Molecular Diagnostics and Infectious Disease Testing

Advancing Precision Medicine Through Partnership and Innovation

Improving Patient Outcomes with Versiti

Versiti Clinical Trial Services provides cutting-edge molecular diagnostics and infectious disease testing services by collaborating closely with researchers and clinicians to deliver high-quality solutions that support everything from basic research to clinical trials.

Molecular Diagnostics Services

Customized Research Support

The Versiti team works closely with you to align with your study goals, ensuring expertise you can count on at every step, from workflow design to SOP development and quality control.

Supported Applications

Explore our broad portfolio of molecular testing capabilities:

Next Generation Sequencing (NGS) Infographic
Quantitative/Digital Polymerase Chain Infographic
Flow Cytometry Infographic
Protein & Cell-Based Assays Infographic
Liquid Chromatography Mass Spectrometry Infographic

Next-Generation Sequencing (NGS)

  • T-cell receptor (TCR) sequencing
  • Somatic mutation analysis
  • RNA-Seq and miRNA-Seq

Digital PCR

  • Rare mutation detection
  • Quantified molecular standards
  • Capillary/Sanger Sequencing
  • Sequence confirmation
  • Fragment analysis

Quantitative PCR (qPCR)

  • Germline and somatic genotyping
  • Copy-number variation
  • mRNA, miRNA, and lncRNA expression analysis

Infectious Disease Assay Development

  • Custom assay design and validation
  • Companion Diagnostic (CDx) development

Immunoassays

  • ELISA
  • Immunogenicity testing

Flow Cytometry

  • Immunophenotyping
  • Cell-cycle analysis
  • NK cell quantification
  • Gene activity profiling

Additional Information & Support

Sample Types

  • FFPE, FNA, LCM
  • Whole blood, plasma, serum, PBMCs
  • Stool, urine, nasal/pharyngeal, buccal swabs

Bioinformatics

  • Intra- and inter-sample gene activity analysis
  • TCR repertoire profiling

Expanding Our Capabilities to Support Your Goal

Don’t see what you’re looking for? Our unique breadth of partners and in-house assay development experience allow us the flexibility to grow our capability list with your needs in mind.

Let’s Talk About Your Project
 

High-Throughput Processing and Regulatory Compliance

Versiti supports projects of any scale, from preclinical studies to large-scale trials. Our GLP-compliant labs are equipped with validated instrumentation and staffed by experts in molecular biology, genomics, and regulatory science.

Bioproduction Quality Control (QC)

Versiti understands the importance of establishing quality-control systems and reagents in the development of biological assays and agents for use in research and medicine. Our industry-leading expertise in these systems and well-established familiarity with the pharmaceutical and biotechnology industries allow us to offer such robust QC services as:

  • Residual DNA testing
  • Synthetic assay standards
  • Known-positive biological controls
  • In-process checkpoint standards
 
 

Infectious Disease Testing Services

Infectious disease testing in clinical trials focuses on evaluating new treatments, vaccines, diagnostics, or preventive strategies for diseases caused by pathogens like bacteria, viruses, fungi, or parasites. Versiti is proud to offer such cutting-edge services as:

Diagnostic Services

  • Pathogen detection (PCR, culture, antigen/antibody)
  • Viral load quantification
  • Serology (IgG/IgM)
  • Molecular diagnostics (RT-PCR, NGS)

Analytical & Laboratory Services

  • Biomarker analysis (cytokines, inflammatory markers, HLA)
  • Hematology and clinical chemistry
  • Flow cytometry for immune profiling
  • Custom Assay Development
  • Companion Diagnostics

Case Highlight: Advancing Global Health and Diagnostic Innovation

Versiti is proud to have promoted the global DeWorm3 initiative by supporting a five-year surveillance study aimed at interrupting the transmission of soil-transmitted helminths (STH) in India, Benin, and Malawi.

  • Our team developed and validated a high-throughput, multiplex qPCR assay, and DNA isolation protocol for four STH species
  • This allowed for the analysis of over 200,000 stool samples
  • From these samples, global partners can monitor the effectiveness of Mass Drug Administration (MDA) and move toward a more sensitive, molecular-based diagnostic standard

Key Collaborators: Bill and Melinda Gates Foundation, University of Washington, PATH, Smith College, Thermo Fisher Scientific, Argonaut Manufacturing Services.

What Other Trial Support and Management Services Does Versiti Offer?

 
Study Design & Site Selection Services
Optimize your Clinical Trial Study Design with expert site selection and monitoring services tailored to ensure trial success from start to finish.
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Data & Project Management
At Versiti Clinical Trial Services, we provide dedicated project and data management teams to support your clinical trials from start to finish.
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Collection Kits, Biologistics & Clinical Supplies
Versiti offers specimen collection kit design, clinical supplies, and full biologistics support—streamlining trials from site to shipment.
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Quality & Regulatory Services
Versiti’s Quality and Regulatory services equip therapeutic developers with the expertise to navigate complex regulations and ensure compliance.
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Blood Product Infectious Disease Screening

 

Versiti offers a comprehensive menu of infectious disease screening tests, including:

  • CMV Antibody
  • Hepatitis B Surface Antigen
  • Hepatitis C Core and Virus Antibodies
  • HIV Antibody
  • Human T-Lymphotropic Virus (HTLV)
  • Trypanosoma Cruzi Antibody (Chagas)
  • West Nile Virus (WNV)

Contact Versiti to Jump Start Your Research

Let’s accelerate your research and improve patient outcomes.

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