DCN Dx Tackles IVD Hurdles with Integrated Biospecimen Service

CARLSBAD, CA – January 08, 2026 – Diagnostics specialist DCN Dx today announced a significant expansion of its services with the launch of a prospective biospecimen collections offering, a move designed to provide a seamless, end-to-end solution for in vitro diagnostic (IVD) developers. The new service aims to address a critical bottleneck in the industry by integrating ethically sourced, protocol-aligned human samples directly with the company's established contract development, manufacturing, and clinical research operations.

This strategic expansion positions the company to offer a unified pathway for IVD manufacturers, potentially accelerating product development timelines and de-risking the complex journey from concept to market. By taking ownership of the entire evidence-generation process—from specimen collection to final data analysis—DCN Dx seeks to eliminate the logistical and regulatory hurdles that frequently arise when developers are forced to manage multiple, disconnected service vendors.

The Integrated Advantage in a Fragmented Market

The development of a new diagnostic test is a multifaceted process that traditionally requires coordinating with numerous specialized partners: one for assay development, another for manufacturing, a separate biorepository for sourcing patient samples, and a contract research organization (CRO) to run clinical trials. This fragmented approach often leads to communication gaps, timeline delays, and data inconsistencies that can jeopardize a regulatory submission.

DCN Dx's new offering is engineered to solve this very problem. By providing a single point of contact for services spanning the full IVD lifecycle, the company offers a more cohesive and reliable alternative. The service includes end-to-end operational management, covering everything from clinical site qualification and Institutional Review Board (IRB) or Independent Ethics Committee (IEC) oversight to protocol development, comparator testing, and the delivery of audit-ready documentation. This integration is designed to ensure that every stage of a project remains aligned.

"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, in the company's announcement. "Whether a client engages us for their full program or just for collections, they get coordinated protocols, comparator work, and documentation that stay aligned."

This holistic model allows for greater operational control and clarity. For IVD manufacturers, this can translate into significant efficiencies, reducing the administrative burden and allowing their internal teams to focus on core scientific innovation rather than vendor management.

Beyond the Sample: The Science of Specimen Strategy

The new service underscores a crucial industry reality: successful diagnostic development is about more than just obtaining samples. It requires a sophisticated biospecimen strategy that is meticulously planned from the outset. The quality, characterization, and relevance of the specimens used for validation can directly determine the success or failure of a diagnostic product.

"After decades on both sides, building biorepositories and supporting diagnostic developers, I know specimen strategy can make or break a program," noted 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."

This philosophy is embedded in the new offering, which focuses on designing prospective collections tailored to a product's specific claims and intended use. The service supports a wide range of programs, including analytical validation, clinical performance studies, and CLIA waiver flex studies. It can manage collections across all major biological matrices, such as whole blood, saliva, tissue, nasal swabs, stool, and plasma/serum. Furthermore, its targeted recruitment capabilities enable positivity enrichment and the enrollment of low-prevalence cohorts, a common challenge that can significantly slow down clinical studies for diagnostics targeting rare conditions.

By ensuring that specimen collection protocols are perfectly aligned with downstream analytical and clinical needs, this approach helps generate robust, high-quality data that can withstand intense regulatory scrutiny and provide a solid foundation for a product's performance claims.

Navigating a Stricter Regulatory Gauntlet

DCN Dx's strategic expansion comes at a time of increasing regulatory pressure on the IVD industry. Global frameworks, most notably the European Union's stringent In Vitro Diagnostic Regulation (IVDR), have raised the bar for clinical evidence, demanding more comprehensive data on a product's safety and performance. These regulations place a heavy emphasis on the quality, traceability, and ethical sourcing of the biospecimens used in validation studies.

Meeting these heightened requirements necessitates meticulous documentation and an unwavering commitment to quality management. DCN Dx's focus on providing "IRB/IEC-approved" collections and "audit-ready documentation" directly addresses these market pressures. By managing the ethical oversight and ensuring a clear chain of custody, the service helps clients mitigate regulatory risk and build a compliance-ready submission package from day one. This proactive approach is critical for navigating the complex and often divergent requirements of global health authorities like the FDA and European bodies.

Failure to provide adequate evidence tied to properly sourced and documented biospecimens can lead to costly delays or outright rejection, making an integrated and compliant biospecimen strategy more valuable than ever.

Meeting the Demands of a Growing IVD Industry

The global IVD market is on a steady growth trajectory, with some projections estimating its value will exceed $135 billion by 2035. This expansion is fueled by an aging global population, the rising prevalence of chronic and infectious diseases, and the rapid advancement of personalized medicine. As the demand for more accurate and accessible diagnostic tools grows, so does the need for high-quality biospecimens to support their development and validation. The specialized biospecimen procurement market is likewise expanding, with analysts forecasting a compound annual growth rate of over 8% in the coming decade.

DCN Dx's launch of its prospective collections service is a direct response to these powerful market forces. The move leverages the company's deep-seated expertise in diagnostics, particularly in lateral flow assays, and builds upon its existing CRO and contract development and manufacturing organization (CDMO) capabilities. By creating a fully integrated service portfolio, DCN Dx is positioning itself as a comprehensive partner for IVD developers navigating an increasingly competitive and regulated landscape. This strategic adaptation reflects a broader industry trend toward outsourcing to specialized partners who can provide the deep expertise and integrated infrastructure needed to bring innovative diagnostics to patients faster.