HistoRx achieves dominant IP position with digital pathology instrumentation

BRANFORD, Conn., Feb. 28, 2012 /PRNewswire/ — HistoRx, the leader in quantitative immunohistochemistry, has earned two additional patents covering AQUA technology and critical elements of digital microscopy standardization. Combined with patents earned previously, these issuances by the US Patent & Trademark Office advance the Company’s proprietary position in standardization of quantitative digital pathology to a dominant role in the industry.

Challenges associated with the generation of reproducible digital microscopy images and image data at the appropriate stringency for quantitative analysis are addressed by these newly issued patents. Digital pathology initially evolved to capture images of clinical samples interrogated through the microscope for telepathology, archival and research use. Today, however, in the research and clinical settings, digital microscopy images support image analysis as well. The image is the primary source of data used for the assessment of a variety of features of the clinical sample, from morphological characteristics to measurement of biomarker expression. Robust quantitative data can only be achieved from analysis of reproducible images, generated from standardized digital microscopy instruments. Digital pathology companies interested in making the leap from merely qualitative to truly quantitative analysis can ensure an effective transition to clinic-ready results through collaboration with HistoRx.

US Patent 8,121,794 “Systems and methods for automated analysis of cells and tissues,” issued February 21, 2012, and is the third US patent protecting methods and now, microscopy systems, that localize and quantitate a biomarker in subcellular compartments in a tissue sample, the hallmark of AQUA technology.
US Patent 8,120,768, “Method and system for standardizing microscope instruments,” also issued February 21, 2012, and is the third US patent protecting methods, software, and standardized microscopy systems that provide for the generation of reproducible digital microscopy images and image data at the appropriate stringency for quantitative analysis.

“Our patent position has evolved beyond AQUA technology to methods necessary for advancing digital microscopy images from images that are visually appealing to images that are suitable for quantitative analysis with the accuracy required for clinical results,” commented Wendy Davis, VP of Intellectual Property and Portfolio Management at HistoRx. “What can be measured can be managed. It was through the use of AQUA technology that the need to standardize microscopy systems and the images they generate was revealed. Therefore the 8,120,768 patent is broadly applicable to digital microscopy bringing its utility from generating images to generating quantitative clinical diagnostic results.”

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. Such precise determination of first, the location within the tumor cell and second, the amount in each location is not possible with conventional testing methods, such as standard immunohistochemistry (IHC). 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 120 peer-reviewed publications. AQUA technology is currently available on the ScanScope FL™ from Aperio and the Vectra™ 2 system from Caliper Life Sciences, a PerkinElmer company.

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. 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 www.historx.com.

SOURCE HistoRx, Inc.