DirectHit

DirectHit is a pharmacodiagnostic test used to determine the tumor sensitivity or resistance to drug regimens recommended for the treatment of breast cancer by the National Comprehensive Cancer Network. It is a noninvasive test performed on small amounts of tissue removed during the original surgery lumpectomy, mastectomy, or core biopsy. DirectHit was developed by CCC Diagnostics Inc., a biotechnology company established by former researchers from Johns Hopkins University. DirectHit was launched on 14 January 2010. Currently, it is the only available test for predicting treatment outcomes for anticancer chemotherapy drugs for breast cancer.

DirectHit is based on quantitative immunofluorescence technology. According to recent studies, quantitative immunofluorescence (QIF) can be applied to the standardization of protein analysis, resulting in increased sensitivity and reproducibility. It is important to be able to quantitate the expression of predictive factors in breast cancer, because response to therapy is often dependent upon the concentration of particular proteins within the tissue.

DirectHit utilizes monoclonal antibodies (mAb) corresponding to each biomarker to stain the tumor tissue samples. Slides are evaluated with a computerized, fluorescence microscopy system . Digital images are acquired through a CCCD camera. An algorithm was developed to process and analyze the digital images allowing direct relation between the amount of a specific protein within the cancer cells of the tumor and response to the corresponding drug. Quantitative measurement of up to five signals in a single cell can be obtained.

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