FRAMINGHAM (09/24/2003) - Reinforcing its position as a pharmacogenomics pioneer, diagnostic giant Roche Diagnostic Corp. launched in June a P450 chip measuring DNA markers for predicting patient responses to many common drugs.
The AmpliChip CYP450 test is based on the Affymetrix Inc. GeneChip DNA analysis platform. The chip detects variations in DNA that are known to affect genes controlling the body's mechanisms for processing drugs, and it is the first chip using Affymetrix technology that meets federal standards for clinical use. The test can be run only in reference laboratories, which must meet specific certification standards. In the future, though, it could become easier to use in a variety of settings.
The FDA, however, is questioning Roche's classification of the genetic test, which allowed it to circumvent a regulatory review before going to market. At press time, the FDA and Roche were still in discussions.
It is well known that some people are overly sensitive, or unresponsive, to certain drugs because of genetic variations in the CYP450 family of genes. Doctors have not routinely tested patients' P450 genes, however, because they did not believe a "reproducible and reliable" test existed, says Thomas Metcalfe, senior vice president of genomics and strategic business development at Roche Molecular Diagnostics. It is also complicated to interpret information about P450 genes many variations exist in many genes.
Educating doctors, Metcalfe says, is a major challenge when introducing pharmacogenomic products such as the P450 chip.
Eventually, the chip could become standard preventive care because it provides information on patients' potential responses to about a quarter of the drugs already on the market.
Vendor: Roche Diagnostic Corp.
Product Name: AmpliChip CYP450
For more information: +41 61 688 3079; or www.roche-diagnostics.com