Methods for disease detection

• US 6,586,177 B1
• Filed: 12/07/1999
• Issued: 07/01/2003
• Est. Priority Date: 09/08/1999
• 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): Fredman, Jeffrey
• Assistant Examiner(s): Chunduru, Suryaprabha
• Application Number:
  US09/455,950
• Time in Patent Office: 1,302 Days
• Field of Search: 435/6, 435/91.2, 536/24.3
• US Class Current: 435/6.16
• CPC Class Codes: C12Q 1/6881 for tissue or cell typing, e.g. human leukocyte antigen [HLA] probes
• 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

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 determining the presence of cancer or precancer, the method comprising the steps of:

determining an amount of nucleic acid, using an assay that detects both wild-type and mutant nucleic acid, in a patient sample comprising shed cells or cellular debris; and

identifying said patient as having cancer or precancer if said amount is greater than expected in a sample obtained from a healthy patient.

6. The method of claim 1, wherein said nucleic acid is selected from the group consisting of K-ras, p53, apc, dcc, tumor suppressor genes, and oncogenes.

7. The method of claim 1, wherein said patient sample is selected from the group consisting of sputum, pancreatic fluid, bile, lymph, blood, urine, cerebrospinal fluid, seminal fluid, saliva, breast nipple aspirate, and pus.

8. The method of claim 1, wherein said cancer is selected from the group consisting of lung cancer, esophageal cancer, prostate cancer, stomach cancer, pancreatic cancer, liver cancer, and lymphoma.

9. The method of claim 1, wherein said cancer is colon cancer.

10. The method of claim 1, wherein said patient sample is stool.

2. A method for screening a patient for the presence of cancer or precancer, the method comprising the steps of:

determining an amount of nucleic;

acid, using an assay that detects both wild-type and mutant nucleic acid, in a patient sample comprising shed cells or cellular debris; and

identifying a positive screen as a sample in which said amount exceeds a predetermined threshold amount.

11. The method of claim 2, wherein said patient sample is selected from the group consisting of sputum, pancreatic fluid, bile, lymph, blood, urine, cerebrospinal fluid, seminal fluid, saliva, breast nipple aspirate, and pus.

12. The method of claim 2, wherein said patient sample is stool.

3. A method for detecting presence of cancer or precancer, the method comprising steps of:

determining an amount of wild-type nucleic acid present in a patient sample comprising shed cells or cellular debris; and

detecting cancer or precancer in said patient if said amount is greater than a standard amount.

4. The method of claim 3 wherein said nucleic acid is a fragment having a molecular weight of at least 1.3 Kb.

5. The method of claim 3, wherein said cancer is selected from the group consisting of lung cancer, esophageal cancer, prostate cancer, stomach cancer, pancreatic cancer, liver cancer, and lymphoma.

13. The method of claim 3, wherein said cancer is colon cancer.

14. The method of claim 3, wherein said patient sample is selected from the group consisting of sputum, pancreatic fluid, bile, lymph, blood, urine, cerebrospinal fluid, seminal fluid, saliva, breast nipple aspirate, and pus.

15. The method of claim 3, wherein said patient sample is stool.