DCN Dx Introduces Innovative Biospecimen Collections Service to Enhance IVD Development
DCN Dx, based in Carlsbad, California, specializes in diagnostics development, regulatory consulting, and clinical research. The company has recently announced the launch of an innovative prospective biospecimen collections service aimed at supporting in-vitro diagnostics (IVD) developers throughout the entire product lifecycle. This new initiative is set to enhance the capabilities of diagnostics developers by ensuring that they have access to IRB/IEC-approved, protocol-aligned specimen collections that are designed to match regulatory claims and evidence needs.
The importance of a robust specimen collection strategy cannot be overstated in the realm of diagnostic development. According to Jim Boushell, Senior Vice President at DCN Dx, "specimen strategy can make or break a program." This insight stems from decades of experience in both building biorepositories and supporting diagnostic developers. Understanding the unique regulatory and performance requirements necessary for success allows DCN Dx to offer a service that not only sources samples but also anticipates the specific needs of clients at every stage of development.
The new service features comprehensive operational ownership, including crucial elements such as site qualification, IRB/IEC management, and detailed protocol development. Moreover, it incorporates logistics services, data capture through LIMS (Laboratory Information Management System), and audit-ready documentation. Supported programs encompass a variety of research phases, including analytical validation, clinical performance studies, and CLIA waiver flex studies across diverse sample types like whole blood, saliva, tissue, nasal swabs, stool, urine, and plasma/serum.
Targeted recruitment strategies will allow for positivity enrichment and the enrollment of low prevalence cohorts, thereby enhancing the reliability and applicability of study results. This significant development demonstrates DCN Dx’s strategic response to the evolving needs of the IVD landscape, where complex development pathways and stringent global regulatory expectations are becoming the norm.
As manufacturers increasingly seek partners that comprehend the operational challenges inherent in IVD evidence generation, DCN Dx's new biospecimen collections service stands out. Integration with their Contract Research Organization (CRO) and Contract Development and Manufacturing Organization (CDMO) operations ensures that studies, collections, and data management remain streamlined and compatible. Clients have the flexibility to engage DCN Dx for either their entire program or on an ad-hoc basis, allowing for a tailored approach that fits their specific needs.
Charlie Mamrak, CEO of DCN Dx, articulated the company’s commitment: "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." The coordination of protocols, comparator work, and aligned documentation means that clients can expect a smoother and more efficient developmental journey.
With a focus on quality, customer satisfaction, and expertise, DCN Dx aims to set a new standard of excellence in the IVD service sector. For more information about their new biospecimen service and how it can benefit diagnostic developers, visit dcndx.com/biospecimen-service/.
The importance of a robust specimen collection strategy cannot be overstated in the realm of diagnostic development. According to Jim Boushell, Senior Vice President at DCN Dx, "specimen strategy can make or break a program." This insight stems from decades of experience in both building biorepositories and supporting diagnostic developers. Understanding the unique regulatory and performance requirements necessary for success allows DCN Dx to offer a service that not only sources samples but also anticipates the specific needs of clients at every stage of development.
The new service features comprehensive operational ownership, including crucial elements such as site qualification, IRB/IEC management, and detailed protocol development. Moreover, it incorporates logistics services, data capture through LIMS (Laboratory Information Management System), and audit-ready documentation. Supported programs encompass a variety of research phases, including analytical validation, clinical performance studies, and CLIA waiver flex studies across diverse sample types like whole blood, saliva, tissue, nasal swabs, stool, urine, and plasma/serum.
Targeted recruitment strategies will allow for positivity enrichment and the enrollment of low prevalence cohorts, thereby enhancing the reliability and applicability of study results. This significant development demonstrates DCN Dx’s strategic response to the evolving needs of the IVD landscape, where complex development pathways and stringent global regulatory expectations are becoming the norm.
As manufacturers increasingly seek partners that comprehend the operational challenges inherent in IVD evidence generation, DCN Dx's new biospecimen collections service stands out. Integration with their Contract Research Organization (CRO) and Contract Development and Manufacturing Organization (CDMO) operations ensures that studies, collections, and data management remain streamlined and compatible. Clients have the flexibility to engage DCN Dx for either their entire program or on an ad-hoc basis, allowing for a tailored approach that fits their specific needs.
Charlie Mamrak, CEO of DCN Dx, articulated the company’s commitment: "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." The coordination of protocols, comparator work, and aligned documentation means that clients can expect a smoother and more efficient developmental journey.
With a focus on quality, customer satisfaction, and expertise, DCN Dx aims to set a new standard of excellence in the IVD service sector. For more information about their new biospecimen service and how it can benefit diagnostic developers, visit dcndx.com/biospecimen-service/.
Topics Health）
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