The DirectHit Test Panel Breast Cancer is designed to quantitatively measure biomarker expression levels in formalin fixed, paraffin embedded tumor tissue. Biomarker quantitation in approximately 500 tumor cells is based on fluorescent dye-labeled monoclonal antibody staining, followed by analysis of digital images using fluorescence 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 are 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 tumor will be non-responsive to treatment.
CCC Diagnostics, Inc. has been certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA ID # 21D1043279). In addition, the lab is licensed in the state of Maryland (MD. State Permit # 1274). Licensing covers the testing of specific biomarkers as applied to the prediction of clinical outcomes in breast cancer patients treated with NCCN recommended therapies.