QualTek Molecular Laboratories
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.
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