HistoRx AQUA® Technology Identifies Two Biomarkers Linked to Lung Cancer Survival

— Study by researchers at H. Lee Moffitt Cancer Center published in The New England Journal of Medicine underscores prognostic potential of AQUA-based assays—

NEW HAVEN, Conn., February 22, 2007—High expression of a combination of the RRM1 and ERCC1 proteins has been shown to be associated with increased lung cancer survival rates, according to a study by researchers from the H. Lee Moffitt Cancer Center & Research Institute published in today’s issue of The New England Journal of Medicine.

The research team, led by Gerold Bepler, MD, PhD, Professor of Medicine and Oncology at Moffitt, used the HistoRx PM-2000™ instrument and AQUA® technology to measure expression levels of RRM1 (the regulatory subunit of ribonucleotide reductase) and ERCC1 (excision repair cross complementation group 1 protein) in tumors from 187 patients with early-stage non-small-cell lung cancer. The investigators measured the proteins using fluorescent immunohistochemistry on the HistoRx PM-2000 image analysis platform and analyzed them using AQUA algorithms. The in situ biomarker profiling system generated quantitative measurements of patient protein levels based on AQUA scores derived from fluorescent output of labeled markers. The scores were then correlated with patient survival.

The researchers concluded that the combination of RRM1 and ERCC1 is a determinant of survival for patients in the high expression group, with the overall survival of patients in the high expression group more than twice that of patients in the low expression group.
 
“AQUA technology is a breakthrough in immunohistochemistry,” said Dr. Bepler, discussing the impact the technology had on his research. “Proteins are not simply present or absent in cells; there is a gradual and contextual importance that cannot be addressed by routine immunohistochemistry. AQUA is an outstanding platform for translational research.” 

“HistoRx is delighted that Dr. Bepler, one of the first members of our HARP institutional research program, has used our technology to make this advance in biomarker research,” said Rana Gupta, CEO of HistoRx. “HistoRx is dedicated to the development of AQUA-based diagnostic tests that provide prognostic value in the field of cancer. This exciting work by Dr. Bepler validates this strategy.”

The study is published in the February 22, 2007 issue of The New England Journal of Medicine. Co-authors on the study include Zhong Zheng, Tingan Chen, Xueli Li, Eric Haura, Anupama Sharma, and Gerold Bepler.

About the HARP™ Program
The HistoRx Academic Research Program (HARP) provides oncologists and pathologists at leading academic research institutions in North America and Europe access to the AQUA® technology for use exclusively in noncommercial research. Academic and other not-for-profit research institutions are eligible for the HARP program. Membership benefits include noncommercial use of the AQUA platform (system components: AQUA tissue analysis software and PM-2000 image analyzer).

About HistoRx
HistoRx is developing and commercializing pioneering quantitative histopathology technology that provides exceptional measurement and localization of protein biomarkers in their natural context within tissue. The HistoRx proprietary AQUA® technology is the first platform capable of measuring biomarker concentration with subcellular resolution to generate more precise, efficient, and cost-effective answers about the safety and effectiveness of new therapeutics in development as well as enable the development of companion diagnostic tests for targeted therapies. HistoRx services are used by pharmaceutical and biotechnology companies throughout discovery research, preclinical studies, and clinical drug development. HistoRx companion diagnostic products are linked to our partners’ drug candidates in development to predict therapeutic outcome. HistoRx also pursues internal programs to develop proprietary standard-of-care diagnostics that offer substantial improvements over existing immunohistochemistry-based tests.

About H. Lee Moffitt Cancer Center & Research Institute (www.moffitt.org)
Located in Tampa, Florida on the University of South Florida campus, H. Lee Moffitt Cancer Center & Research Institute is the only Florida-based cancer center with the NCI designation as a Comprehensive Cancer Center for its excellence in research and contributions to clinical trials, prevention and cancer control. Moffitt currently has 15 affiliates in Florida, one in Georgia and two in Puerto Rico. Additionally, Moffitt is a member of the National Comprehensive Cancer Network, a prestigious alliance of the country’s leading cancer centers, and is listed in U.S. News & World Report as one of America’s Best Hospitals for cancer. Moffitt’s sole mission is to contribute to the prevention and cure of cancer.

To Read the Article visit the New England Journal of Medicine at http://content.nejm.org/cgi/content/short/356/8/800