IP Library Granted Patent US 9,441,275
Granted Patent B2
US 9,441,275 · App. 13/259,514 · Granted Sep 13, 2016

Polymorphism in CYP3A4 gene affecting drug metabolizing and uses thereof

Inventors: Wolfgang Sadee (Upper Arlington, OH); Danxin Wang (Columbus, OH)
Assignee: Ohio State Innovation Foundation
C12Q1/6883G01N33/5038C12Q2600/106C12Q2600/16C12Q2600/172G01N2800/044G01N2800/52
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Quick Facts
Patent No.
US 9,441,275
App. No.
13/259,514
Granted
Sep 13, 2016
Kind
B2
Abstract

A method for predicting a subject's risk factors for CYP3A4-related disorders includes detecting the allelic status of a SNP in a nucleic acid sample of the subject.

Claims (20)

1. A method of administering a statin dose to a human, comprising:

obtaining a nucleic acid-containing test sample from a human, wherein the human is in need of statin therapy;

conducting at least one genotyping assay of the sample so as to obtain at least the genotype data at position rs35599367 of CYP3A4 in the sample, wherein the at least one genotyping assay comprises hybridizing a tagged primer to DNA in the nucleic acid-containing test sample, amplifying the hybridized DNA and detecting the tagged primer;

detecting a T allele at position rs35599367 of CYP3A4; and

administering a statin dose to the human comprising a TT or TC genotype at position rs35599367 of CYP3A4 of less than 20 mg per day wherein the statin administered is a statin that depends on CYP3A4 for elimination.

2. The method of claim 1 , which further comprises a step of predicting cholesterol control outcome.

3. The method of claim 1 , which further comprises identifying at least one additional biomarker of statin metabolism.

4. The method of claim 1 , wherein said nucleic acid is a nucleic acid extract from a biological sample from said human.

5. The method of claim 4 , in which said sample is blood, saliva, or buccal cells.

6. A method of administering a statin dose to a human, comprising:

obtaining a nucleic acid-containing test sample from a human, wherein the human is in need of statin therapy;

conducting at least one genotyping assay of the sample so as to obtain at least the genotype data at position rs35599367 of CYP3A4 in the sample, wherein the at least one genotyping assay comprises hybridizing a tagged primer to DNA in the nucleic acid-containing test sample, amplifying the hybridized DNA, and detecting the tagged primer;

detecting a C allele at position rs35599367 of CYP3A4; and

administering a statin dose to the human comprising a CC genotype at position rs35599367 of CYP3A4 of more than 40 mg per day, wherein the statin administered is a statin that depends on CYP3A4 for elimination.

7. The method of claim 6 , which further comprises a step of predicting cholesterol control outcome.

8. The method of claim 6 , which further comprises identifying at least one additional biomarker of statin metabolism.

9. The method of claim 6 , wherein said nucleic acid is a nucleic acid extract from a biological sample from said human.

10. The method of claim 9 , in which said sample is blood, saliva, or buccal cells.

11. The method of claim 1 , wherein one or more statins are given, and the one or more statins is selected from the group consisting of atorvastatin, lovastatin, and simvastatin.

12. The method of claim 6 , wherein one or more statins are given, and the one or more statins is selected from the group consisting of atorvastatin, lovastatin, and simvastatin.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 21, 2015
From: THE OHIO STATE UNIVERSITY RESEARCH FOUNDATION
To: OHIO STATE INNOVATION FOUNDATION
Reel/Frame 035688/0552 →
CONFIRMATORY LICENSE Recorded Nov 15, 2011
From: THE OHIO STATE UNIVERSITY
To: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
Reel/Frame 027232/0652 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 7, 2011
From: SADEE, WOLFGANG; WANG, DANXIN
To: THE OHIO STATE UNIVERSITY RESEARCH FOUNDATION
Reel/Frame 027033/0108 →
Continuity (2)
Provisional Application 61163555 · Mar 26, 2009
Related Publication 20120040347A1 · Feb 16, 2012