Detection of oncofetal fibronectin for selection of concepti

• US 20060024757A1
• Filed: 07/29/2005
• Published: 02/02/2006
• Est. Priority Date: 07/30/2004
• Status: Abandoned Application

• Current Assignee: Cytyc Corporation (Hologic Incorporated)
• Original Assignee: Cytyc Corporation (Hologic Incorporated)
• Inventors: Hussa, Robert, Shorter, Simon
• Application Number:
  US11/193,561
• Publication Number:
  US 20060024757A1
• Time in Patent Office: Days
• US Class Current: 435/7.200
• 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 fibronection for selection of concepti are provided.

Claims

1. A method for selecting concepti for implantation, comprising:

testing one or more conceptus samples to detect an oncofetal fibronectin indicating molecule; and

selecting a conceptus or concepti for implantation that yielded an oncofetal fibronectin positive sample.

2. The method of claim 1, wherein the oncofetal fibronectin indicating molecule comprises a fibronectin III connecting segment (IIICS), an EDA or EDB segment or an autoantibody that specifically binds to IIICS, EDA or EDB.

3. The method of claim 1, wherein an amount of oncofetal fibronectin indicating molecule in the sample equal to or greater than a predetermined threshold level identifies the sample as oncofetal fibronectin positive.

4. The method of claim 3, wherein the threshold level is a level predetermined to indicate that the conceptus will implant.

5. The method of claim 3, wherein samples from two or more concepti are assayed, and the conceptus that yields a sample containing a higher level of oncofetal fibronectin indicating molecule is selected for implantation.

6. The method of claim 1, further comprising assessing the rate of increase of oncofetal fibronectin, wherein the rate is assessed by:

testing a second conceptus sample from the same conceptus to detect an oncofetal fibronectin indicating molecule, wherein a conceptus for which the second sample contains more oncofetal fibronectin indicating molecule than the first sample is suitable for implantation.

7. The method of claim 6, wherein two or more samples from each of two or more concepti are assayed and the conceptus that exhibits the highest rate of increase of oncofetal fibronectin is selected for implantation.

8. The method of claim 1, wherein the conceptus sample is selected from among conceptus extract, sample from outside of the conceptus, culture fluid bathing the conceptus and an extract of a cell from the conceptus.

9. The method of claim 1, wherein the sample is treated with a reagent and/or fractionated prior to the step of testing for an oncofetal fibronectin indicating molecule in a conceptus sample.

11. The method of claim 1, further comprising determining an additional maternal or conceptus marker that is predetermined to be marker for successful implantation.

12. The method of claim 11, wherein the additional marker is detected in a conceptus sample or is determined by visual inspection of the conceptus or is detected in a maternal sample.

13. The method of claim 12, wherein the additional markers are selected from among genetic composition of the conceptus, gene expression of the conceptus and morphology of the conceptus.

14. The method of claim 13, wherein one additional marker is morphology of the conceptus, and the morphology of the conceptus is graded according to factors selected from among cell number, degree of fragmentation, cell regularity, symmetry, pronuclear morphology, follicle size, follicular fluid volume, multi-nucleation, presence of vacuoles, granularity, and combinations thereof.

10. The method of 8, wherein a sample from outside the conceptus is an extract of culture medium in which a single conceptus has been cultured.