Anatomic Pathology Laboratory Services

Q2 Solutions’ comprehensive in-house end-to-end anatomic pathology lab, adjunct molecular and histology services are designed to meet your clinical trial needs 

The future healthcare market landscape is quickly changing, and it is necessary to have an anatomic pathology lab partner who can deliver the services you need. Having a comprehensive anatomic pathology strategy can be crucial to ensuring clinical and commercial success of your product.

Support for your anatomic pathology needs

With access to commercial clinical laboratories and a full in-house global Anatomic Pathology (AP) service with a foot print in the Americas, Europe, Asia-Pac and China, and a lab operations team who are adept at assay transfer and validation, we have the ability to support your unique study needs. We create tailored solutions for every trial, based on tissue and tumor type, staining requirements, and the need for customized assays.  Download our anatomic pathology services brochure to learn more about our AP capabilities. 

Companion Diagnostic experience – Our scientific experts provide you with an optimal path to co-develop your companion diagnostic with clinical development of the therapeutic, regulatory submission and market launch.  Our integrated approach is designed so you optimize time to market and commercial success.  

Learn more about our companion diagnostic capabilities. 

Innovation– Our innovative digital pathology solutions promote faster, more collaborative analysis through the use of innovative, leading edge products and services to enable communication of richer efficacy signals faster and more cost-effectively. Learn more about our digital pathology offering.

Globally harmonized Anatomic Pathology in-house services

We offer a quality management system that delivers high quality, dependable data for your study. All clinical laboratories across our regions ensure a globally harmonized SOP process that minimizes technical variability in your study. All of our expert pathologists, histotechnologists, clinical, and laboratory staff are trained in good documentation practices, with each AP lab containing on-site experts with >20 years’ experience.

We capture turnaround time in each of our labs, with a goal of at least 98% achievement of turnaround time (TAT) for each study. Our Anatomic Pathology laboratories also participate in an accuracy-driven external quality assurance program (CAP Proficiency Testing) that supports our goal of achieving global harmonization, standardization and high quality results across the globe for every study.

Anatomic Pathology for Biomarker Development in Oncology Clinical Trials  – Q2 Solutions can provide customized, global laboratory anatomic pathology lab solutions specifically suited for the unique combinations of therapeutic indication and targeted mechanism-of-action driving modern oncology drug development.

Industry Trends Our Testing Solutions
Less Invasive Sampling
  • Liquid biopsy: cell free nucleic acids and circulating tumor cells (CTCs)
  • Mutation detection including Next Generation Sequencing
  • Flow cytometry, immunoassays, proteomics
Shift toward molecular methods
  • Next generation sequencing (NGS) replacing FISH panels
  • Gene expression panels replacing multiple IHCs
Ultra-high sensitivity
  • Mutation detection at < 0.01%
  • Single-cell analysis by flow cytometry/molecular platforms
  • Detection of disease and early resistance
Companion Diagnostics
  • Already established for many methods
  • Expanding to genomics/NGS platforms

Experience predicting and assessing a patient’s response to checkpoint inhibitors is an integral function to immuno-oncology drug development. Once a tissue sample is received, central AP testing is performed, and data can be mined for immuno-oncology characterizations, such as PD-L1 proteins or tumor-infiltrating lymphocytes.  We then take those characterizations and apply them to drug studies, such as the creation of predictive biomarkers for patient selection.

Anatomic Pathology lab partner for your success

Q2 Solutions has the breadth and depth of scientific experience and expertise across all major therapeutic areas, which help drug developers effectively gain a competitive advantage – helping ensure your success in clinical trials, regulatory approvals and new product launches.

We’re able to go a step further with our capability to validate, transfer, and employ new assays to meet today’s development opportunities. These abilities add significant value as we develop new assays for your trials. Learn more about our global Anatomic Pathology lab services.

Q2SM Oncology Infographic

Providing one global lab partner to support your oncology research from discovery to post-market

Adapting Clinical Trial Best Practices to a Complex Global CDx Landscape

World CDx Europe 2019

Tumor Mutational Burden (TMB) Assay for Response to Immunotherapy

TMB assay utilizing whole exome sequencing (WES) methodology and proprietary variant analysis compendium

Q2 Solutions Biomarker Services

Providing tools and experience to maximize your biomarker strategy

Q2SM Global Anatomic Pathology Solutions

Learn how we can advance your clinical trials

Genomic Based Solutions for Your Immuno-oncology Drug Development Needs

Genomics-based biomarker approach

Clinical Trials Laboratories in the Immuno-Oncology Setting

Increased demands lead to increased opportunities

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