FDA Clears the AmpliChip Cytochrome P450 Genotyping Test.........

[Guest guest]

..

FDA News

 

FOR IMMEDIATE RELEASE

P04-111

December 23, 2004

Media Inquiries: 301-827-6242

Consumer Inquiries: 888-INFO-FDA

 

FDA Clears First of Kind Genetic Lab Test "

http://www.fda.gov/bbs/topics/news/2004/new01149.html

 

The Food and Drug Administration (FDA) today cleared for marketing the

first laboratory test system that will allow physicians to consider

unique genetic information from patients in selecting medications and

doses of medications for a wide variety of common conditions such as

cardiac disease, psychiatric disease, and cancer.

 

" Physicians can use the genetic information from this test to prevent

harmful drug interactions and to assure drugs are used optimally, which

in some cases will enable patients to avoid less effective or potentially

harmful treatment choices, " said Dr. Lester M. Crawford, Acting FDA

Commissioner.

 

The new test is the AmpliChip Cytochrome P450 Genotyping Test made by

Roche Molecular Systems, Inc., of Pleasanton, Calif. It was cleared for

use with the Affymetrix GeneChip Microarray Instrumentation System,

manufactured by Affymetrix, Inc., of Santa Clara, Calif.

 

The new test is the first DNA microarray test to be cleared by the FDA

and its clearance paves the way for similar microarray-based diagnostic

tests to be developed in the future. A microarray is similar to a

computer microchip, but instead of tiny circuits, the chip contains

millions of tiny DNA molecules. The test is performed using DNA that is

extracted from a patient's blood. A person's DNA sequence is determined

based on the sequence of the probe molecule to which the DNA is most

similar.

 

The new test analyzes one of the genes from a family of genes called

cytochrome P450 genes, which are active in the liver to break down

certain drugs and other compounds. Variations in this gene can cause a

patient to metabolize certain drugs more quickly or more slowly than

average, or, in some cases, not at all. The specific enzyme from this

family that is analyzed by this test, called cytochrome P4502D6, plays an

important role in the body's ability to metabolize some commonly

prescribed drugs including antidepressants, anti-psychotics,

beta-blockers, and some chemotherapy drugs.

 

The test is not intended to be a stand-alone tool to determine optimum

drug dosage, but should be used along with clinical evaluation and other

tools to determine the best treatment options for patients.

 

FDA cleared the test and the scanner based on results of a study

conducted by the manufacturers of hundreds of DNA samples as well as on a

broad range of supporting peer-reviewed literature.

 

####

 

Get free weekly updates about FDA press releases, recalls, speeches,

testimony and more.

 

Media Contacts | FDA News Page

 

FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | Privacy |

Accessibility

 

FDA Website Management Staff