Data presented at the annual meeting of the American Society of Clinical Oncology further validated ChromaVision Medical Systems automated cellular imaging system (ACIS). The data from a collaborative study conducted by the United States National Institutes of Health, the Institute of Pathology in Basel, Switzerland, and two diagnostic companies, DAKO A/S and Vysis, Inc, documented that results of the ACIS HER2 immunohistochemical test correlate strongly with overall patient survival. Tests that provide information to help predict both the time and likelihood of survival are vital to clinicians in guiding critical treatment decisions.
Additional Tests Unnecessary
ChromaVision vice president and chief science officer Kenneth D. Bauer, PhD, said, Perhaps the most striking observation is the finding that ACIS scoring allowed for the identification of prognostically distinct patient populations, which could not be identified by alternative analytic methods evaluated in this study.
Additional data obtained in studies of more than 1,500 patients indicate that ChromaVisions tissue microarray analysis technology has considerable potential for accurate quantitative scoring of HER2 expression, compared with the current subjective manual method, Dr. Bauer added. ACIS is the only automated system capable of objectively analyzing HER2 samples using fractional scoring, potentially eliminating the need for additional tests to be performed on a patient, he said.
Significant Prognostic Marker
Results of the study presented at ASCO showed that there was an excellent correlation (greater than 92%) among the 530 cases analyzed using ACIS with results obtained using fluorescent in situ hybridization, an alternative technique that is considerably more technically demanding, costly, and time consuming than immunohistochemical methods. Significantly, the study also showed a strong association between HER2 expression in the tumor and patient survival (P < .0001), confirming the importance of the accuracy of HER2 analysis as a prognostic marker.