US 8,076,093 B2 · Monoclonal antibodies and methods for their use in the detection of cervical disease

Abstract

Compositions and methods for diagnosing high-grade cervical disease in a patient sample are provided. The compositions include novel monoclonal antibodies, and variants and fragments thereof, that specifically bind to MCM2. Monoclonal antibodies having the binding characteristics of an MCM2 antibody of the invention are further provided. Hybridoma cell lines that produce an MCM2 monoclonal antibody of the invention are also disclosed herein. The compositions find use in practicing methods for diagnosing high-grade cervical disease comprising detecting overexpression of MCM2 in a cervical sample from a patient. Kits for practicing the methods of the invention are further provided. Polypeptides comprising the amino acid sequence for an MCM2 epitope and methods of using these polypeptides in the production of antibodies are also encompassed by the present invention.

Claims14

Dependent claims

A method for diagnosing high-grade cervical disease in a patient, the method comprising:

a) obtaining a cervical sample from the patient;
b) contacting the sample with at least one monoclonal antibody that specifically binds to MCM2 and is selected from the group consisting of:
(i) the monoclonal antibody produced by the hybridoma cell line 27C5.6, deposited with the ATCC as Patent Deposit No. PTA-6668;
(ii) the monoclonal antibody produced by the hybridoma cell line 26H6.19, deposited with the ATCC as Patent Deposit No. PTA-6667;
(iii) a monoclonal antibody that binds to the amino acid sequence set forth in SEQ ID NO:3;
(iv) a monoclonal antibody that binds to the amino acid sequence of SEQ ID NO:14;
and
(v) an antigen binding fragment of a monoclonal antibody of (i)-(iv), wherein the fragment retains the capability of specifically binding to MCM2;
and,
c) detecting binding of the antibody to MCM2 in the cervical sample.

7 more elements

Dependencies are inferred from the claim text.

Facts

Application

12/545,738Filed 21 Aug 2009 · division

Priority

27 Apr 2005

Published

US 2009/0317826 A124 Dec 2009

Granted

13 Dec 2011

Term ends

Not estimatedThe source records don’t support an estimate.

Classification6 codes

G01N 33/5755
For cancer: of the uterine cervix, uterine corpus or endometrium
C07K 14/4738
Not used: cell cycle regulated proteins, e.g. cyclin, CDC, INK-CCR
C07K 16/3069
From tumour cells: reproductive system, e.g. ovaria, uterus, testes, prostate
C07K 2317/34
Characterized by aspects of specificity or valency: identification of a linear epitope shorter than 20 amino acid residues or of a conformational…

Family

Application60/675,305Us provisional application · filed 27 Apr 2005

Application60/718,082Us provisional application · filed 16 Sep 2005

Application11/410,272Parent of this division · filed 24 Apr 2006

US 2009/0317826 A1Pre-grant publication · published 24 Dec 2009

US 7,595,380 B2Parent of this division

US 2006/0252106 A1Published application

US 8,076,093 B2This patent

From the US filing history. Foreign family members aren’t listed.

Monoclonal antibodies and methods for their use in the detection of cervical disease

Life of this patent

Monoclonal antibodies and methods for their use in the detection of cervical disease

Life of this patent

Abstract

Claims14