Enabling In-Vitro Diagnostics

Your IVD Partner, From Bench to Bedside

End-to-End Support for Clinical in Vitro Developers

In vitro diagnostics (IVDs) are critical tools in modern healthcare, enabling early disease detection, risk stratification, and personalized treatment decisions. The IVD development pathway is a rigorous, multi-phase process designed to ensure clinical utility, analytical validity, and patient safety.

Navigate the IVD Lifecycle with Confidence

Versiti Clinical Trial Services, the premier name in clinical study support, delivers end-to-end clinical and regulatory support for IVD developers. Our team of experts is here to streamline your path to market, from early-stage strategy through clinical validation and regulatory submission. Whether you’re developing an LDT-, RUO-, or FDA-cleared assay, we provide precision-driven support tailored to your project.

With Versiti, you can count on:

  • Unmatched diagnostics expertise
  • Integrated services
  • High-quality biospecimens
  • Fully integrated lab, clinical, and operational capabilities

Support Along the Biomarker Lifecycle

Biomarker Lifecycle

Service Capabilities

Explore Versiti’s wide range of in vitro development services and support.

 

Regulatory & Clinical Strategy

  • Regulatory pathway consultation (LDT, EUA, 510(k), PMA)
  • Clinical protocol development 
  • Clinical operations and medical writing support
  • Full program oversight and cross-functional coordination
  • IRB Review

Assay Development & Validation

  • Research-grade biomaterials 
  • Biomarker development
  • Companion Diagnostic capabilities
  • Assay development and workflow optimization
  • Analytical & clinical validations
  • Bridging studies and tech transfers
 
 

Central Lab & Operational Services

  • CAP, CLIA, and ISO-accredited lab infrastructure
  • Advanced platforms: NGS, qPCR, dPCR, flow cytometry
  • Deep expertise in hematology, transfusion medicine, and HLA typing
  • Comprehensive diagnostic test menu
  • Biostatistics, EDC, eTMF, QA/QC, and PV integration
  • Kitting, logistics, and clinical supply chain management
  • Biospecimen storage and real-time tracking

3 Common Missteps in IVD

In the complex landscape of in vitro diagnostic (IVD) development, avoiding common pitfalls is essential for accelerating timelines, reducing risk, and ensuring regulatory success. With decades of experience in diagnostics, transfusion medicine, and hematology, Versiti brings a unique, lab-integrated approach to IVD development.

 

Insufficient Clinical Validation

One of the most frequently occurring issues is advancing biomarkers without sufficient clinical validation. While early discovery may yield statistically significant signals, many biomarkers fail to demonstrate reproducible clinical utility across diverse patient populations. It’s also essential that the assay addresses a real-world clinical need; tests that lack alignment with clinical decision-making often struggle with adoption and reimbursement.

Underestimating the IVD Pathway

Another common challenge is misjudging the time, cost, and regulatory complexity of IVD development, particularly for companion diagnostics (CDx). CDx programs require a clearly defined co-development strategy or they risk falling out of sync with therapeutic timelines, delaying market entry.

 
 

Regulatory Challenges

Lastly, insufficient in-house expertise in regulatory affairs, ISO 13485 compliance, or IVDR/FDA pathways can lead to costly delays or non-compliance.

Diagnostic Powerhouse Leading the Way in IVD

Versiti’s wide breadth of experience in IVD and CDx development can help sponsors mitigate risks through early strategic planning, robust validation frameworks, and regulatory alignment. Whether you're developing a molecular diagnostic, immunoassay, or next-generation sequencing (NGS) platform, our integrated services are designed to support your success from biomarker discovery through market launch.

 
Built on Diagnostic Excellence

Trusted by clinicians and researchers nationwide.

 
Expertise in Hematology & Rare Diseases

Access to richly characterized donors and complex phenotypes.

 
Tailored, Consultative Leadship

Integrated collaboration allows us to work as an extension of your team.

 
Starting Biospecimen Access

Leukopaks, buffy coats, plasma, and whole blood from targeted populations.

 

Trusted by IVD Innovators

Versiti’s longtime partner, a global leader in molecular diagnostics specializes in rapid, automated testing solutions spanning from centralized laboratories to point-of-care testing. For over a decade and a half, they have partnered with Versiti to support the development and validation of cutting-edge diagnostic assays.

Versiti Is Here to Advance Your Assay

 
Comprehensive Clinical Trial Services and Capabilities
Explore the comprehensive suite of clinical trial services and capabilities offered by Versiti Clinical Trial Services, supporting sponsors from study design to regulatory filings and custom assay development.
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Clinical Trial Management
From protocol management to regulatory compliance, our clinical trial management services ensure seamless, end-to-end study support you can rely on.
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Explore Our Diagnostic Test Menu

Diagnostic laboratory services including HLA testing, donor testing, immunohematology reference lab testing, hematology testing and more.

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