Flagship Biosciences, Inc.

Quest Diagnostics Investments, Inc.

US Genomics, Inc.

Steven J Potts

George David Young

Trevor Johnson

Frank Voelker

Charles M Strom

Donghui Huang

Jenny Ellen Rooke

Joseph Krueger

Holger Lange

Nathan T Martin

Erik Hagendorn

The disclosure concerns a method for measuring and reporting vascularity in a biological tissue sample. The method generally includes: within a digital image of a tissue section, (i) identifying endothelial cells, lymphatic cells, or a combination thereof; (ii) mapping one or more proximity regions, each of the proximity regions defining an area between detected vessels and a first distance outwardly therefrom; and (iii) calculating one or more of: a vessel proximity score or a hypoxia score, wherein the vessel proximity score relates a composition of objects within the proximity regions, and wherein the hypoxia score relates a composition of tissue within or outside of the proximity regions, respectively.

Methods for measuring and reporting vascularity in a tissue sample

The invention concerns automated methods for assessing tissue morphometry in digital images of tissue sections derived from small intestine biopsy samples from patients submitted for evaluation of celiac disease. The methods generally involve digital image analysis of tissue section images, and specifically involve post-processing each image to produce a binary mask capturing the tissue area footprint on the glass slide. Virtual stereology probes are placed on each image and assessed to estimate the ratio of the surface area to volume of the tissue specimen. The surface area to volume ratio is used to diagnose celiac disease and make inferences about the severity of celiac disease in those individuals with a positive diagnosis of celiac disease.

Automated methods for assessment of celiac disease

The instant disclosure describes a method for measuring and reporting vascularity in a biological tissue sample. The method generally includes: within a digital image of a tissue section, (i) identifying endothelial cells, lymphatic cells, or a combination thereof; (ii) mapping one or more proximity regions, each of the proximity regions defining an area between detected vessels and a first distance outwardly therefrom; and (iii) calculating one or more of: a vessel proximity score or a hypoxia score, wherein the vessel proximity score relates a composition of objects within the proximity regions, and wherein the hypoxia score relates a composition of tissue within or outside of the proximity regions, respectively.

Feature analysis on consecutive tissue sections (FACTS) includes obtaining a plurality of consecutive tissue sections from a tissue sample, staining the sections with at least one biomarker, obtaining a digital image thereof, and identifying one or more regions of interest within a middle of the consecutive tissue sections. The digital images of the consecutive tissue sections are registered for alignment and the one or more regions of interest are transferred from the image of the middle section to the images of the adjacent sections. Each image of the consecutive tissue sections is then analyzed and scored as appropriate. Using FACTS methods, pathologist time for annotation is reduced to a single slide. Optionally, multiple middle sections may be annotated for regions of interest and transferred accordingly.

Methods for feature analysis on consecutive tissue sections

Methods for cell-based tissue analysis utilize modern trends in digital microscopy to obtain, process, calibrate, and analyze digital images of tissue sections to quantify cell-based data for improved histological analysis. Using data from multiple images of a common tissue section, or data from images of multiple tissue sections, additional degrees of freedom are realized and the resulting analysis provides added depth to histological analysis of tissue samples. With computerized analytical methods, speed and accuracy of histological analysis is greatly improved.

Cell-based tissue analysis

The present invention provides methods of determining the size of a particular nucleic acid segment of interest in a sample of nucleic acids through fragmentation of DNA, size fractionation, an optional second fragmentation, and identification using a marker sequence. In particular aspects, an expansion or reduction of tandem repeat sequences can be detected. In further aspects, carriers and individuals afflicted with fragile X syndrome or other diseases associated with tandem repeats can be distinguished from normal individuals.

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Anthem, AZ, United States of America

Steven J Potts