HistoRx, the leader in quantitative immunohistochemistry, advances its proprietary position in digital pathology through the recent issuance of US patents covering key features necessary for achievement of reproducible, standardized image analysis results. The U.S. Patent and Trademark Office has granted two new patents protecting the company's methods for standardization of digital microscopy instruments, methods required to generate high-quality reproducible clinical diagnostic data that precisely relates to biomarker concentrations in tissue sections.
For patient tissue specimens stained for a biomarker such as HER2, HistoRx believes that physicians and patients expect the same quantitative result regardless of the digital microscopy instrument used. To achieve this, HistoRx evaluated sources of variability in digital scanning microscopy instrumentation that affect results. One source of variability is the light source; a second is the path traveled by the light through each instrument. By correcting for each of these, HistoRx achieved exceptionally high levels of reproducibility for an assay previously thought to be incapable of true standardization: with AQUA® technology, the same slide of breast cancer specimens stained for HER2 analyzed across five instruments standardized by this method attained a coefficient of variance of less than 5% (where typical variances are ~20%).
"These patents reinforce the value of HistoRx's unique approach to achieving objectivity and reproducibility in anatomic pathology," said Mark Gustavson, Ph.D., Director of Operations at HistoRx and one of the inventors. "You cannot have clinical accuracy without analytical precision."
US Patent 7,978,258, issued to HistoRx on July 12, 2011, is entitled "Automatic Exposure Time Selection for Imaging Tissue" and pertains to methods for determining appropriate exposure time for acquiring digital images intended for image analysis to generate quantitative results. Exposure times are most commonly determined to optimize contrast and visual appeal of the image, and may be determined 'by eye.' The human eye is a poor judge of intensity, and images generated by conventionally determined exposure times are commonly too overexposed for generating quantitative results. The patented methods automatically determine the appropriate exposure time to maximize for a broad range of pixel intensities in the image, thereby maximizing the dynamic range of quantitative measurements achievable from subsequent image analysis.
US Patent 8,027,030, issued to HistoRx on September 26, 2011, is entitled "Methods and System for Standardizing Microscope Systems," and pertains to hardware that can be inserted into the digital imaging fluorescent microscopy system, similar to filter cubes used in fluorescence microscopy, and provides for the monitoring of the light source and its fluctuation.
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 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. 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 Vectra™ system from Caliper Life Sciences.
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