Reagents and methods useful for detecting diseases of the breast

• US 7,479,537 B2
• Filed: 05/11/2005
• Issued: 01/20/2009
• Est. Priority Date: 10/31/1996
• Status: Expired due to Fees

• Current Assignee: Abbott Laboratories Incorporated
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Klass, Michael R., Granados, Edward N., Roberts-Rapp, Lisa, Friedman, Paula N., Kratochvil, Jon D., Stroupe, Stephen D., Billing-Medel, Patricia A., Hodges, Steven C., Russell, John C., Cohen, Maurice, Colpitts, Tracey L., Gordon, Julian
• Primary Examiner(s): Helms; Larry R.
• Assistant Examiner(s): Natarajan; Meera
• Application Number:
  US11/126,456
• Publication Number:
  US 20050214848A1
• Time in Patent Office: 1,350 Days
• Field of Search: None
• US Class Current: 530/324
• CPC Class Codes: A61K 38/00 Medicinal preparations containing peptides peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00
• CPC Class Codes: C07K 14/47 from mammals
• CPC Class Codes: C07K 16/3015 Breast
• CPC Class Codes: C12Q 1/6886 for cancer immunoassay for cancer G01N33/574
• CPC Class Codes: C12Q 2600/136 Screening for pharmacological compounds
• CPC Class Codes: C12Q 2600/158 Expression markers
• CPC Class Codes: G01N 2500/00 Screening for compounds of potential therapeutic value
• CPC Class Codes: G01N 33/57415 of breast

Abstract

A set of contiguous and partially overlapping RNA sequences and polypeptides encoded thereby, designated as BS106 and transcribed from breast tissue is described. These sequences are useful for the detecting, diagnosing, staging, monitoring, prognosticating, preventing or treating, or determining the predisposition of an individual to diseases and conditions of the breast such as breast cancer. Also provided are antibodies which specifically bind to BS106-encoded polypeptide or protein, and agonists or inhibitors which prevent action of the tissue-specific BS106 polypeptide, which molecules are useful for the therapeutic treatment of breast diseases, tumors or metastases.

Claims

1. An isolated polypeptide having a sequence consisting of an amino acid sequence selected from the group consisting of SEQUENCE ID NO:

16, SEQUENCE ID NO;

17, SEQUENCE ID NO;

18, SEQUENCE ID NO;

19, SEQUENCE ID NO;

20, and fragments of SEQUENCE ID NOS;

16-20, wherein said fragments consist of a sequence having a length of 15 to 20 amino acids.

2. The polypeptide of claim 1, wherein said polypeptide is produced by recombinant techniques.

3. The polypeptide of claim 1, wherein said polypeptide is produced by synthetic techniques.

4. An assay kit for determining the presence of an antigen or antibody in a test sample, comprising a container containing a polypeptide having a sequence consisting of an amino acid sequence selected from the group consisting of SEQUENCE ID NO:

16, SEQUENCE ID NO;

17, SEQUENCE ID NO;

18, SEQUENCE ID NO;

19, SEQUENCE ID NO;

20 and fragments thereof, wherein said fragments consist of a sequence having a length of 15 to 20 amino acids.

5. The assay kit of claim 4, wherein said polypeptide is attached to a solid phase.

10. The assay kit of claim 4 further comprising a container with tools useful for collection of said sample, wherein the tools are selected from the group consisting of lancets, absorbent paper, cloth, swabs and cups.

6. A method for producing a polypeptide comprising at least one epitope, said method comprising incubating host cells that have been transfected with an expression vector containing a polynucleotide sequence encoding a polypeptide, wherein said polypeptide comprises an amino acid sequence having a sequence consisting of an amino acid sequence selected from the group consisting of SEQUENCE ID NO:

16, SEQUENCE ID NO;

17, SEQUENCE ID NO;

18, SEQUENCE ID NO;

19, SEQUENCE ID NO;

20, and fragments thereof, wherein said fragments consist of a sequence having a length of 15 to 20 amino acids.

7. A method for detecting the presence of antibodies specific for an antigen in a test sample suspected of containing such antibodies, said method comprising:

(a) contacting the test sample with a polypeptide derived from an amino acid sequence or fragment thereof having an amino acid sequence selected from the group consisting of SEQUENCE ID NO;

16, SEQUENCE ID NO;

17, SEQUENCE ID NO;

18, SEQUENCE ID NO;

19, SEQUENCE ID NO;

20, and fragments thereof, and further wherein said contacting is carried out for a time and under conditions sufficient to allow antigen/antibody complexes to form; and

(b) detecting said complexes, and even still further wherein said fragments consist of a sequence having a length of 15 to 20 amino acids.

8. The method of claim 7, wherein said polypeptide is attached to a solid phase.

9. A composition of matter comprising an isolated polypeptide, wherein said polypeptide has an amino acid sequence selected from the group consisting of SEQUENCE ID NO:

16, SEQUENCE ID NO;

17, SEQUENCE ID NO;

18 SEQUENCE ID NO;

19, SEQUENCE ID NO;

20, and fragments of SEQUENCE ID NOS;

16-20, wherein said fragments consist of a sequence having a length of 15 to 20 amino acids.