Diagnosis of carcinomas

• US 9,090,712 B2
• Filed: 08/06/2009
• Issued: 07/28/2015
• Est. Priority Date: 08/29/2001
• Status: Active Grant

• Current Assignee: Pacific Northwest Research Institute
• Original Assignee: Pacific Northwest Research Institute
• Inventors: Hellstrom, Ingegerd, Ledbetter, Jeffrey A., Hayden-Ledbetter, Martha
• Primary Examiner(s): CANELLA, KAREN A
• Application Number:
  US12/536,975
• Publication Number:
  US 20100047818A1
• Time in Patent Office: 2,182 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61K 2039/505 comprising antibodies
• CPC Class Codes: A61P 1/18 for pancreatic disorders, e.g. pancreatic enzymes
• CPC Class Codes: A61P 15/00 Drugs for genital or sexual disorders for disorders of sex hormones A61P5/24; Contraceptives
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 35/02 specific for leukemia
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: C07K 14/811 Serine protease (E.C. 3.4.21) inhibitors
• CPC Class Codes: C07K 16/18 against material from animals or humans
• CPC Class Codes: C07K 16/30 from tumour cells
• CPC Class Codes: C07K 16/3069 Reproductive system, e.g. ovaria, uterus, testes, prostate
• CPC Class Codes: C07K 16/40 against enzymes
• CPC Class Codes: C07K 2319/00 Fusion polypeptide
• CPC Class Codes: C07K 2319/30 Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
• CPC Class Codes: G01N 2333/705 Assays involving receptors, cell surface antigens or cell surface determinants
• CPC Class Codes: G01N 33/57449 of ovaries
• CPC Class Codes: G01N 33/57488 involving compounds identifable in body fluids

Abstract

The invention is directed to compositions and methods for the detection of a malignant condition, and relates to the discovery of soluble and cell surface forms of HE4a polypeptides, including HE4a that is overexpressed in ovarian carcinomas. In particular the invention provides a nucleic acid sequence encoding HE4a, and also provides a method of screening for the presence of a malignant condition in a subject by detecting reactivity of an antibody specific for a HE4a polypeptide with a molecule naturally occurring in soluble and/or cell surface form in a sample from such a subject, and by hybridization screening using an HE4a nucleotide sequence, as well as other related advantages.

Claims

1. A fusion protein comprising an HE4a polypeptide, fused to an immunoglobulin domain polypeptide portion, wherein the fusion protein comprises the amino acid sequence of SEQ ID NO:

7.

2. The fusion protein of claim 1, wherein the fusion protein is glycosylated.