Industry-leading Genomics and Bioinformatics Center of Excellence

In the Summer of 2021, Q2 Solutions, a global leader in clinical trial laboratory services, relocated its industry-leading Genomics and Bioinformatics Center of Excellence in Durham, North Carolina. This facility is housed with other Q2 Solutions Innovation Laboratories, including the Bioanalytical Laboratory, Vaccines Center of Excellence, and the Translational Science and Innovation Laboratory (TSAIL) in a state-of-the-art, custom-designed laboratory space on the new IQVIA Innovation Park Campus. This facility joins our established genomics laboratories in Beijing, China; Edinburgh, Scotland; and Singapore to support genomics services worldwide. Collectively, these genomics laboratories received nearly 200,000 samples for complex genomic analysis from 130 different organizations in 2021. This network deploys more than forty sequencing platforms to isolate and process more than 100,000 samples annually. The new laboratory facility has doubled our core genomics laboratory square footage, and this increase in capacity extends to overall scientific equipment fleet size, biosafety cabinets, and automation. All data generated onsite are subject to Q2 Solutions’ Quality Management System, which incorporates regulatory requirements, industry standards, and best practices. As a facility whose practices comply with Good Clinical Practices for clinical and genomic testing, our new genomics laboratory maintains College of American Pathologists (CAP) accreditation and Clinical Laboratory Improvement Amendments (CLIA) and New York State (NYS) certification.

Genomic data provides a wealth of information that can inform clinical decision-making, yet the true power of large-scale genomic analysis is harnessed when these data are aggregated and integrated in the context of other types of molecular and clinical information. At the patient level, genomic data can enable earlier, targeted diagnoses, and large-scale data analysis offers disease insight at the population level. Because each patient is unique, however, maximizing an individual’s health benefits necessitates a holistic analysis. Integrating multiple data types requires collaborative, cross-disciplinary interactions. To this end, Q2 Solutions supports a range of genomic laboratory services, including DNA/RNA sequencing, bioinformatics analysis, anatomic pathology/histology and custom assay development capabilities, overlaid with Q2 Solutions expanded Bioanalytical, Immunoassay, Flow Cytometry, Vaccines, and Central Laboratory services to support biomarker studies. These services generate the molecular analyses to facilitate drug discovery, translational medicine, clinical development, and precision medicine efforts, including companion diagnostics. We leverage capabilities for next-generation sequencing (e.g., whole genome, whole exome, RNA-seq, ctDNA, T cell repertoire, single-cell RNA sequencing, and targeted sequencing), viral genome testing, Sanger sequencing, and targeted genotyping and gene expression analyses. These analyses can be applied to illuminate characteristics associated with specific disease states. For example, we offer a comprehensive immuno-oncology assay portfolio that includes immune landscape signature characterization, T-cell receptor Beta sequencing assays, and tumor mutational burden analysis that can assess the tumor microenvironment’s response to cancer.

Our Genomics and Bioinformatics Center of Excellence combines cutting edge genomics research services with state-of-the art technology platforms, bioinformatics expertise, and access to scientific thought leaders from flow cytometry, vaccine development, and large-molecule bioanalytical services. The Q2 Solutions genomics team includes assay development scientists, laboratory scientists, automation experts, pathologists, bioinformaticians, biostatisticians, quality assurance and regulatory personnel, and PMP and Six Sigma-certified project management staff. From protocol design to assay development and validation, our scientific advisors offer expertise that spans therapeutic areas and technology platforms. We partner with clients to generate and interrogate genomics data to maximize efficiency and deliver a high-quality output for every study. Although each study is unique, we remain committed to partnering based on a common set of operating principles and language, balancing individual sponsor needs with consistent account management and continuous process improvement strategies. The Genomics and Bioinformatics Center of Excellence will enable investigators to identify innovative genomic analysis solutions that can save cost, improve processes, and, ultimately, promote successful studies. This facility will support Q2 Solutions’ mission to turn patients’ hope into the help they need.