Methods for detecting oncofetal fibronectin

• US 9,513,298 B2
• Filed: 10/06/2014
• Issued: 12/06/2016
• Est. Priority Date: 07/30/2004
• Status: Active Grant

• Current Assignee: Hologic Incorporated
• Original Assignee: Hologic Incorporated
• Inventors: Hussa, Robert, Fischer-Colbrie, Mark, LaPointe, Jerome P., Shorter, Simon, Senyei, Andrew
• Primary Examiner(s): Reddig, Peter J
• Assistant Examiner(s): AKHOON, KAUSER M
• Application Number:
  US14/507,079
• Publication Number:
  US 20150044708A1
• Time in Patent Office: 792 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61P 15/04 for inducing labour or abortion; Uterotonics
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: B82Y 10/00 Nanotechnology for information processing, storage or transmission, e.g. quantum computing or single electron logic
• CPC Class Codes: B82Y 30/00 Nanotechnology for materials or surface science, e.g. nanocomposites
• CPC Class Codes: B82Y 5/00 Nanobiotechnology or nanomedicine, e.g. protein engineering or drug delivery
• CPC Class Codes: C07K 16/18 against material from animals or humans
• CPC Class Codes: C07K 16/30 from tumour cells
• CPC Class Codes: C12Q 1/6834 Enzymatic or biochemical coupling of nucleic acids to a solid phase
• CPC Class Codes: C12Q 1/6883 for diseases caused by alterations of genetic material
• CPC Class Codes: C12Q 1/6886 for cancer immunoassay for cancer G01N33/574
• CPC Class Codes: C12Q 2600/106 Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism
• CPC Class Codes: C12Q 2600/112 Disease subtyping, staging or classification
• CPC Class Codes: G01N 2333/471 Pregnancy proteins, e.g. placenta proteins, alpha-feto-protein, pregnancy specific beta glycoprotein
• CPC Class Codes: G01N 2333/78 Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin, cold insoluble globulin [CIG]
• CPC Class Codes: G01N 2500/00 Screening for compounds of potential therapeutic value
• CPC Class Codes: G01N 2800/36 Gynecology or obstetrics
• CPC Class Codes: G01N 2800/368 Pregnancy complicated by disease or abnormalities of pregnancy, e.g. preeclampsia, preterm labour
• CPC Class Codes: G01N 33/564 for pre-existing immune complex or autoimmune disease , i.e. systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, rheumatoid factors or complement components C1-C9
• CPC Class Codes: G01N 33/57476 involving oncofetal proteins
• CPC Class Codes: G01N 33/6887 from muscle, cartilage or connective tissue
• CPC Class Codes: G01N 33/689 : related to pregnancy or the gonads

Abstract

Methods and products for the detection of oncofetal fibronectin indicating molecules in samples are provided. Methods for imaging of oncofetal fibronectin are provided. In some methods provided herein, the sample is treated with a reagent and/or contacted with a non-specific binder. Provided are methods for testing subjects to ascertain health and disease status and to assess the risk of developing a disease or condition. Methods for detecting the presence of oncofetal fibronectin indicating molecules by a variety of methods such as immunoassays and mass spectrometry also are provided. Methods and products for detection of oncofetal fibronectin for selection of concept are provided.

Claims

1. A method for classifying the level of oncofetal fibronectin protein in a cervicovaginal sample, comprising:

measuring the amount of oncofetal fibronectin protein in said sample taken from an asymptomatic patient at less than 25 weeks gestation, wherein the amount of oncofetal fibronectin protein in said sample is determined using the monoclonal antibody FDC-6;

comparing the amount of oncofetal fibronectin protein in said sample to a threshold level of 200 ng/ml; and

classifying the amount of oncofetal fibronectin protein in said sample according to said threshold level, whereby classification of oncofetal fibronectin protein in said sample above said threshold identifies the likelihood successful induction of labor.

2. A method for classifying the level of oncofetal fibronectin protein in a cervicovaginal sample, comprising:

measuring the amount of oncofetal fibronectin protein in said sample taken from an asymptomatic patient at less than 25 weeks gestation, wherein the amount of oncofetal fibronectin protein in said sample is determined using the monoclonal antibody FDC-6;

comparing the amount of oncofetal fibronectin protein in said sample to a threshold level of 200 ng/ml; and

classifying the amount of oncofetal fibronectin protein in said sample according to said threshold level, whereby classification of oncofetal fibronectin protein in said sample above said threshold identifies the likelihood of term delivery.