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HistoRx Earns Patent on Quantitative Immunoassay Optimization

Tuesday, February 21, 2012

Branford, CT -- HistoRx, the leader in quantitative immunohistochemistry (IHC), advances its proprietary position in measurement of biomarkers in tissue through today's issuance of US Patent 8,121,365 protecting the company's "Methods and systems for determining optimal dilution of a reagent." As the first in what HistoRx expects will be a series of broadening patents pertaining to its quantitative methodology, this patent protects the company's capabilities in optimizing antibody concentration for quantitative immunoassays, methods required to generate high-quality reproducible clinical diagnostic results that precisely relate to biomarker concentrations in tissue sections.

HistoRx is developing diagnostic assays that bring the technical precision of clinical pathology to the anatomic pathology setting: objective, quantitative and reproducible results for biomarkers in biopsy specimens should be available to all patients and clinicians as readily as accurate measurements of glucose in blood. In addition to the company's cutting-edge proprietary AQUA® technology, HistoRx is uniquely addressing other aspects of the pre-analytic and analytic phases of biomarker assessment in anatomic pathology. While reagent performance is assessed subjectively in traditional IHC methodology, the techniques covered in this patent optimize the range of the assay analytically, which provides superior results regardless of analytical platform.

"Analytical precision is a prerequisite for clinical accuracy," said Mark Gustavson, Ph.D., Director of Operations at HistoRx and one of the inventors. "This patent is further recognition of HistoRx's leading approach to achieving objectivity and reproducibility in anatomic pathology."

AQUA technology is an automated, quantitative IHC testing method that enables measurement of protein biomarkers in tissue as an aid to a pathologist's diagnosis. AQUA analysis is used in cancer research by more than twenty leading academic centers worldwide, is part of the clinical development plans for oncology drug candidates from several major pharma companies, and has been cited in more than 120 peer-reviewed publications. In the clinical diagnostic setting Genoptix Medical Labs, a Novartis company, has commercialized diagnostic tests based on AQUA technology licensed from HistoRx. AQUA software is currently compatible with the ScanScopeFL from Aperio and the Vectra 2 system from Caliper Life Sciences.

About HistoRx, Inc.

HistoRx, Inc. is the leader in quantitative immunohistochemistry and a leading developer of tissue-based diagnostic solutions to advance individualized patient care. The company's products and services are based on proprietary analysis of tissue biomarkers using AQUA® technology. AQUA® technology is the only platform capable of precisely measuring protein biomarker concentration with sub-cellular resolution in tissue sections, enabling fully objective, standardized, reproducible, and automated analysis to guide drug development and therapeutic decision-making. HistoRx is commercializing a pipeline of proprietary diagnostic products targeting improved treatment decision-making and patient outcomes in cancer care. For more information, please visit

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