Genetic variations in the genes that determine your metabolic enzyme activity can lead to differences in how your drugs work in your body.

• The majority of people are extensive metabolizers who can be administered drugs following "standard" dosing practices
• Some people are intermediate metabolizers, meaning that they metabolize drugs at a slower-than-normal rate—somewhere between the rates of poor and extensive metabolizers. Multiple drug therapy regimens can turn these people into poor metabolizers because drugs can also inhibit their metabolic enzyme activity
• Some people are poor metabolizers with a "deficiency" in drug metabolism, which could lead to life-threatening drug accumulation and severe adverse reactions
• Some people are ultrarapid metabolizers who break down drugs at faster rates than extensive metabolizers. These people may experience either no effect or less-than-expected effectiveness from their drug therapy

Depending on what category you fit into, you may metabolize too slowly or too quickly. The AmpliChip^® CYP450 Test can be performed using a simple blood test; analysis of the data can be achieved in 8 hours, and test results can be received by your doctor within several days from receipt of the sample at the lab. These results, along with clinical evaluations and other lab tests, can be used to help your doctor create a treatment that is "just right" for your metabolic profile.

For certain drugs called pro-drugs, the opposite phenomenon occurs; ultrarapid metabolizers may suffer adverse events and poor metabolizers may not respond.

Find out about the How the AmpliChip^® CYP450 Test Works, or get advice on Talking to Your Doctor about testing.

Making Therapy Right for Every Patient

We are all different, so why are our medications based on a "one-size-fits-all" approach?

These two well-known tragic cases involved antidepressants:

• A 9-year-old died due to fluoxetine toxicity. Genetic tests confirmed that he had a gene defect at the CYP2D6 locus, which made him a poor metabolizer of fluoxetine (Sallee FR et al. J Child Adolesc Psychopharmacol. 2000;10:27-34)
• A woman spent 10 years trying different treatments for depression and experiencing intolerable side effects from all medications until she was switched to a drug that did not need the CYP2D6 enzyme to function (Lerner B et al. J Genet Couns. 2004;13:259-266)

In both cases, patients were poor metabolizers of CYP2D6. These cases are unique in their severity, but many psychiatric medications can be difficult to dose because of genetic variations in the genes that influence metabolism.

The first FDA-cleared microarray for in vitro diagnostic use in the United States, the AmpliChip^® CYP450 Test detects variations in CYP2D6 and CYP2C19, two cytochrome P450 genes that play major roles in metabolizing many widely prescribed drugs, including psychotropic medications. The AmpliChip^® CYP450 Test identifies patient genotype and provides predicted phenotype—poor, intermediate, extensive, or ultrarapid metabolizer—and may be used as an aid to clinicians in determining dosing for therapeutics metabolized by the CYP2D6 or CYP2C19 genes. Genotyping may improve patient outcomes by reducing adverse drug reactions and improving drug efficacy.

Get the most accurate information available on the AmpliChip^® CYP450 Test with our Press Kit, learn about the Technology Behind the AmpliChip^® CYP450 Test or explore our scientific backgrounders.

Feel free to Contact Us if you have any questions or would like more information.

The More You Know

Many drugs in development never make it to market.

One reason is that certain patient subsets metabolize drugs poorly which ends up contributing to adverse effects. The more you know about how patients metabolize drugs, the better.

By providing information on drug metabolization, pharmacogenetics can help to diminish noncompliance, drug failures, and waste in clinical trials.

The AmpliChip^® CYP450 Test identifies a patient genotype and provides a predicted phenotype—poor, intermediate, extensive, or ultrarapid metabolizer—so you can create more individualized dosing recommendations for drugs being evaluated in your trials.

By profiling patient metabolism before conducting and designing clinical trials, your product can maximize success with more predictable trial outcomes and increased speed to market.

If you would like a companion test to use in clinical trials, please contact us for more information.