Claims for Patent: 6,348,316

Summary for Patent: 6,348,316

Title:	Genetic testing for determining the risk of pouchitis development
Abstract:	The present invention provides a method of determining a risk of pouchitis development following a surgical procedure where an internal pouch is created in a patient with ulcerative colitis. The method is practiced by determining in the patient the presence or absence of a pouchitis-associated allele linked to an interferon .gamma. receptor locus, where the presence of the pouchitis-associated allele indicates an increased risk of pouchitis development. The interferon .gamma. receptor locus to which the pouchitis-associated allele is linked can be, for example, an interferon .gamma. receptor 1 gene. A pouchitis-associated allele useful in the invention can be, for example, an allele located within the sixth intron of the interferon .gamma. receptor 1 gene, such as a FA1 microsatellite 171 allele.
Inventor(s):	Taylor; Kent D. (Santa Paula, CA), Yang; Huiyang (Cerritos, CA), Rotter; Jerome I. (Los Angeles, CA), Fleshner; Phillip R. (Beverly Hills, CA)
Assignee:	Cedars-Sinai Medical Center (Los Angeles, CA)
Application Number:	09/556,868
Patent Claims:	1. A method of determining a risk of pouchitis development following a surgical procedure whereby an internal pouch is created in a patient with ulcerative colitis, comprising determining the presence or absence in said patient of a pouchitis-associated allele linked to an interferon .gamma. receptor locus, wherein the presence of said pouchitis-associated allele indicates an increased risk of pouchitis development. 2. The method of claim 1, wherein said interferon .gamma. receptor locus is an interferon .gamma. receptor 1 gene (IFNGR1). 3. The method of claim 2, wherein said pouchitis-associated allele is within said IFNGR1. 4. The method of claim 3, wherein said pouchitis-associated allele is located within the sixth intron of said IFNGR1. 5. The method of claim 4, wherein said pouchitis-associated allele is an IFNGR1 FA1 microsatellite. 6. The method of claim 5, wherein said pouchitis-associated allele is a FA1 microsatellite 171 allele. 7. The method of claim 6, wherein said surgical procedure comprises ileal pouch anal anastomosis. 8. The method of claim 1, wherein said pouchitis is chronic pouchitis. 9. A method of determining a risk of chronic pouchitis development following ileal pouch anal anastomosis in a patient with ulcerative colitis, comprising determining the presence or absence in said patient of an interferon .gamma. receptor 1 FA1 microsatellite 171 allele, wherein the presence of said 171 allele indicates an increased risk of chronic pouchitis development. 10. The method of claim 1, wherein determining the presence or absence of said pouchitis-associated allele comprises enzymatic amplification of nucleic acid from said patient. 11. The method of claim 1, further comprising a step selected from the group consisting of electrophoretic analysis, restriction fragment length polymorphism analysis, sequence analysis, and any combination thereof. 12. The method of claim 1, wherein said pouchitis-associated allele is associated with chronic pouchitis with an odds ratio of at least 4 and a lower 95% confidence limit greater than 1. 13. The method of claim 6, wherein the presence or absence of a FA1 microsatellite 171 allele is determined, comprising: (a) obtaining material from said patient comprising nucleic acid comprising the FA1 microsatellite locus of interferon .gamma. receptor 1 gene; and (b) enzymatically amplifying said nucleic acid to produce an amplified fragment comprising said FA1 microsatellite locus, wherein the presence of the FA1 microsatellite 171 allele indicates an increased risk of pouchitis development. 14. The method of claim 13, further comprising: (c) electrophoresing said amplified fragment, thereby determining whether a FA1 microsatellite 171 allele is present. 15. The method of claim 1, wherein said pouchitis-associated allele is linked to an IFNGR1 FA1 microsatellite 171 allele.

Details for Patent 6,348,316

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	INTRON A	interferon alfa-2b	For Injection	103132	06/04/1986		2039-02-26
Merck Sharp & Dohme Corp.	INTRON A	interferon alfa-2b	For Injection	103132			2039-02-26
Merck Sharp & Dohme Corp.	INTRON A	interferon alfa-2b	Injection	103132			2039-02-26