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QualTek Molecular Laboratories

Goleta, California, US

QualTek is an industry leader in the field of immunohistochemistry (IHC) and its vast applications. Our mission is to provide the highest quality IHC biomarker and tissue-based assay services to support and accelerate research and clinical studies with pharmaceutical and biotechnology partners. QualTek’s capabilities cover a broad spectrum of research and clinical studies in various therapeutic areas including oncology, inflammatory, metabolic, neurologic, and cardiovascular diseases and disorders. Our experience and understanding of applied IHC allows us to integrate IHC data into various stages of the dynamic drug development process from basic research to testing of Phase I-III clinical samples to development of Companion Diagnostics.

The founders of QualTek previously established BioTek Solutions in 1989; a company that designed instrumentation and detection systems to automate assays for immunohistochemistry... Show more »

QualTek is an industry leader in the field of immunohistochemistry (IHC) and its vast applications. Our mission is to provide the highest quality IHC biomarker and tissue-based assay services to support and accelerate research and clinical studies with pharmaceutical and biotechnology partners. QualTek’s capabilities cover a broad spectrum of research and clinical studies in various therapeutic areas including oncology, inflammatory, metabolic, neurologic, and cardiovascular diseases and disorders. Our experience and understanding of applied IHC allows us to integrate IHC data into various stages of the dynamic drug development process from basic research to testing of Phase I-III clinical samples to development of Companion Diagnostics.

The founders of QualTek previously established BioTek Solutions in 1989; a company that designed instrumentation and detection systems to automate assays for immunohistochemistry (IHC) and in-situ hybridization (ISH). These instruments were sold worldwide, primarily to clinical pathology laboratories. BioTek Solutions merged with Ventana Medical Systems resulting in a successful IPO in 1996. Out of this experience, QualTek Molecular Laboratories was founded in 1997 to fill a need for expertise in IHC assays and analyses in the research and clinical communities within biotechnology and pharmaceutical companies.

Publications

  • Immunohistochemistry assays in Good Laboratory Practice Studies, F. Lynch, S. Bernstein and H, Battifora
  • Validation of Cell-Based Assays in the GLP Setting: A Practical Guide, Editors: Uma Prabhakar & Marian Kelley, Wiley, 2008. ISBN: 978-0-470-02876-6
  • Molecular Pathology: Immunohistochemistry assays in drug development performed by a contract research laboratory, F. Lynch and S. Bernstein
  • Molecular Pathology in Drug Discovery and Development, Editor: J. Suso Platero, Wiley, 2009 ISBN: 978-0-470-14559-3
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QualTek Molecular Laboratories has not listed any services.

Immunohistochemistry (IHC)
Price on request

QualTek uses IHC as a platform to better understand the expression and potential role of target biomarkers in various disease and experimental tissues. IHC provides an understanding of how, where, and to what extent a target is expressed within and among normal and disease tissues. IHC provides a great deal of information that... Show more »

QualTek uses IHC as a platform to better understand the expression and potential role of target biomarkers in various disease and experimental tissues. IHC provides an understanding of how, where, and to what extent a target is expressed within and among normal and disease tissues. IHC provides a great deal of information that allows scientists and clinicians to make cutting-edge decisions about the direction of clinical development and which patient populations to treat.

QualTek will develop and test your research target by offering extensive assay development, validation, screening, and scoring scheme development.

This includes:

  • Reproducibility & precision testing
  • Large scale sensitivity testing to determine penetrance of expression in various disease tissue types from QualTek’s extensive Tissue Bank and experimental tissues
  • Specificity analysis in cell lines, xenografts, animal tissues, & normal human tissues
  • Scoring scheme development
  • Expression rate analysis for cut-off determination
  • Evaluation of Pharmacodynamic & Predictive Markers
  • Development of prototype Companion Diagnostic assays
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Companion Diagnostic Development
Price on request

QualTek offers a logical and cost-effective option to companion diagnostic development. QualTek will first develop a quality assay and determine if the therapeutic and IHC test are effective - eliminating the mistake of prematurely investing in a commercial assay. QualTek then provides prospective testing of patient samples to... Show more »

QualTek offers a logical and cost-effective option to companion diagnostic development. QualTek will first develop a quality assay and determine if the therapeutic and IHC test are effective - eliminating the mistake of prematurely investing in a commercial assay. QualTek then provides prospective testing of patient samples to generate pivotal information in conjunction with development of the most relevant companion diagnostic test.

Our philosophy for developing Companion Diagnostics is to serve as an advocate for our partners in all aspects of the process from assay development through commercial support. QualTek is not associated with a specific platform and we are unencumbered with no agenda other than supporting the success of our partners. We provide honest consultation throughout the process empowering our sponsors to make cutting-edge decisions for their therapeutic program.

