Patents Assigned to EXACT SCIENCES DEVELOPMENT COMPANY, LLC
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Patent number: 11499179Abstract: A cleavage-based real-time PCR assay method is provided. In general terms, the assay method includes subjecting a reaction mixture comprising a) PCR reagents for amplifying a nucleic acid target, and b) flap cleavage reagents for performing a flap cleavage assay on the amplified nucleic acid target to two sets of thermocycling conditions. No additional reagents are added to the reaction between said first and second sets of cycles and, in each cycle of the second set of cycles, cleavage of a flap probe is measured.Type: GrantFiled: February 12, 2020Date of Patent: November 15, 2022Assignee: Exact Sciences Development Company, LLCInventors: Rebecca Oldham-Haltom, Hongzhi Zou, Graham P. Lidgard, Michael J. Domanico, Hatim Allawi
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Patent number: 11352674Abstract: Provided herein is reagent mixture comprising multiplexed amplification reagents and flap assay reagents for detecting, in a single reaction, mutant copies of the KRAS gene that contain any of the 34A, 34C, 34T, 35A, 35C, 35T or 38A point mutations. Methods that employ the reagent mix and kits for performing the same are also provided.Type: GrantFiled: March 10, 2020Date of Patent: June 7, 2022Assignee: Exact Sciences Development Company, LLCInventors: Rebecca Oldham-Haltom, Hatim Allawi, Hongzhi Zou, Michael J. Domanico, Graham P. Lidgard
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Patent number: 11307203Abstract: The present disclosure provides compositions and methods for using one or more polypeptide probes to profile an immune response. The polypeptide probe can be used to detect one or more antibodies from a sample. Furthermore, the present disclosure provides methods and compositions for characterizing a cancer based on the detection of one or more antibodies, such as autoantibodies.Type: GrantFiled: March 23, 2018Date of Patent: April 19, 2022Assignees: The Regents of the University of Michigan, Exact Sciences Development Company, LLCInventors: Arul M. Chinnaiyan, Xiaoju Wang, Alex Tsodikov, Jeanne Ohrnberger
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Patent number: 11208680Abstract: 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: July 19, 2017Date of Patent: December 28, 2021Assignee: Exact Sciences Development Company, LLCInventors: Hatim T. Allawi, Graham P. Lidgard, Brian Aizenstein, Melissa M. Gray
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Patent number: 11193168Abstract: 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: February 12, 2020Date of Patent: December 7, 2021Assignee: Exact Sciences Development Company, LLCInventors: Hatim T. Allawi, William G. Weisburg, Graham P. Lidgard, Michael W. Kaiser, Abram M. Vaccaro, Gracie Shea
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Patent number: 11149317Abstract: A method of detecting a predisposition to, or the incidence of, cancer in a sample comprises detecting an epigenetic change in at least one gene selected from an NDRG4/NDRG2 subfamily gene, GATA4, OSMR, GATA5, SFRP1, ADAM23, JPH3, SFRP2, APC, MGMT, TFPI2, BNIP3, FOXE1, SYNE1, SOX17, PHACTR3 and JAM3, wherein detection of the epigenetic change is indicative of a predisposition to, or the incidence of, cancer. Also described are pharmacogenetic methods for determining suitable treatment regimens for cancer and methods for treating cancer patients, based around selection of the patients according to the methods of the invention. The present invention is also concerned with improved methods of collecting, processing and analyzing samples, in particular body fluid samples. These methods may be useful in diagnosing, staging or otherwise characterizing various diseases.Type: GrantFiled: October 8, 2018Date of Patent: October 19, 2021Assignee: Exact Sciences Development Company, LLCInventors: Manon Van Engeland, Manon Adriaan De Bruine, Arjan Griffioen, Joost Louwagie, Katja Bierau, Gontran Brichard, Gaetan Otto, Maarten Penning
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Patent number: 11118230Abstract: Provided herein is technology relating to performing methylation assays. In particular, the technology relates to internal controls for methylation assays.Type: GrantFiled: June 20, 2018Date of Patent: September 14, 2021Assignees: Exact Sciences Development Company, LLC, Mayo Foundation for Medical Education and ResearchInventors: David Alan Ahlquist, William Russell Taylor, Douglas W. Mahoney, Graham P. Lidgard, Hatim T. Allawi, Abram Michael Vaccaro
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Patent number: 11118228Abstract: Provided herein is technology for neoplasia screening, and particularly, but not exclusively, to methods, compositions, and related uses for detecting the presence of cancer, in particular, colorectal cancer.Type: GrantFiled: January 26, 2018Date of Patent: September 14, 2021Assignees: Exact Sciences Development Company, LLC, Mayo Foundation for Medical Education and ResearchInventors: Hatim T. Allawi, Michael W. Kaiser, Graham P. Lidgard, William R. Taylor, Tamara J. Sander, Abram M. Vaccaro
