Translational Medicine Services
Mosaic Laboratories supports numerous translational medicine programs, and our biomarker data is presented to the FDA as evidence of drug activity and for patient pre-screening. Our professional staff includes licensed pathologists, licensed medical technologists, and experienced technicians. Management has played a role in companion diagnostic optimization, validation and clinical trial testing.
Mosaic Laboratories has an extensive collection of formalin-fixed, paraffin embedded human cancer and normal tissues for evaluation and validation of tests such as immunohistochemistry, FISH and molecular assays.
Proper optimization and validation of assays is a critical step to any biomarker program. Proper validation includes an assessment of assay sensitivity, specificity and precision. Additional criteria such as accuracy, LOQ determination, LOD determination, linearity, interferences, normal range evaluation, robustness and other parameters apply for quantitative tests or as appropriate. A sample validation report is available upon request.