Providing custom tissue based biomarker assays to help understand patient response to your therapeutic.  

With 1,200 projects completed in over 15 years of business, QualTek’s experienced scientists and project managers provide insight to your studies along with quality results delivered on time and on budget.  We have a broad background in clinical research and diagnostics, making QualTek an ideal partner for developing high quality biomarker assays and companion diagnostics.

Using immunohistochemistry (IHC) and DNA mutation analysis 
from FFPE tissue sections, our services include: 

About us
IHC Services
Mutation Analysis

QualTek is a GLP laboratory with CLIA/CAP certification.
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 

QualTek Capabilities in Support of Pharma and Biotech Clinical Research
  • IHC Assay Development - known and novel targets
  • Tissue-based Testing - human tissues, xenografts, animal model tissues
  • Companion Diagnostics Development 
  • Consulting for Companion Diagnostics and IHC Biomarkers
  • Sample Testing for Clinical Trials
  • Cell Line (cell pellet) Testing
  • Cell and Tissue Specific Expression of Targets - tumor vs normal, etc
  • Biomarker Analysis with Predictive & Pharmacodynamic (PD) Markers
  • DNA extraction from FFPE tissues
  • Assay Development for specific gene mutations 
  • FISH (Fluorescent in-situ hybridization of DNA)
  • In-situ hybridization (ISH) - detection of human Alu repeat and viral sequences
  • Apoptosis Assays to detect DNA fragmentation in cells in tissue sections
  • Digital Imaging and Analysis Capabilities
  • Tissue Bank Access: QualTek has thousands of formalin-fixed, paraffin-embedded human tissue blocks available for testing to understand target expression across disease types.  (Pathology reports are available for most tissues)
  • Routine Histology: Tissue processing, embedding and sectioning.
  • IHC Validation Services
  • Competition Experiments can be performed with peptides or recombinant protein to inhibit antibody staining
  • Interpretation of results: Many levels of analysis are available including analysis by Clinical Pathologists or Veterinary Pathologists
  • Databasing and storage services of customer research tissues is available
  • Fluorescence staining and other microscopy techniques 
  • Double-Label Studies - two different antibodies run on the same tissue section and visualized with different chromogens
  • Inter-Tumor Variation of Targets
  • IHC assay showing varied expression in different tumor types

 IHC is the microscopic visualization 
of proteins in cells and 
tissues using antibodies that bind to specific antigen targets. 
It is an ideal method for 
biomarker analysis.
Mutation Analysis
QualTek supplements its IHC portfolio with custom molecular biomarker verification and validation assays using FFPE DNA samples to establish pharmacogenetic 'signatures' necessary for evaluating treatment options or the mechanisms of human disease.
QualTek has developed hundreds of novel assays and is constantly developing new ones.  One recent assay is the IHC detection of DR5 on the cell membrane.  This assay may help identify oncology patients who will benefit from DR5/TRAIL R2 related therapies.  
New IHC Biomarkers (DR5) 
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East Coast Laboratory
300 Pheasant Run   Newtown, PA 18940
West Coast Laboratory
6483 Calle Real, Suite A   Goleta, CA 93117
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