Claims for Patent: 6,790,618

Summary for Patent: 6,790,618

Title:	Method for determining the susceptibility of a NIDDM patent toward sulfonylurea therapy
Abstract:	A method is provided for determining the susceptibility of a NIDDM patient towards sulfonylurea therapy by obtaining a sample from a NIDDM patient where the sample includes nucleic acid molecules containing a fragment of the SUR1 gene comprising the nucleotide in position -3 of exon 16 and detecting the presence or absence of the -3 t allele in position -3 of exon 6 whereby the presence of at least one -3 t allele identifies a NIDDM patient with a high susceptibility towards sulfonylurea therapy.
Inventor(s):	Amouyel; Philippe (Marco-En-Baroeul, FR), Helbecque; Nicole (Marco-En-Baroeul, FR), Meirhaeghe; Aline (Lille, FR)
Assignee:	Institut Pasteur de Lille (Lille, FR) Institut National de la Sante et de la Recherche Medicale (Inserm) (Paris, FR)
Application Number:	09/913,731
Patent Claims:	1. A method for determining the susceptibility of a NIDDM patient toward sulfonylurea therapy comprising: a) obtaining a sample from a NIDDM patient, said sample comprising nucleic acid molecules containing the fragment of the SUR1 gene comprising the nucleotide in position -3 of exon 16, b) detecting the presence or the absence of the -3t allele of exon 16, whereby the presence of at least one -3t allele identifies a NIDDM patient with a higher susceptibility toward sufonylurea therapy relative to another NIDDM patient receiving a sufonylurea therapy without the at least one -3t allele. 2. The method according to claim 1, further comprising prior to step b) the step of amplifying said nucleic acid molecules using amplification primers that selectively anneal to and amplify a portion of said gene comprising the nucleotide in position -3 of exon 16. 3. The method according to claim 1, further comprising prior to step b) the step of amplifying said nucleic acid molecules using as amplification primers, the nucleic acid fragments of SEQ ID N.degree. 2 and SEQ ID n.degree. 3, that selectively anneal to and amplify a portion of said gene comprising the nucleotide in position -3 of exon 16. 4. The method of claim 1, wherein said detecting step b) comprises sequencing all or part of the sequence of intron 15 comprising said -3 nucleotide. 5. The method of claim 1, wherein said detecting step b) comprises contacting the nucleic acid molecules with a nucleic acid probe that selectively hybridizes to a portion of intron 15 of SUR1 gene containing nucleotide -3 as shown in SEQ ID n.degree. 1 under hybridization conditions. 6. The method of claim 1, wherein the detecting step b) comprises performing a restriction endonuclease digestion of said nucleic acid molecules thereby yielding a nucleic acid digest and contacting the digest with a nucleic acid probe that selectively hybridizes to a portion of intron 15 of said SUR 1 gene containing nucleotide -3 as showed in SEQ ID n.degree. 1. 7. The method of claim 1, wherein said detecting step b) comprises obtaining a first gene fragment comprising an initially unidentified nucleotide -3 of exon 16 isolated from the sample from the NIDDM patient and a second gene fragment comprising nucleotide -3c of exon 16, said second fragment corresponding to said first fragment but with a known -3c nucleotide, forming single-stranded DNA from said SUR1 gene fragment and from said second SUR1 gene fragment, electrophoresing said single-stranded DNAs on a denaturating polyacrylamide gel, comparing the mobility of said single-stranded DNAs on said gel to determine if said single-stranded DNA from said first SUR1 gene fragment is shifted relative to said second SUR1 gene fragment, and optionally sequencing said single-stranded DNA from said first SUR1 gene fragment having a shift in mobility. 8. The method of claim 1 wherein said detecting step b) comprises obtaining a first gene fragment comprising an initially unidentified nucleotide -3 of exon 16, isolated from the sample from the NIDDM patient and a second fragment comprising nucleotide -3t of exon 16, said second fragment corresponding to said first fragment but with a known -3t nucleotide, forming single-stranded DNA from said SUR1 gene fragment and from said second SUR1 gene fragment, electrophoresing said single-stranded DNAs on a denaturating polyacrylamide gel, comparing the mobility of said single-stranded DNAs on said gel to determine if said single-stranded DNA from said first SUR1 gene fragment has the same mobility as the said second SUR1 gene fragment, and optionally sequencing said single-stranded DNA from said first SUR1 gene fragment. 9. The method of claim 1 wherein said detecting step b) comprises amplifying all or part of a SUR1 gene in said sample using a primer specific for allele -3t and detecting the presence of an amplified product, whereby the presence of said product indicates the presence of said allele in the sample.

Details for Patent 6,790,618

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		2019-02-19
Merck Sharp & Dohme Corp.	INTRON A	interferon alfa-2b	For Injection	103132			2019-02-19
Merck Sharp & Dohme Corp.	INTRON A	interferon alfa-2b	Injection	103132			2019-02-19