Molecular Diagnostic Solutions

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Transforming Drug Development Through Complex Molecular Tests

Pharma Solutions offers full molecular diagnostics capabilities utilizing various platforms to accommodate a variety of analyses. Its state-of-the-art molecular laboratory is technology-agnostic and equipped with the most innovative platforms, covering next-generation sequencing (NGS), genotyping, NanoString services, liquid biopsies, etc. We are a certified services provider for various companies such as Thermo Fisher, ArcherDx, NanoString, etc. and offer full NGS capabilities with both Illumina and Thermo Fisher Platforms, providing a mix of proprietary panels and off-the-shelf assays. Pharma Solutions comprehensive menu of validated assays is ready for direct use in your oncology and non-oncology programs.

Pharma Solutions is transforming global drug development with our comprehensive suite of molecular diagnostic solutions that will help identify more qualified target populations for clinical studies and optimize the safety and efficacy of therapeutic compounds. The result is an overall improvement in Return on Investment, an important consideration in the landscape of escalating drug discovery and development costs.

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Multi-Platform Approach to Genotyping

Pharma Solutions provides high quality genotyping services for clinical trials, which adhere to stringent regulatory standards including GLP, CLIA, and GCP. Our strategy is to be “platform agnostic”, meaning that Pharma Solutions is not dedicated to any one technology platform. The flexibility, scalability, and versatility, provided by a multi-platform approach, allow us to provide the best solution for a wide range of client needs. Pharma Solutions’ scientific team works with clients to choose the clinically relevant genes and variants, providing them with customizable, attention-driven service.

Over the past 15+ years, our portfolio has grown to more than 250 validated genotyping assays. If an assay for a particular gene or polymorphism is not available, our high-experience staff ensures the development and validation of new and custom assays.

To learn more about our capabilities, contact us for more information at Contact@Interpace.com   

Summary of Genotyping Services

  • Single SNP to whole-genome genotyping
  • More than 250 validated genotyping assays and growing; including Phase I and Phase II drug-metabolizing enzymes, transporters, and receptors
  • Oncology-focused NGS panels (disease-specific) spanning various hematological malignancies and solid tumors
  • Whole exome sequencing/ custom NGS panels
  • Customized pharmacogenomics (PGx) testing
  • CLIA-grade testing for FDA’s “Pharmacogenomic Biomarkers in Drug Labeling” Liquid Biopsy: profiling of circulating tumor cells, cell-free and circulating tumor DNA (CTCs, cfDNA, ctDNA)
  • Human Leukocyte Antigen (HLA) allele calling
  • Loss of heterozygosity
  • Copy number variations (CNV)
  • Microsatellite/STR analysis
  • Microsatellite Instability (MSI)
  • Comprehensive bioinformatics

Available Genotyping Platforms

Available Pharmacogenomic Genotyping Assays

As pioneers in the field of pharmacogenomics for almost two decades, Pharma Solutions helps pharmaceutical companies and clinical research organizations effectively integrate pharmacogenomics into their drug development programs to deliver safer, more effective compounds to the market more quickly.  We currently offer an extensive selection of genotyping assays for oncology, drug metabolism, CNS, and immunology/hematology.  In addition to conventional pharmacogenomics tests, we are experienced in providing custom assay development and validation. For questions or more information about pharmacogenomic testing for oncology clinical trials, please email us at Contact@Interpace.com

View Available Genotyping Assays

Unparalleled Experience in Gene Expression

At Pharma Solutions, we understand the advantages and utility of gene expression profiling in drug development. Well-designed studies can have a major impact on drug development. Our scientists have extensive experience working with clients to develop optimal study designs, sample collection protocols, and strategic application of gene expression in clinical studies.  We work with our clients to identify the molecular signature of a disease, correlate to a pharmacodynamic marker, and ensure a dose-dependent cellular response to drug exposure

Summary of Gene Expression Services Offered

  • mRNA-Seq
  • Total RNA-Seq
  • FFPE RNA-Seq
  • Fusion detection
  • Alternative splicing events
  • Toxicogenomics
  • qPCR
  • Custom expression panels

Applications of Gene Expression Profiling in Clinical Trial Patient Populations

Safety

  • Expression profiling of drug-metabolizing enzymes
  • Identify quantitative biomarkers that can be used both in early clinical trials to indicate effect and guide dose/regimen decision
  • Identify biomarkers of adverse effects prior to clinical onset of toxicity

Efficacy

  • Identify appropriate gene profiles needed to maximize therapeutic efficacy
  • Identify optimal patient population for successful clinical trials
  • Confirm stimulation/suppression of intended therapeutic target in patient populations

Development and Label Expansion

  • Whole transcriptome expression profiling combined with clinical outcomes to identify novel therapeutic targets
  • Neoantigen discovery/detection

 All of our expression analyses are available for integration into clinical studies. Custom assay development and validation services are offered to address client-specific requests. Pharma Solutions applies rigorous quality standards, including GLP and CLIA, to all studies in order to ensure the highest quality data is generated and reported. We are able to quantify gene expression in a broad spectrum of tissue samples, including formalin fixed paraffin embedded (FFPE) tissues specimens.

