Technology
The Drug Response Indicator Test (DRIT)
The Drug Response Indicator Test (DRIT) is a proprietary platform technology combining immunofluorescence and computerized microscopy to identify the probability of drug resistance and the measurement of drug sensitive cells in a tumor. The data correlates to the drug response of the individual patient's tumor and predicts the duration of effective drug treatment. The DRIT may be applied to fresh tumor cells, including circulating tumor cells in the blood, and archival tumor cells, including tumor cells fixed and embedded in paraffin blocks. In one test, the DRIT provides a reliable and detailed profile of a patient's tumor response rate for up to seven FDA approved, NCCN recommended anticancer drugs.
The DRIT Advantage
- Only Assay Test that simultaneously evaluates tumor response to seven FDA approved anticancer drugs
- Detailed statistical analysis of the probability of resistance & cell sensitivity to a specific drug treatment
- Determination of biomarker expression in both primary tissue sections and circulating cancer cells
- Standardization of fluorescent measurement to minimize inter-laboratory & inter-observer error
- Direct imaging of a specified target within a tissue sample
- Adaptable to different cancers, new chemotherapeutic drugs and additional biomarkers
Technology Summary
In order to establish a program of Personalized Anticancer Chemotherapy, the application of targeted anticancer therapy must be coupled with molecular diagnostic technology. The key points of CCCD's diagnostic technology are summarized below:
Specimen Source
Specimens may be derived from fresh, frozen or archival samples of primary tumors. In addition, CCCD technology allows the isolation and analysis of circulating cancer cells as representative of metastatic tumors. In this way, not only may ineffective drugs be ruled out for primary treatment, but the emergence of resistant phenotypes may be monitored.
Antibody Staining
Specimens are fixed on microscope slides and stained with appropriately labeled fluorescent monoclonal antibodies targeted toward specific cellular biomarkers. Simultaneous quantitative measurement of as many as 5 fluorescent objects may be performed as shown below:
Five images of the same field of SK-BR-3 breast cancer cells stained simultaneously with anti-estrogen receptor-AF 594, Herceptin-AF 532, anti-thymidylate synthase-AF 647, anti-cytokeratin-FITC and DAPI.
Imaging
Slides are evaluated with a unique computerized, spectral-spatial fluorescence microscopy system. The areas inside the cell containing antigen-antibody complexes can be defined, and the measurement of the fluorescence can be expressed in total fluorescence of a defined spatial region as the average fluorescence per pixel, or even the maximum intensity per pixel in this region. In addition to providing a numerically quantifiable value, the measurement can be standardized through the use of fluorescent microspheres. After the calibration, different wavelength measurements may be compared both in a temporal sense and between different instruments.
Indexing
The clinical expression of a patient's DRI is statistically analyzed using CCCD's proprietary DRI reference range index. This data is then used to compute a probability of resistance to a drug at different levels of DRI expression. This reference range can then be consulted by the attending physician for anticancer drug prescription for a given cancer patient. The predictive quality of this DRI-drug relationship will be the basis for the establishment of a system of "Personalized Anticancer Chemotherapy" (PAC).