QualTek excels at handling all project requirements for IHC testing and analysis of patient samples for clinical trials.

Maintains morphology of cells and tissues

Benefits of IHC Testing

QualTek IHC Services

Detects protein, not RNA

Provides cell specific resolution

Allows for cell type identification

Enables visualization of subcellular localization

Can detect post-translational modifications

Allows for storage and archiving of study materials

Preliminary Research:

• Selection of the best commercially available primary antibodies for particular targets of interest.
  

• Selection of appropriate controls and test tissues from the QualTek Tissue Bank.
  

Optimization of IHC Assay:

• Testing and selection of optimal pre-treatment conditions
  

• Titration of primary antibody concentration
  

• Testing and selection of optimal detection system
  

Interpretation and Analysis:

• Image capture and image analysis
  

• QualTek electronic report describing final assay conditions and tissue reactivity with representative digital images
  

See Examples

Pre-clinical studies:

• Cell line and formalin-fixed, paraffin-embedded (FFPE) cell pellet testing
  

• Analysis of xenografts and animal tissues
  

• Pre-testing of target in select human tissue types
  

Phase I through Phase III clinical studies:

• Sample and database management
  

• Processing and embedding of received samples
  

• Histology sectioning and H&E staining
  

• IHC testing of clinical samples
  

• Adherence to GLP guidelines
  

Interpretation and Analysis:

• Analysis can include review by a certified pathologist
  

• IHC staining scores may include:
  

Relative expression: low, moderate, high

Percentage of positive cells

Intensity of staining

H-scores (weighting intensity &

% positive cells)

Data resolution

Quantitation and/or estimation

• Image capture and image analysis
  

• QualTek electronic report describing tissue reactivity with representative digital images
  

See Examples

East Coast Laboratory

300 Pheasant Run   Newtown, PA 18940

West Coast Laboratory

6483 Calle Real, Suite A   Goleta, CA 93117

Novel target immunohistochemical stain of a formalin-fixed, paraffin-embedded breast carcinoma.

QualTek staff are experts in development of IHC assays for biomarkers that may be integrated into clinical studies. We use all of the resources at our disposal to develop the best IHC assay possible for any target protein.

• QualTek can perform diagnostic IHC assays that determine expression levels of particular proteins or specific mutations; information which helps tailor drug therapy for individual patients based on their molecular profile.
  

• QualTek can also assist companies in Companion Diagnostic development based on our diagnostic background and experience in clinical studies.
  

See Examples

TUNEL (Apoptosis Assay) in breast carcinoma

Nuclear staining in breast cancer cell line

FISH