Bladder cancer detection composition, kit, and associated methods
Inventors
Goodison, Steven • Rosser, Charles J.
Assignees
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Publication Number
US-9964542-B2
Publication Date
2018-05-08
Expiration Date
Abstract
Compositions, kits, and methods for the diagnosis, prognosis, and monitoring of bladder cancer in a subject are provided by detecting in a urine sample a combination of biomarkers. In one embodiment of the invention, biomarker panels consisting of individual targets listed in Tables 4 through 10 may be detected. In another embodiment of the invention, multiplex biomarker panels of various composition, but including those biomarkers listed above may be detected.
Core Innovation
The disclosed invention relates to urine-based detection of bladder cancer using multiplex biomarker panels. A urine sample is obtained from a subject previously diagnosed with bladder cancer and is used in diagnostic workflows that assess multiple biomarkers simultaneously.
The document discloses biomarker panel detection approaches that include contacting a urine sample with a panel of antibodies that bind to proteins and form antibody-protein complexes, followed by detecting the presence and quantity of the complexes in the biological sample. In the provided claim context, the antibody panel includes antibodies that bind to Interleukin-8 (IL8), Angiogenin (ANG), Plasminogen active inhibitor 1 (PAII), Matrix metallopeptidase 10 (MMP10) and Apolipoprotein E (APOE).
The disclosure also reports development and validation of diagnostic gene signatures derived from exfoliated urothelial cells and naturally voided urine, including a 14-gene classifier and a constrained 9-gene upregulated-gene signature. The document further describes a urine protein biomarker panel assessed by ELISA, reporting individual biomarker performance and multivariate panel performance for combinations and reduced panels.
Beyond detection, the disclosure describes prognostic and monitoring uses based on biomarker levels and integration into kits/compositions with antibody binding and complex detection workflows, in addition to nucleic-acid approaches (qPCR/TLDA) for gene signature assessment.
Claims Coverage
The independent claim family member identified (clm-00001) covers a urine-based antibody multiplex assay for detecting antibody-protein complexes for a defined set of proteins in subjects previously diagnosed with bladder cancer, yielding diagnostic protein-quantity information. The dependent claims add refinements regarding subject criteria and urine composition.
Urine sample from previously diagnosed bladder cancer subject
Obtaining a urine sample from a subject previously diagnosed with bladder cancer.
Multiplex antibody panel detecting protein-antibody complexes
Contacting the urine sample with a panel of antibodies comprising antibodies that bind to, and form a complex with, each of the proteins in the group consisting of Interleukin-8 (IL8), Angiogenin (ANG), Plasminogen active inhibitor 1 (PAII), Matrix metallopeptidase 10 (MMP10) and Apolipoprotein E (APOE).
Detecting presence and quantity of protein-antibody complexes
Detecting the presence and quantity of the protein-antibodies complexes that form in the biological sample.
Subject having bladder cancer symptoms
Obtaining the sample from a subject who has one or more symptoms of bladder cancer.
Urine contains blood
Using a urine sample that contains blood.
Overall, the claim coverage focuses on multiplex detection of defined bladder-cancer-related protein targets by assaying antibody-protein complexes formed in urine, with dependent refinements for symptom-defined subject selection and blood-containing urine.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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