Clinical Validation
Retrospective Correlation Studies
Retrospective correlation studies were conducted in order to validate The DirectHit™ Test Panel for Breast Cancer as a pharmacodiagnostic laboratory service to predict the treatment outcomes of hormonal therapy and chemotherapy. Clinical Partners were the University of Maryland Marlene and Stewart Greenebaum Cancer Center, HarborView Cancer Center, Walter Reed Army Hospital and Zhangzhou Hospital. The drugs and their respective biomarkers are: 5-FU, capecitabine/thymidylate synthase, docetaxel, paclitaxel, abraxane /beta-tubulin isoform III, trastuzumab/Her-2, antiestrogens/estrogen receptor. CCC Diagnostics is currently expanding this study to include anthracyclines, gemcitabine, and platinum salts.
Results from this study indicate:
- DirectHit analysis of ER displays higher accuracy (91%) than immunochemistry (67%).
- DirectHit analysis of HER-2 displays higher accuracy (94%) than immunochemistry (44%)
- DirectHit displays exceptional predictive accuracy for chemotherapy response (87%).
- DirectHit displays a high degree of diagnostic performance.
- DirectHit accurately identifies both effective and ineffective treatments.
This study indicates that the DirectHit Test Panel for Breast Cancer can provide accurate prediction of treatment outcomes. DirectHit analysis can improve the response rate to chemotherapeutic drug treatment by accurately identifying effective and ineffective drugs for individual late stage breast cancer patients.
The results from this study have been presented at the San Antonio Breast Cancer Symposium, December 2008 and the American Society for Clinical Oncology (ASCO) annual meeting, June 2009, in Orlando, FL.