In precision medicine, cancer immunotherapy continues to provide new ways to treat patients using the body’s own immune system, and immuno-oncology (I-O) drug development utilizes a combination of scientific and operational expertise. There are many different approaches to I-O development, and we provide novel and innovative immunotherapy laboratory services that combine scientific expertise, innovative technologies, and industry relationships.

End-to-end service

We have a broad spectrum of technologies to address biomarker requirements, from early engagement through clinical trial testing and commercialization of assays. Our scientists can work with Translational and Biomarker scientists to develop a biomarker strategy early in clinical development and help deliver the strategy by engaging our team that has proven expertise in executing and delivering science data for I-O clinical development programs.

Service offerings include:

• Full suite of laboratory testing services available globally – Safety testing, Small and Large Molecule BioAnalytical, Anatomical Pathology with IHC & FISH, Genomics, Flow Cytometry and Immunoassay. Applications for these tests include safety, efficacy, proof of mechanism, pharmacodynamic and patient selection.
• Data analytics – Utilize data from our parent organizations for data mining to provide information relevant to identifying clinical trial sites, hotspots for a particular biomarker positive population, and specifications on biomarkers and associated treatment history that can assist in inclusion/exclusion into an I-O clinical trial.
• Bioinformatics – Services are provided at the US and China sites for next generation sequencing-based (NGS-based) large data set solutions providing insights into interpretable outputs. Data can be extracted from high throughput RNA or DNA sequencing technologies for specific applications in determining tumors.
• Commercialization - The transition from a clinical trial assay to a commercial assay is key for market adoption of those assays that become standard of care or Companion Diagnostics (CDx). A parent organization participates in early validation programs and can receive training and gain proficiency through our pathologists.

Global Footprint

We are a premier global central laboratory service provider for I-O clinical development testing. We have a global central laboratory network including a footprint in the Americas, Europe, Asia-Pacific, and China and a breadth of technological expertise and harmonized processes are available across our laboratories.

Broad Capabilities in Flow Cytometry, Immunoassay, Anatomic Pathology and Genomics:

• Flow Cytometry services – as an integral part of your comprehensive Immuno-oncology biomarker strategy, we provide flow cytometry services in preclinical and clinical studies, including in early clinical development when assessing mechanism of action (MOA) for therapeutic antibodies.
• Immunoassay services – a range of protein measurement services from basic ELISA to more automated immunoassays can be used for measurement of acute proteins and safety issues, from single-analyte to multiplex immunoassay technologies.
• Anatomic Pathology services – Commercial and clinical laboratories, full in-house global anatomic pathology services, digital pathology solutions, and global capacities provide comprehensive in-house end-to-end anatomic pathology and molecular methods, including PD-L1. We provide complex biomarker analysis to achieve higher-quality, more precise data to advance your I-O studies.
• Genomics services – our Q² Solutions l EA Genomics Center of Excellence provides services that span clinical development from discovery to commercial testing. We offer a comprehensive portfolio of genomic assays for immuno-oncology applications, with a continuing expansion of genomics solutions.

Integrated science team of experts – Q² Solutions broad range of scientists and subject matter experts across the company include the following fields:

• Immunologists
• Geneticists
• Technical experts
• Pathologists
• Clinical scientists
• Bioinformaticists
• Regulatory

Certain immuno-oncology programs also have an associated biomarker-based Companion Diagnostics (CDx) program, and Q² Solutions can provide full support to develop your CDx.