Key services include:

  • Prototype test development (e.g. PD-L1 assay for lung carcinoma clinical study)
  • Platform independent approach
  • Expert consultation for:
    • Optimal antibody selection
    • Appropriate scoring scheme
    • Pivotal cut-off decisions
    • Strategy for testing & commercialization
  • Prospective testing of clinical samples (CLIA)
  • Accumulation of pivotal data
  • Validation reports for inclusion in regulatory filings
  • Logical & cost-effective approach
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Image Analysis
Price on request
  • Data resolution
  • Quantitative analysis using various software algorithms
  • Whole slide scanning (Aperio)
  • Data resolution
  • Quantitative analysis using various software algorithms
  • Whole slide scanning (Aperio)
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Histology and Pathology Services
Price on request

QualTek’s team of certified pathologists provide expert tissue evaluation and IHC analysis. Analytical evaluation of target expression includes:

  • Relative expression: low, moderate, high
  • Percentage of positive cells
  • Intensity of staining
  • Identification and designation of staining patterns
  • Consideration of... Show more »

QualTek’s team of certified pathologists provide expert tissue evaluation and IHC analysis. Analytical evaluation of target expression includes:

  • Relative expression: low, moderate, high
  • Percentage of positive cells
  • Intensity of staining
  • Identification and designation of staining patterns
  • Consideration of heterogeneity
  • Use of widely accepted methods (e.g. H-score, Allred, Quick, etc.)
  • Novel development of customized scoring scheme
  • Expression rate analysis for cut-off determination
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Human Tissue Procurement
Price on request

QualTek maintains an extensive Tissue Bank that can be used for various research and clinical applications. Our bank includes tens of thousands of formalin-fixed, paraffin-embedded (FFPE) human tissues covering a vast range of normal, cancer, inflammatory, and other disease tissues. Most samples have associated pathology reports. ... Show more »

QualTek maintains an extensive Tissue Bank that can be used for various research and clinical applications. Our bank includes tens of thousands of formalin-fixed, paraffin-embedded (FFPE) human tissues covering a vast range of normal, cancer, inflammatory, and other disease tissues. Most samples have associated pathology reports.

Tissue Bank Features

  • Surgical & autopsy cases
  • Broad array of diseases
  • Normal tissues
  • Multi-tissue blocks

QualTek's Histology Services

  • Tissue accessioning & sample log updating
  • Tissue processing & embedding
  • Paraffin sectioning of tissues
  • Specimen decalcification
  • Hematoxylin & Eosin (H&E) staining & interpretation
  • Special Stains including:

AFB (Ziehl-Neelsen method) for acid fast bacilli, Alcian Blue for sulfated mucosubstances, Brown-Brenn Gram Stain for gram + and gram – bacteria, Congo Red for amyloid, Giemsa for H. pylori and Bone Marrow, GMS (Grocott's Methanamine Silver) for fungus, Gomori's Modified Iron Stain, Masson's Trichrome for muscle and collagen, Modified Snook's for reticular fibers, Mucicarmine for mucin, Muller-Mowery Colloidal Iron for acid mucosubstances, PAS (Periodic Acid Schiff's) for glycogen and fungus, Verhoeff's-Van Gieson for elastic fibers and many more...

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Assay Development
Price on request

QualTek's vast experience with thousands of antibodies allows us to quickly develop high-quality IHC assays that may be used in research and clinical studies in any and all disease types. We develop assays with a fit-for-purpose approach. These assays may be developed using a combination of cell lines, submitted experimental... Show more »

QualTek's vast experience with thousands of antibodies allows us to quickly develop high-quality IHC assays that may be used in research and clinical studies in any and all disease types. We develop assays with a fit-for-purpose approach. These assays may be developed using a combination of cell lines, submitted experimental or clinical tissues, and samples from QualTek’s extensive Tissue Bank.

Preliminary Research

  • Determination of the best commercially-available primary antibodies for targets of interest
  • Selection of appropriate control and test tissues from our Tissue Bank

Optimization of IHC Assay

  • Testing & selection of optimal pre-treatment conditions
  • Titration of primary antibody concentration
  • Testing & selection of optimal detection system

QualTek ensures that the target IHC assay is ready for your clinical study by offering extensive assay validation, tissue screening, and scoring scheme development.

This includes:

  • Reproducibility & precision testing
  • Large scale sensitivity testing in any tissue type
  • Specificity analysis in cell lines, xenografts, animal tissues, & normal human tissues
  • Scoring scheme development
  • Expression rate analysis for cut-off determination
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Project Management
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Clinical Research
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Clinical Laboratory Services
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Clinical and Anatomic Pathology
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Biology
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Cells and Tissues
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Biospecimens
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Human Biospecimen Collection
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Biochemistry & Molecular Biology
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Protein Services
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Protein Expression Visualization
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Immunostaining
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Computational Modeling
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Data Services
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Medical Devices & Diagnostics
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