Pharma Solutions Offers Multiple Pre-Optimized, Validated Panels for:

Platforms

Applications

  • Oncology
  • CYP450 isozyme expression
  • Cell membrane transporters
  • Client customized gene panels

Nucleic Acid Extraction & Purification

Whether you are interested in immediate testing or storing samples for the future, Pharma Solutions offers extensive expertise with nucleic acid extraction and purification. We utilize state-of-the-art automation and skilled technicians to extract and isolate DNA and RNA from a wide variety of sample types in our CLIA-certified, GLP-compliant laboratory. With more than 25,000 extractions performed per year, our systems are easily scalable to quickly accommodate trials of any size.


Common Sample Types for Nucleic Acid Extraction

  • Whole Blood
  • FFPE Tissue
  • Bone Marrow Aspirates
  • Cell Lines
  • Buffy Coats
  • Fresh Frozen Tissue
  • Buccal Cells (DNA)
  • Saliva (DNA)
  • Hair Follicles (RNA)
  • Sample Assessment

Next Generation Sequencing

Comprehensive Profiling for Any Demand

The adoption of NGS in cancer research and clinical trials has led to a deeper understanding of tumor biology.  One of the major challenges in diagnosing hematological and solid tumor cancers is the high degree of tumor heterogeneity. Mutations that have critical clinical implications may only be present in very low levels, making detection of these mutations difficult. Detection of such mutations is especially important in hematological and solid tumor malignancies, where tumors show a great deal of heterogeneity and accurate prognosis is essential to identifying patient with more aggressive disease. NGS helps respond to these challenges by providing a comprehensive view of the tumor’s genomic profile. Importantly, NGS can detect multiple mutations present at very low levels within the tumor. 

NGS methods for genome, exome, and transcriptome analysis are leading to new genomic insights and paving the way for establishing the foundation necessary to drive the long-term goals of personalized medicine.  With the advancements in NGS technology, international projects such as the International Cancer Genome Consortium, and the economies of scale, NGS has become a powerful and clinically relevant tool.

Pharma Solutions offers an extensive suite of NGS services to meet any demand, including hypothesis-free studies, turn-key solutions with actionable content for diagnosis/prognosis/risk stratification, as well as fully customizable panels built to specification with the help of our highly trained and experienced team of bioinformaticists and scientists.

Available NGS Panels

Hypothesis Free

  • Whole Exome
  • RNA Sequencing
    • mRNA-Seq
    • Total RNA-Seq
    • Small RNA-Seq

Turn-key Solutions

  • Oncomine®
    • OncomineTM Focus
    • OncomineTM Dx Target Test
    • OncomineTM Comprehensive
  • Archer®
    • VariantPlexTM
    • FusionPlexTM
    • LiquidPlexTM
    • ImmunoverseTM
  • Illumina®
  • Hematological-focused Panels
  • Solid Tumor-focused Panels 

Fully Customizable Solutions

  • DNA or RNA
  • Built to specification
  • Integrated into clinical workflows
  • Custom bioinformatics solutions

NanoString Technologies

NanoString Technologies is a leading provider of life science tools for translational research and molecular diagnostic products. The company's nCounter® Analysis System is used in life sciences research and has been cited in more than 2,700 peer-reviewed publications. The nCounter Analysis System offers a cost-effective way to easily profile the expression of hundreds of genes, proteins, miRNAs, or copy number variations, simultaneously with high sensitivity and precision, facilitating a wide variety of basic research and translational medicine applications, including biomarker discovery and validation. The company’s GeoMx™ Digital Spatial Profiler enables highly-multiplexed spatial profiling of RNA and protein targets in a variety of sample types, including FFPE tissue sections. The company's technology is also being used in diagnostics. The Prosigna® Breast Cancer Prognostic Gene Signature Assay together with the nCounter Dx Analysis System is FDA 510(k) cleared for use as a prognostic indicator for distant recurrence of breast cancer.

We offer all NanoString® panels and have a collaborative relationship with the company to integrate custom content and panel designs for our clients, including expanded access to their technology ahead of launch through our commercial partnership