DirectHit™ Technology
Currently, limited options are available for selecting an optimal treatment regimen for a particular patient at a given stage of disease. CCCD offers a diagnostic service, the DirectHit™ Test Panel , for predicting treatment outcomes prior to the selection of anticancer drug therapy for individual patients. The tests in the panel are designed to quantitatively measure biomarker expression levels in formalin fixed, paraffin embedded tumor tissue. Biomarker quantitation in > 500 tumor cells is based on fluorescent dye-labeled monoclonal antibody staining, followed by analysis of digital images using computer-assisted microscopy calibrated to an external standard. Standardization to an external reference allows a high degree of inter-observer, inter-instrumentation reproducibility. Biomarkers chosen for each drug as an indicator of tumor response is related to the mechanism of drug action.
Biomarker expression measurement results in classification of the tumor as sensitive or resistant to a particular drug. A tumor classified as sensitive to a drug by DirectHit predicts that the patient will respond to treatment, while a tumor that is classified as resistant predicts the patient will be non responsive.