At the San Antonio Breast Cancer Symposium (SABCS) held this weekend a study conducted by HistoRx Inc and the University of Calgary was selected for discussion by the breast cancer specialists assembled for the conference. This study of 568 patients treated at the University of Calgary had several clinically relevant conclusions.

The study results showed that quantification of ER expression by AQUA analysis, an automated, quantitative IHC testing method that enables measurement of protein biomarkers in tissue as an aid to a pathologist’s diagnosis, can provide a continuous recurrence risk assessment for patients being treated with tamoxifen. The study also showed that Low level ER expressing patients show significant benefit from radiation treatment whereas radiation treatment showed no benefit in high-level ER-expressing patients and that response to radiation treatment can be predicted by quantification of ER expression.

The study was designed to assess the objectivity and reproducibility of AQUA technology across institutions and across instrument platforms, and it found that “AQUA analysis, unlike any other system for measurement of in situ protein expression, can be standardized across platforms, operators and staining runs.”[1]

“There is a critical need for highly standardized and quantitative measurement of protein biomarkers in tissue specimens, particularly for estrogen receptor which is a key determinant of first-line therapy in breast cancer,” stated Tony Magliocco, MD, Associate Professor in the Departments of Pathology and Laboratory Medicine and Oncology at the University of Calgary, one of the authors of the study. “Laboratories throughout North America have discovered a significant lack of reproducibility in ER testing, and the AQUA platform may provide a solution to the problem.”

The evaluation was conducted on a cohort of retrospectively collected breast cancer specimens from patients treated with tamoxifen with or without radiotherapy. The investigators hope to confirm the clinical findings in a second study with a prospectively assembled patient population, ideally from a cooperative group or other multi-institutional trial.

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“HistoRx is pleased to see the data confirm our efforts in producing an objective, quantitative and reproducible measurement of ER in patient specimens,” commented Jason Christiansen, Ph.D., Senior Director of Operations for HistoRx and another author of the paper. “We were delighted to have the additional findings on disease recurrence and radiation response, and will follow up with the appropriate trials to confirm them.”

AQUA analysis is used in cancer research by more than twenty leading academic centers worldwide, is part of the clinical development plans for more than ten drug candidates from major pharma companies, and has been cited in more than 90 peer-reviewed publications. ER testing services using AQUA analysis are currently available from Genoptix Inc. which has licensed the technology from HistoRx for this application.

[1] “Quantitative and Standardized Measurement of Estrogen Receptor Predicts Response to Radiation Therapy in Breast Cancer,” Gustavson et al. SABCS Poster Discussion, December 11, 2010.

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