Patents Assigned to Exact Sciences Corporation
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Patent number: 11970746Abstract: A method of processing a fecal sample from a human subject comprising combining a first portion of a collected fecal sample with a stabilizing buffer, combining a second portion of the sample with a solution that prevents denaturation or degradation of blood proteins found in a fecal sample. Embodiments comprise testing nucleic acid extracted from the first portion of the fecal sample for an amount of a human nucleic acid, and testing the second portion of the fecal sample for the presence of human blood.Type: GrantFiled: March 7, 2023Date of Patent: April 30, 2024Assignee: Exact Sciences CorporationInventor: Joost Louwagie
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Patent number: 11952633Abstract: The present invention relates to methods and compositions for determination of and uses of specific methylation patterns indicative of adenoma and carcinoma. In particular, the invention relates to analysis of defined CpG loci that are coordinately methylated in DNAs from cancer and adenoma samples, methods for identifying coordinately methylated loci, and methods of using analysis of coordinately methylated loci in one or more marker regions in the design of assays for adenoma and cancer.Type: GrantFiled: November 23, 2020Date of Patent: April 9, 2024Assignees: Exact Sciences Corporation, Mayo Foundation for Medical Research and EducationInventors: David A. Ahlquist, William R. Taylor, Hongzhi Zou, Graham P. Lidgard
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Patent number: 11952615Abstract: The present invention provides synthetic DNA strands that find use as process controls in DNA processing and nucleic acid testing methods. In particular, provided herein are synthetic methylated DNA strands of known composition for use as control molecules in DNA testing, e.g., of mutations and/or methylation of DNA isolated from non-fish samples, such as human samples.Type: GrantFiled: November 18, 2021Date of Patent: April 9, 2024Assignee: Exact Sciences CorporationInventors: Hatim T. Allawi, Graham P. Lidgard, Brian Aizenstein, Melissa M. Gray
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Patent number: 11859254Abstract: Provided herein is technology relating to detecting neoplasia and particularly, but not exclusively, to methods, compositions, and related uses for detecting premalignant and malignant neoplasms such as gastric cancer.Type: GrantFiled: February 5, 2020Date of Patent: January 2, 2024Assignees: MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH, Exact Sciences CorporationInventors: David A. Ahlquist, William R. Taylor, John B. Kisiel, Tracy C. Yab, Douglas W. Mahoney, Hatim T. Allawi
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Patent number: 11845995Abstract: A method of sample analysis is provided. In certain embodiments, the method involves: a) amplifying a product from a sample that comprises both wild type copies of a genomic locus and mutant copies of the genomic locus that have a point mutation relative to said wild type copies of the genomic locus, to produce an amplified sample, where: i. the amplifying is done using a first primer and a second primer; and ii. the first primer comprises a 3? terminal nucleotide that base pairs with the point mutation and also comprises a nucleotide sequence that is fully complementary to a sequence in the locus with the exception of a single base mismatch within 6 bases of the 3? terminal nucleotide; and b) detecting the presence of said product in said amplified sample using a flap assay that employs an invasive oligonucleotide. A kit for performing the method is also provided.Type: GrantFiled: July 8, 2021Date of Patent: December 19, 2023Assignee: Exact Sciences CorporationInventors: Hongzhi Zou, Graham P. Lidgard, Michael J. Domanico, Hatim Allawi
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Patent number: 11845991Abstract: A method of processing a fecal sample from a human subject comprising removing a portion of a collected fecal sample and adding the removed portion of the sample to a buffer that prevents denaturation or degradation of blood proteins found in the sample, and detecting the presence of human blood in the removed portion of the fecal sample. The method further comprises stabilizing the remaining portion of the fecal sample.Type: GrantFiled: June 27, 2017Date of Patent: December 19, 2023Assignee: Exact Sciences CorporationInventor: Joost Louwagie
