QualTek Molecular Laboratories
 Call Us: 215-504-7402
HomeOur VisionAbout QualTekIHC ServicesApplied IHCNewsCareers

Clinical Trials
QualTek has maintained involvement in patient sample-testing for hundreds of clinical studies on behalf of our biotechnology and pharmaceutical partners. These studies range from small (n = 25-100 patients) to large (n = >1,000 patients) utilizing single or multiple biomarkers.

Archival and/or fresh tissue samples may be sent directly to QualTek from participating sites. Prospective and retrospective testing is available.

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

  • Reproducibility & precision testing
  • Large scale sensitivity testing in target tissue types (available from our extensive Tissue Bank)
  • Specificity analysis in cell lines, xenografts, animal tissues, & normal human tissues
  • Scoring scheme development
  • Expression rate analysis for cut-off determination 
QualTek offers prospective handling, testing, and analysis of patient samples with fast turnaround times (3-6 days).

  • Inferfacing with clinical sites and central laboratories
  • Sample log & database management
  • Processing & embedding of received samples
  • IHC testing of clinical samples  
  • Customized reporting & data transfer
  • Adherence to GLP and CLIA guidelines
Phase I - III Clinical Studies