• Discuss study goals and timelines with sponsor
• Understand mechanism of action and targeted biomarkers of interest
• Determine appropriate controls, i.e. cell lines, xenografts, animal and human control tissues
• Determine tumor indications of interest – if unclear, survey many indications

• Select biospecimens with specific characteristics, e.g. metastatic, morphologic distinction, etc.
• Determine the best commercially available primary antibodies for targets of interest
• Identify novel antibodies and screen clones from internal antibody campaigns

• Test & select optimal pretreatment conditions
• Determine assay specificity
• Test range and linearity for assay robustness
• Screen tissue and test sensitivity

• Develop scoring scheme
• Validate precision & reproducibility
• Adhere to applicable GCLP guidelines
• Deliver IND submission-ready analytical reports

• Conduct IHC testing of research or clinical samples – retrospective or prospective studies
• Determine assay specificity
• Provide full-service histology and ASCP certified pathology analysis
• Determine expression across tumor indications (Tumor Survey)

• Set cut-off for positivity for patient sample screening and enrollment (CAP/CLIA)
• Develop Prototype CDx: strategy for testing & downstream commercialization
• Deliver customized reporting & data transfer
• Adhere to GCLP and CLIA guidelines

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