HistoRx, a leading developer of tissue-based theranostic solutions to advance individualized patient care, today announced that the Company’s proprietary AQUA? technology, an automated image analysis platform based on tissue-based quantitative immunofluorescence, was noted in a recent National Comprehensive Cancer Network (NCCN) Task Force Report on hormone receptor testing in breast cancer as one of the “… promising new strategies being developed for the measurement of ER and PgR in breast cancer tissue.”Experts from the country’s leading cancer treatment institutions responded in the report to growing concerns about hormone receptor testing in breast cancer by standard immunohistochemistry (IHC) methodology, particularly a high false-negative rate, and clarified how such testing can be improved. Hormone receptor testing, which includes estrogen receptor (ER) and progesterone receptor (PgR), is a standard part of the diagnostic characterization of an individual’s breast cancer and drives treatment decision making.”The NCCN Task Force Report demonstrates the growing confidence within oncology circles that AQUA analysis provides a new and promising approach to hormone receptor testing,” said Rana K. Gupta, CEO of HistoRx. “We believe the upcoming ASCO-CAP guidelines will reinforce the Task Force’s assessment that current methods of ER testing are flawed and will further underscore the need for a better solution. AQUA technology’s sensitivity, reproducibility and quantification improve upon standard immunohistochemistry testing and can play an important role in improving the overall accuracy of hormone receptor testing.”An early example of personalized medicine, ER testing and PgR testing are typically performed by standard IHC. AQUA? technology brings standardization and reproducibility to IHC analysis and is the only platform capable of precisely measuring protein biomarker concentration with subcellular resolution in tissue sections. This advance enables fully objective, standardized, reproducible, and automated analysis to guide targeted drug development and therapeutic decision making. AQUA’s proprietary software uses automated fluorescent image acquisition and data analysis to provide precise quantification of protein biomarkers of interest, including hormone receptors. HistoRx has developed ER and PgR tests based on AQUA? technology. Both of these assays have been used to analyze the TEAM trial, a randomized, international study of more than 9,000 postmenopausal women with hormone sensitive early breast cancer.Results from this analysis will be discussed at the San Antonio Breast Cancer Symposium (SABCS) in December 2009.

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