PGNX in RUM- know amplichip CYP450?

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dear friends, can we discuss the rational way for drug use with the help of PGNX. yes its already actively utilized and that to with the approval from FDA. please go through the abstract below. You can get to the page directly via following link http://www.ingentaconnect.com/content/adis/inn/2005/00000003/00000011/art00002 Application of AmpliChip™ CYP450 Author: Adis International Limited, Source: Pharmaceutical & Diagnostic Innovation, Volume 3, Number 11, 2005 , pp. 3-7(5) Publisher: Adis International ·

< previous article · | · next article > · | · view table of contents Key: - Free Content - New Content - Subscribed Content - Free Trial Content Abstract: Cytochrome P450 (CYP) enzymes play vital roles in the metabolism of a large number of pharmaceuticals. Two CYP enzymes of particular clinical relevance, CYP2D6 and CYP2C19, are involved in the metabolism of approximately 25% of all medical drugs. Polymorphisms in the genes encoding these enzymes lead to inter-individual variation in response to drugs that can result in adverse effects or lack of therapeutic effect with standard dosages. Given these important clinical consequences, a variety of technologies have been investigated for identifying CYP variants, the most advanced of which is the AmpliChip™

CYP450 test from Roche Diagnostics.AmpliChip CYP450 enables genotype-based detection of clinically important polymorphisms in CYP2D6 and CYP2C19. In late 2004, the technology became the first DNA microarray to be approved by the US FDA for medical testing. The AmpliChip CYP450 test enables physicians to ascertain patients' CYP2D6 and/or CYP2C19 status to help guide choice of medication and dosage. Determining CYP2D6 genotype is of particular relevance to psychiatrists, as many of the drugs metabolized by this enzyme are antipsychotics or antidepressants. Clinical oncology is another obvious area for application, with many anticancer agents metabolized by CYP2D6 and CYP2C19.The approval of AmpliChip CYP450 paves the way for similar microarray-based diagnostic tests to be commercialized in the future. However, there is much uncertainty over the use and impact of such pharmacogenomic testing technologies in real-world patient management and it appears that their integration

into the current standard of care will be challenging. Obvious barriers to such applications include economic factors and lack of physician education. The use of pharmacogenomic testing technologies in drug development is also uncertain. However, the FDA recently defined CYP2D6 as a `known valid biomarker'; as a result, a company wishing to submit an investigational new drug application for clinical trials must include data relating to their drug candidate's effect on CYP2D6. This is likely to boost application of AmpliChip CYP450 in drug development. Keywords: Diagnostic tests; Diagnostics; Pharmacogenomics Document Type: Research article The full text article is available for purchase $54.95 plus tax regards, Dr Kiran Chaudhari Lecturer, Pharmacology GMC, Nagpur

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