HistoRx, Inc., announced today that the U.S. Patent and Trademark Office has granted a patent protecting the company's methods for standardization of digital microscopy instruments in order to go beyond imaging to generating high-quality reproducible data that precisely relates to biomarker concentrations in tissue sections.
Digital pathology involves taking digital pictures of an anatomic pathology specimen, a slide with cells or a thinly-sliced piece of tissue, and managing the interpretation and storage of the resulting images. While most companies involved in digital pathologyemphasize generation and storage of images for interpretation, HistoRx is the only company to bring reproducibility, or standardization, to those images, to quantify protein in tissue for accurate biomarker measurement.
"This patent covers HistoRx's unique ability to ensure that multiple instruments performing the same test, whether in one or many locations, can give the same result for a patient's slide," said Jason Christiansen, Senior Director of Operations at HistoRx and the lead inventor. "We don't make digital microscopy systems, we make digital microscopy systems better."
Quantitative IHC (qIHC) is only as good as the image from which the data is derived. Robust quantitative data can only be achieved from reproducible images, generated with information from standardized digital microscopy instruments. HistoRx is the first company to address standardization of digital microscopy instruments to deliver high quality reproducible data that precisely relates to biomarker concentrations in tissue sections -- data that is essential to the development and delivery of personalizedcancer care.
The patented approach applies to qIHC, as well as all uses of digital microscopy and establishes the definition for standardization and reproducibility in both brightfield and fluorescent digital pathology.
U.S. Patent No. 7,907,271 is the first assigned to HistoRx and is entitled "Method and System for Standardizing Microscope Instruments." Inventors Jason Christiansen,Robert Pinard, Maciej Zerkowski and Greg Tedeschi are all current or former employees of the company.
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 any other method, digital or otherwise. AQUA analysis is used in cancer research by 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. The first use of AQUA technology in the clinical diagnostic setting occurred in 2010 with the launch by Genoptix Inc. (a subsidiary of Novartis) of diagnostic tests based on AQUA technology licensed from HistoRx. AQUA technology is currently available on the ScanScope FL™ from Aperio and will be available later this year on the Nuance™ and Vectra™ systems from Caliper Life Sciences.