Methods for Detecting Nucleic Acids Indicative of Cancer

• US 20100173320A1
• Filed: 03/22/2010
• Published: 07/08/2010
• Est. Priority Date: 04/09/1999
• Status: Abandoned Application

• Current Assignee: Exact Sciences Corporation
• Original Assignee: Genzyme Corporation (Sanofi )
• Inventors: SHUBER, ANTHONY P.
• Application Number:
  US12/729,051
• Publication Number:
  US 20100173320A1
• Time in Patent Office: Days
• US Class Current: 435/6
• CPC Class Codes: C12Q 1/6886 for cancer immunoassay for cancer G01N33/574
• CPC Class Codes: G01N 33/57419 of colon
• CPC Class Codes: G01N 33/57473 involving carcinoembryonic antigen, i.e. CEA

Abstract

The invention provides methods for screening tissue or body fluid samples for nucleic acid indicia of cancer or precancer.

Claims

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

detecting in a patient tissue or body fluid sample comprising exfoliated cells and cellular debris, nucleic acid fragments that are greater than 200 base pairs in length;

the presence of said fragments being a positive screen for cancer or precancer.

2. The method of claim 1, wherein said detecting step comprises conducting an amplification reaction designed to amplify only nucleic acids in said sample that are greater than 200 base pairs in length.

3. The method of claim 1, wherein said sample is selected from the group consisting of stool, pus, and urine.

4. The method of claim 1, further comprising the step of enriching said sample for human DNA.

5. The method of claim 1, further comprising the step of isolating human DNA from said sample.

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

determining in a patient tissue or body fluid sample a first amount of nucleic acid fragments greater than 200 base pairs in length;

determining in said sample a second amount of nucleic acid fragments less than about 200 base pairs in length;

determining a ratio between said first amount and said second amount; and

identifying a positive screen if said ratios exceeds a threshold ratio for patients who do not have cancer or precancer.

7. A method for screening a patient for cancer or precancer, the method comprising the step of

detecting in a patient tissue or body fluid sample comprising exfoliated cells a nucleic acid fragment of a length that is not expected to be present in said sample in a healthy patient;

the presence of said fragment being a positive screen.