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Patent number: 11104960Abstract: Provided herein is technology for esophageal disorder screening and particularly, but not exclusively, to methods, compositions, and related uses for detecting the presence of esophageal disorders (e.g., Barrett's esophagus, Barrett's esophageal dysplasia, etc.). In addition, the technology provides methods, compositions and related uses for distinguishing between Barrett's esophagus and Barrett's esophageal dysplasia, and between Barrett's esophageal low-grade dysplasia, Barrett's esophageal high-grade dysplasia, and esophageal adenocarcinoma within samples obtained through endoscopic brushing or nonendoscopic whole esophageal brushing or swabbing using a tethered device (e.g. such as a capsule sponge, balloon, or other device).Type: GrantFiled: September 13, 2019Date of Patent: August 31, 2021Assignees: Exact Sciences Development Company, LLC, Mayo Foundation for Medical Education and ResearchInventors: David A. Ahlquist, William R. Taylor, John B. Kisiel, Douglas W. Mahoney, Tracy C. Yab, Graham P. Lidgard, Hatim T. Allawi
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Patent number: 11091812Abstract: 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: September 12, 2019Date of Patent: August 17, 2021Assignee: EXACT SCIENCES DEVELOPMENT COMPANY, LLCInventors: Hongzhi Zou, Graham P. Lidgard, Michael J. Domanico, Hatim Allawi
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Patent number: 11078539Abstract: 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 colorectal cancer.Type: GrantFiled: March 26, 2015Date of Patent: August 3, 2021Assignees: Mayo Foundation for Medical Education and Research, Exact Sciences Development Company, LLCInventors: David A. Ahlquist, William R. Taylor, Douglas W. Mahoney, Graham P. Lidgard, Hatim T. Allawi
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Patent number: 10975443Abstract: Provided herein is technology for breast cancer screening and particularly, but not exclusively, to methods, compositions, and related uses for detecting the presence of breast cancer.Type: GrantFiled: November 28, 2018Date of Patent: April 13, 2021Assignees: Mayo Foundation for Medical Education and Research, Exact Sciences Development Company, LLCInventors: David A. Ahlquist, William R. Taylor, Douglas W. Mahoney, Tracy C. Yab, John B. Kisiel, Hatim T. Allawi, Graham P. Lidgard, Michael W. Kaiser
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Patent number: 10934594Abstract: Provided herein is technology for breast cancer screening and particularly, but not exclusively, to methods, compositions, and related uses for detecting the presence of breast cancer.Type: GrantFiled: November 28, 2018Date of Patent: March 2, 2021Assignees: Mayo Foundation for Medical Education and Research, Exact Sciences Development Company, LLCInventors: David A. Ahlquist, William R. Taylor, Douglas W. Mahoney, Tracy C. Yab, John B. Kisiel, Hatim T. Allawi, Graham P. Lidgard, Michael W. Kaiser
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Patent number: 10934592Abstract: 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: February 27, 2018Date of Patent: March 2, 2021Assignees: MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH, EXACT SCIENCES DEVELOPMENT COMPANY, LLCInventors: 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: 10883144Abstract: 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 colorectal cancer.Type: GrantFiled: January 9, 2020Date of Patent: January 5, 2021Assignees: Mayo Foundation for Medical Education and Research, Exact Sciences Development Company, LLCInventors: David A. Ahlquist, William R. Taylor, Douglas W. Mahoney, Graham P. Lidgard, Hatim T. Allawi
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Patent number: 10822638Abstract: 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: October 26, 2016Date of Patent: November 3, 2020Assignee: Exact Sciences Development Company, LLCInventors: 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: 10808286Abstract: A method of detecting a predisposition to, or the incidence of, cancer in a sample comprises detecting an epigenetic change in at least one gene selected from an NDRG4/NDRG2 subfamily gene, GATA4, OSMR, GATA5, SFRP1, ADAM23, JPH3, SFRP2, APC, MGMT, TFPI2, BNIP3, FOXE1, SYNE1, SOX17, PHACTR3 and JAM3, wherein detection of the epigenetic change is indicative of a predisposition to, or the incidence of, cancer. Also described are pharmacogenetic methods for determining suitable treatment regimens for cancer and methods for treating cancer patients, based around selection of the patients according to the methods of the invention. The present invention is also concerned with improved methods of collecting, processing and analyzing samples, in particular body fluid samples. These methods may be useful in diagnosing, staging or otherwise characterizing various diseases.Type: GrantFiled: May 4, 2018Date of Patent: October 20, 2020Assignee: EXACT SCIENCES DEVELOPMENT COMPANY, LLCInventors: Manon Van Engeland, Manon Adriaan De Bruine, Arjan Griffioen, Joost Louwagie, Katja Bierau, Gontran Brichard, Gaetan Otto, Maarten Penning
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Patent number: 10704081Abstract: 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: October 26, 2016Date of Patent: July 7, 2020Assignee: EXACT SCIENCES DEVELOPMENT COMPANY, LLCInventors: Graham P. Lidgard, Hatim Allawi
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Patent number: 10704083Abstract: 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: October 18, 2018Date of Patent: July 7, 2020Assignee: Exact Sciences Development Company, LLCInventors: Michael J. Domanico, Hatim Allawi, Graham P. Lidgard, Brian Aizenstein, Oliver Hunt, Tobias Charles Zutz
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Patent number: 10683555Abstract: 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 14, 2018Date of Patent: June 16, 2020Assignees: Mayo Foundation for Medical Education and Research, Exact Sciences Development Company, LLCInventors: David A. Ahlquist, John B. Kisiel, William R. Taylor, Tracy C. Yab, Douglas W. Mahoney, Graham P. Lidgard, Hatim T. Allawi