Patent: 5,552,283

Summary for Patent: 5,552,283

Title:	Method, reagents and kit for diagnosis and targeted screening for P53 mutations
Abstract:	Rapid and cost effective diagnosis of p53 mutations of a sample of patients is achieved by employing a selected plurality of diagnostic tools, in a hierarchy of increasing accuracy and cost per tool, in which each tool detects essentially no false positives. Diagnostic tests that may be included among the plurality of tests selected include, in order of increasing accuracy and cost: (a) immunoassays, (b) analysis of DNA from a patient sample by quantitative amplification of p53 exons using amplification primers complementary to intron regions flanking each exon and examination of the length or quantity of each amplified fragment for nucleotide insertions or deletions relative to the normal p53 gene. Preferably, the amplification primers are multiplexed so that more than one DNA fragment is amplified in a single vessel, using sets of primers which provide gene fragments of distinctive lengths when used to amplify a normal p53 gene; and (c) analysis of DNA from a patient sample by DNA sequencing of the p53 gene beginning with the sequencing of those regions most likely to harbor point mutations, and proceeding to sequence regions less likely to harbor point mutations.
Inventor(s):	Diamandis; Eleftherios (Toronto, CA), Dunn; James M. (Scarborough, CA), Stevens; John K. (Toronto, CA)
Assignee:	Visible Genetics Inc. (Toronto, CA)
Application Number:	08/388,381
Patent Claims:	see list of patent claims

Details for Patent 5,552,283

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		2014-07-08
Merck Sharp & Dohme Corp.	INTRON A	interferon alfa-2b	For Injection	103132			2014-07-08
Merck Sharp & Dohme Corp.	INTRON A	interferon alfa-2b	Injection	103132			2014-07-08