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Discovery’s Global Tissue Biomarker Services: A New Offering to Advance Precision Oncology Programs With Biospecimen Solutions, Biomarker Testing and Pathologist Training Services

Small Scientist on June 15, 2021

Tech Snapshot® captures today’s cutting-edge tools and technologies that will help drive drug discovery tomorrow. This installment was written by Discovery Life Sciences, the Biospecimen and Biomarker Specialists™.

Discovery’s Global Tissue Biomarker Services are a novel and unique combination of biospecimen solutions, multi-omic biomarker testing and pathologist training services launched to help advance precision oncology programs. Scientists leading these programs need to make informed strategic decisions to successfully navigate complex targeted oncology, diagnostic, immuno-oncology and cell therapy studies. Discovery’s Global Tissue Biomarker Services accelerate this challenging process by helping clients identify and understand biomarkers within their target populations at every stage of research and clinical development. Discovery’s biospecimens and molecular pathology-guided, multi-omic biomarker services - including IHC, multiplex in situ, tumor cell sorting, flow cytometry and NGS services - allow clients to use a single strategic partner to build study cohorts, develop and validate biomarker assays, conduct clinical trial studies and train pathologists in the field for quicker adoption of new companion diagnostic assays.

At every stage, Discovery delivers robust multi-omic datasets that can help contribute to clients’ understanding of target expression and drug response within their intended study populations. From there, Discovery’s experts perform biomarker testing in global clinical trials for both retrospective and prospective studies. When new assays receive regulatory clearance, we can help speed adoption into clinical routine by training a network of pathologists around the world how to apply companion and complementary diagnostic assays in practice. Discovery’s premium biospecimen solutions, expert multi-omic biomarker services and experienced pathologist training services offer clients an unprecedented, global, tissue biomarker toolbox that helps guide oncology biomarker programs, outpace the competition and push the leading edge of precision medicine.

Biospecimens
Our biorepository is 10 million+ biospecimens strong while our global clinical site network, Discovery Partners®, consists of 300+ clinical sites with access to millions of patients worldwide to support prospective studies. Sample types available cover standalone and matched sets spanning FFPE, plasma, PBMCs, fresh frozen, biofluids, dissociated tumor cells (DTCs), blood and others. This unmatched access to diverse, well characterized biospecimens allows scientists to build stronger, bespoke study cohorts with the characteristics relevant to their research.

To aid in advanced biospecimen selections, our expert biomarker testing service labs streamline multi-omic biomarker identification to determine if target biomarkers are present. We routinely screen hundreds of specimens for genomic and immunological markers. An example case study with 200 lung cancer specimens demonstrates the utility of these provisions.

Figure 1: Lung Cancer Biomarker Screening
200 lung cancer tissue specimens annotated by select genomic and immunological markers via our integrated, multi-omic biomarker testing service labs in the US and Europe.

HudsonAlpha Discovery, Discovery’s sequencing and bioinformatic lab, provides additional value once biospecimens are selected via our optimized dual RNA / DNA extraction services from FFPE. Our FFPE RNA extraction services yield quality RNA with DV200 scores >20% and 98% downstream sequencing success rates.

Table 1: Optimization of RNA isolation from FFPE tissues increases the probability of successful RNA-seq studies

Molecular Pathology Services
Discovery’s molecular pathology experts help clients identify and understand biomarkers within their target populations at every stage of research and clinical development - from assay development and validation to clinical trial support and pathologist training for market adoption. To support these efforts, Discovery’s multi-omic biomarker service labs leverage a wide array of immunohistochemical and genomic technology platforms, including Illumina, 10X, PacBio, Leica, Roche / Ventana, Zeiss, Aperio, Dako / Agilent, Akoya, Ultivue, NanoString, Visiopharm, Techmate, BioTechne / ACD and others.

Table 2: Tissue Biomarker Capabilities

Assay Development and Validation
Our experts start with the end in mind to tailor assays for the right targets in the right patients on the right platforms. We employ an industry-leading assay validation approach that starts with careful assay development and optimization but doesn’t stop there. We do more than simply demonstrate that an assay can detect a target in various conditions, we:
— Conduct large scale sensitivity screening of cancer patient populations to understand expression patterns within and among tumor indications
— Demonstrate precision and reproducibility using serial sections from samples with various levels of known target expression (from sensitivity screen)
— Analyze specificity in cell lines, xenografts and normal human tissues
— Develop a robust scoring scheme to properly and consistently capture levels of target expression
— Analyze expression rate for cut-off determination in various disease indications

Figure 2: Precision and reproducibility testing is formatted such that samples from each expression level (high, moderate, low and negative) are tested in 3 different runs (only high shown here), by at least 2 different operators, in triplicate. In each run, an isotype control (e.g., Rb IgG, Ms IgG1, Ms IgG2a depending on primary antibody) is also tested as the negative control (bottom row).

Leading biopharmaceutical companies trust our assay development and validation approaches to design robust assays with wide dynamic range and high precision and reproducibility. Our experts built the prototype companion diagnostic assay that laid the foundation for the successful 22C3 PD-L1 companion diagnostic assay widely utilized today to select patients eligible for treatment with the anti-PD-1 immunotherapy pembrolizumab. We have also been instrumental in the successful companion diagnostic development of HER2, BRAF, MSI and other PD-L1 assays.

Clinical Trial Services
Once assays are cleared, we can support global clinical trials at any scale on Leica, Roche / Ventana, Dako / Agilent and other technology platforms. Our global teams have conducted biomarker testing in more than 1,200 international clinical trials, on more than 300,000 study patient samples, and are involved in more than 300 active trials. Our clients trust us to deliver high quality results at speed and scale to accelerate global clinical trials using a single chain of custody that adheres to appropriate regulations and quality standards.

Pathologist Biomarker Training Services
We help accelerate post-market adoption with expert training for pathologists and technicians. We’ve trained more than 4,000 pathologists worldwide.

About Discovery
Discovery Life Sciences is the Biospecimen and Biomarker Specialists™. We combine the world’s largest commercial biospecimen inventory and procurement network with preeminent multi-omic biomarker service laboratories to accelerate precision medicine programs for cancer, infectious disease and other complex conditions. Learn more by visiting our website www.dls.com or contact us at info@dls.com.