Methods for disease detection

• US 6,919,174 B1
• Filed: 02/28/2000
• Issued: 07/19/2005
• Est. Priority Date: 12/07/1999
• Status: Expired due to Term

• Current Assignee: Esoterix Genetic Laboratories LLC (Laboratory Corporation Of America Holdings)
• Original Assignee: Exact Sciences Corporation
• Inventors: Shuber, Anthony P.
• Primary Examiner(s): Myers, Carla J.
• Assistant Examiner(s): MERKLING, SALLY ANNE
• Application Number:
  US09/514,865
• Time in Patent Office: 1,968 Days
• Field of Search: 435/6, 435/7.23, 435/91.1, 435/91.2, 435/183, 536/23.1, 536/24.3, 536/24.33, 536/25.41, 536/25.3
• US Class Current: 435/6.16
• CPC Class Codes: C12Q 1/6886 for cancer immunoassay for cancer G01N33/574
• CPC Class Codes: C12Q 2600/156 Polymorphic or mutational markers

Abstract

The present invention provides methods for detecting disease by analysis of a patient sample to determine the integrity of nucleic acids in the sample.

Claims

1. A method for screening for cancer or adenoma in a patient, the method comprising the steps of:

determining an amount of nucleic acid greater than about 200 bp in length, using an assay that detects said nucleic acid regardless of whether said nucleic acid is mutant or wild-type, present in a patient sample comprising shed cells or cellular debris; and

identifying said patient as having cancer or adenoma if said amount is greater than an amount of nucleic acid expected to be present in a sample obtained from a patient who does not have cancer or adenoma.

2. The method of claim 1, wherein said cancer or adenoma is selected from the group consisting of colon cancer, lung cancer, esophageal cancer, stomach cancer, pancreatic cancer, cancer of the bile duct, and cancer of the duodenum.

3. The method of claim 1, wherein the nucleic acid is at least 1.3 Kb in length.

4. The method of claim 1, wherein said nucleic acid comprises human nucleic acid.