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Patent number: 11821039Abstract: Provided herein is technology relating to detecting neoplasia and particularly, but not exclusively, to methods, compositions, and related uses for detecting premalignant and malignant neoplasms such as pancreatic and colorectal cancer.Type: GrantFiled: May 12, 2020Date of Patent: November 21, 2023Assignees: Mayo Foundation for Medical Education and Research, Exact Sciences CorporationInventors: David A. Ahlquist, John B. Kisiel, William R. Taylor, Tracy C. Yab, Douglas W. Mahoney, Graham P. Lidgard, Hatim T. Allawi
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Patent number: 11814670Abstract: Provided herein is technology related to the chemical modification and purification of DNA. Specifically, the technology provides methods for performing a bisulfite conversion reaction on small amounts of single-stranded, fragmented DNA and performing the subsequent desulfonation and purification steps on magnetic beads.Type: GrantFiled: May 29, 2020Date of Patent: November 14, 2023Assignee: Exact Sciences CorporationInventors: Michael J. Domanico, Hatim Allawi, Graham P. Lidgard, Brian Aizenstein, Oliver Hunt, Tobias Charles Zutz
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Patent number: 11801511Abstract: Provided herein is technology relating to collecting and containing samples and particularly, but not exclusively, to technology for collecting and containing a stool specimen. The technology provides a device for collecting and containing a stool specimen, the device comprising ergonomic features optimized for a geriatric user. The technology also provides an enclosing holder for securing the ergonomic stool specimen container in a leak-proof manner e.g., during mechanical shaking.Type: GrantFiled: November 6, 2020Date of Patent: October 31, 2023Assignee: Exact Sciences CorporationInventors: Joseph E. Schiestle, Krystal A. Burger, Timothy A. Parmer, Jad A. Lunde, Sam M. Jang, David A. Schuelke, David B. Wolgemuth, Jing Yang Lu
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Patent number: 11746384Abstract: Provided herein is technology relating compositions and methods for detecting tissue cell-specific DNA, such as epithelial cell-specific DNA, in blood or blood products from a subject. The technology also relates to use of tissue cell-specific DNAs as internal controls for methylation assays.Type: GrantFiled: October 28, 2019Date of Patent: September 5, 2023Assignee: EXACT SCIENCES CORPORATIONInventors: Hatim T. Allawi, Graham P. Lidgard
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Patent number: 11708603Abstract: Provided herein is technology relating to the amplification-based detection of nucleic acids and particularly, but not exclusively, to methods and compositions for minimizing variability in the activity between different samples or manufacturing lots of DNA polymerases, such as Taq DNA polymerase.Type: GrantFiled: February 11, 2021Date of Patent: July 25, 2023Assignee: Exact Sciences CorporationInventors: Hatim Allawi, Rebecca Oldham-Haltom, Zubin Gagrat, Michael Domanico, Graham Lidgard
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Patent number: 11703512Abstract: A stool resuspension solution comprising a hemoglobin stabilization reagent is provided. In some embodiments, the hemoglobin stabilization reagent may be an osmolyte, a polyvalent cation, a sugar or polysaccharide and, optionally, a polyvalent cation, a protoporphyrin, or an HRP stabilization component and, optionally, a polyvalent cation. A method of stabilizing hemoglobin in a stool sample in the solution is also provided, as well as a sample collection device containing the solution.Type: GrantFiled: June 6, 2022Date of Patent: July 18, 2023Assignee: Exact Sciences CorporationInventors: Keith D. Fourrier, Jacquelyn T. Hennek, Michael J. Domanico, William G. Weisburg, Graham P. Lidgard, Kathleen S. Harings, Daniel J. Simpson
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Patent number: 11702704Abstract: Provided herein is technology for ovarian cancer screening and particularly, but not exclusively, to methods, compositions, and related uses for detecting the presence of ovarian cancer and sub-types of ovarian cancer (e.g., clear cell ovarian cancer, endometrioid ovarian cancer, mucinous ovarian cancer, serous ovarian cancer).Type: GrantFiled: October 30, 2020Date of Patent: July 18, 2023Assignees: Mayo Foundation for Medical Education and Research, Exact Sciences CorporationInventors: William R. Taylor, John B. Kisiel, Douglas W. Mahoney, David A. Ahlquist, Hatim T. Allawi, Michael W. Kaiser
