On March 7, 2023, Robert Snyder, PhD, Associate Director of Genomics at Precision for Medicine, delivered a presentation entitled, Biobank Partnering for Clinical Trial Assay / CDx Development and High-throughput IHC & NGS Screening, at the 30th International Molecular Med Tri-Con Conference & Expo. As an end-to-end provider of biospecimens, specialty labs, and regulatory consulting services, Precision for Medicine has been supporting the development of advanced diagnostics and therapeutics for more than a decade.
In his talk, Dr. Snyder discussed how Precision for Medicine’s team of experienced lab services and biospecimen solutions providers helps to simplify and streamline the development of clinical trial assays and CDx.
Taking a Platform-Agnostic Approach
Precision for Medicine has focused on creating an infrastructure that enables researchers to develop whatever they need on platforms best suited to their goals. To that end, Precision for Medicine has adopted a platform-agnostic approach to assay development that allows the scientific objective and intended application of the assay to guide platform selection. In addition, our specialty lab and biomarker assay services team has expertise across all sample types, from nucleic acids and proteins to cells and tissues.
For immunohistochemistry (IHC)-based assays, researchers can select among the top staining platforms—Roche/Ventana, Dako, and Leica—and can access a full range of biomarker analysis services, from assay and scoring system development to custom kitting, sample processing, and centralized pathology reading. To highlight Precision for Medicine’s experience in IHC-based assays, Snyder reviewed a case study involving the design, development, and validation of a custom p-cadherin IHC assay and scoring system to be used for patient selection in a global Phase 1 oncology study.
Figure 1. Precision for Medicine comprehensive IHC biomarker analysis services
For high-throughput next-generation sequencing (NGS)–based assays, researchers have access to the Illumina NovaSeq and NextSeq platforms and the ThermoFisher Genexus system, and Precision for Medicine can onboard other systems as needed. Beyond IHC and NGS, Precision for Medicine also offers proprietary technologies such as Epiontis ID® for epigenetic immunophenotyping and ApoStream® for isolation of circulating tumor cells (CTCs) and other rare cells.
Using an Existing Biobank to Advance CDx Development
Precision for Medicine has over 3 million formalin-fixed, paraffin-embedded (FFPE) samples and several million histology slides covering a full spectrum of oncologic and other diseases. In late 2020, Precision for Medicine launched an ambitious program to prospectively sequence many of the stored tissue blocks to identify those with mutations of particular interest for targeted drug development. Through a single partnership, more than 10,000 FFPE samples were characterized across 11 oncology indications using a targeted 50-gene panel that screens for single nucleotide variants (SNVs), indels, fusions, and amplifications. As part of an even larger initiative, 800 FFPE samples are being sequenced per month using a broad, 500+ gene panel for tumor mutational burden (TMB), microsatellite instability (MSI), SNVs, indels, copy number variations (CNVs), fusions, and splice variants for verification, validation, and generation of orthogonal data for regulatory submissions.
For researchers, having access to specimens accompanied by an easily searchable database of NGS-characterization and associated variants available for purchase simplifies assay development.
Moreover, partnering with a third-party lab services provider for external validation helps accelerate the development and regulatory submission process.
Accelerating the Path From Bench to Bedside
Deeply annotated samples are critical for clinical trial assay and CDx development. The strategic approach to assay development differs depending on how the assay will be applied, whether it is to obtain CLIA validation, support a clinical trial, or submit for companion diagnostic approval. However, regardless of application, the development process can be made easier with access to pre-characterized samples, pathology expertise, NGS services, and regulatory support.
Figure 2. Precision for Medicine accelerates assay commercialization from bench to bedside
Precision for Medicine works with a global network of partner hospitals across more than 55 countries for prospective patient sample collections, all under IRB-approved protocols with end-to-end chain of custody. We also offer central and specialty lab services, regulatory guidance, and an integrated data platform called QuartzBio®, which enables virtual sample inventory management for real-time tracking of samples across sites, labs, and repositories. With our expertise in assay development, validation, regulatory submissions, and commercialization, Precision for Medicine can help developers map out the best path from bench to bedside.
To learn more about how Precision for Medicine accelerates clinical trial assay and CDx development, contact us.
To learn more about Precision for Medicine’s biospecimens, visit www.PrecisionBiospecimens.com
About the Author
Dr. Snyder is a chemical and biomedical engineer with 20 years of genomics experience. His career in this space began at the Institute for Genomic Research shortly after the completion of the Human Genome Project. His path to Associate Director at Precision for Medicine included working in NGS oncology assay development with a focus on regulatory submission study design for verification and validation.