It's not just sourcing samples; it's designing collections that anticipate regulatory and performance needs. Our team plans for the entire development pathway, so clients avoid downstream surprises."

The new offering reflects DCN Dx's broader strategy to meet the evolving needs of the IVD industry. As development pathways become more complex and global regulatory expectations continue to sharpen, manufacturers increasingly require partners who understand the specific operational challenges of IVD evidence generation. DCN Dx's biospecimens prospective collections integrate with their CRO and CDMO operations to keep studies, collections, and data management on the same track, or they can be contracted ad hoc.

"We built this because working with one company that understands IVD across prospective collections, assay development, and clinical studies is simply easier and more reliable for developers," said Charlie Mamrak, CEO of DCN Dx. "Whether a client engages us for their full program or just for collections, they get coordinated protocols, comparator work, and documentation that stay aligned."

For more information, visit dcndx.com/biospecimen-service/.

About DCN Dx

Based in Carlsbad, California, DCN Dx specializes in lateral flow diagnostics development, manufacturing, biospecimens, and IVD regulatory consulting and clinical research. DCN Dx's multidisciplinary CDMO specializes in creating tailored assay systems, consumables, and instruments for point-of-use applications, with a particular expertise in lateral flow assays. Their clinical research and regulatory services group specializes in the planning, execution, and oversight of IVD clinical trials, inclusive of clinical operations, data management, and biostatistics, and regulatory affairs services.

With a commitment to quality, customer satisfaction, and industry-leading expertise, DCN Dx is setting the benchmark for excellence in IVD services. To learn more about how we can support your diagnostic needs, visit dcndx.com.

MEDIA CONTACT
Mitzi Rettinger
Chief Revenue Officer, DCN Dx
Main: (760) 804-3886
Mobile: (512) 431-5836
mrettinger@dcndx.com

View original content to download multimedia:https://www.prnewswire.com/news-releases/dcn-dx-announces-launch-of-new-prospective-biospecimen-collections-service-302656556.html

SOURCE DCN Dx