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Patent number: 11697853Abstract: Provided herein is technology for prostate cancer screening and particularly, but not exclusively, to methods, compositions, and related uses for detecting the presence of prostate cancer.Type: GrantFiled: January 8, 2021Date of Patent: July 11, 2023Assignees: Mayo Foundation for Medical Education and Research, Exact Sciences CorporationInventors: David A. Ahlquist, William R. Taylor, John B. Kisiel, Tracy C. Yab, Douglas W. Mahoney, Brian A. Dukek, Matthew T. Gettman, Hatim T. Allawi
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Patent number: 11685956Abstract: A method for detecting a methylated genomic locus is provided. In certain embodiments, the method comprises: a) treating a nucleic acid sample that contains both unmethylated and methylated copies of a genomic locus with an agent that modifies cytosine to uracil to produce a treated nucleic acid; b) amplifying a product from the treated nucleic acid using a first primer and a second primer, wherein the first primer hybridizes to a site in the locus that contain methylcytosines and the amplifying preferentially amplifies the methylated copies of the genomic locus, to produce an amplified sample; and c) detecting the presence of amplified methylated copies of the genomic locus in the amplified sample using a flap assay that employs an invasive oligonucleotide having a 3? terminal G or C nucleotide that corresponds to a site of methylation in the genomic locus.Type: GrantFiled: February 8, 2021Date of Patent: June 27, 2023Assignee: Exact Sciences CorporationInventors: Graham P. Lidgard, Michael J. Domanico, Hatim Allawi, Hongzhi Zou
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Patent number: 11674169Abstract: Provided herein is technology relating to isolating nucleic acids. In particular, the technology relates to methods and kits for extracting nucleic acids from problematic samples such as stool.Type: GrantFiled: September 29, 2020Date of Patent: June 13, 2023Assignee: Exact Sciences CorporationInventors: Janelle J. Bruinsma, Michael J. Domanico, Graham P. Lidgard, Hongzhi Zou, William G. Weisburg, Hemanth D. Shenoi, James P. Light, II, Keith Kopitzke, John Zeis
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Patent number: 11674186Abstract: The present invention provides synthetic DNA strands that find use as controls or in nucleic acid testing methods. In particular, provided herein are synthetic DNA strands of known composition for use as control molecules in stool DNA testing, e.g., of mutations and/or methylation of DNA isolated from stool samples.Type: GrantFiled: December 3, 2020Date of Patent: June 13, 2023Assignee: Exact Sciences CorporationInventors: Ilse A. Tyler, Keith Yaeger, Michael J. Domanico, Hatim Allawi, Graham P. Lidgard
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Patent number: 11674168Abstract: Provided herein is technology relating to the amplification-based detection of bisulfite-treated DNAs and particularly, but not exclusively, to methods and compositions for multiplex amplification of low-level sample DNA prior to further characterization of the sample DNA. The technology further provides methods for isolating DNA from blood or blood product samples, e.g., plasma samples.Type: GrantFiled: September 24, 2020Date of Patent: June 13, 2023Assignee: Exact Sciences CorporationInventors: Hatim Allawi, Graham P. Lidgard, Brian Aizenstein, Tamara J. Sander, Maria Giakoumopoulos, Michael W. Kaiser, Melissa M. Gray, Abram Michael Vaccaro
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Patent number: 11479823Abstract: Provided herein is technology for lung neoplasia screening and particularly, but not exclusively, to methods, compositions, and related uses for detecting the presence of lung cancer.Type: GrantFiled: October 23, 2020Date of Patent: October 25, 2022Assignee: Exact Sciences CorporationInventors: Hatim Allawi, Graham P. Lidgard, Chateen Krueger, Michael W. Kaiser, Tamara J. Sander
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Patent number: 11385243Abstract: A stool resuspension solution comprising a hemoglobin stabilization reagent is provided. In some embodiments, the hemoglobin stabilization reagent may be an osmolyte, a polyvalent cation, a sugar or polysaccharide and, optionally, a polyvalent cation, a protoporphyrin, or an HRP stabilization component and, optionally, a polyvalent cation. A method of stabilizing hemoglobin in a stool sample in the solution is also provided, as well as a sample collection device containing the solution.Type: GrantFiled: March 15, 2019Date of Patent: July 12, 2022Assignee: EXACT SCIENCES CORPORATIONInventors: Keith D. Fourrier, Jacquelyn T. Hennek, Michael J. Domanico, William G. Weisburg, Graham P. Lidgard, Kathleen S. Harings, Daniel J. Simpson