Johns Hopkins recommends pharmacogenetic tests need more oversight

 (Courtesy: BSIP VEM/Science Photo Library) 

Researchers from the Genetics and Public Policy Center at Johns Hopkins University are suggesting some companies are using misleading claims to push tests that have limited clinical validation — something they say may ultimately hurt the pharmacogenetics field.  They recommend that this type of testing needs more oversight and are calling for more regulation of the pharmacogenetic testing industry.  For example, they noted, the US Food and Drug Administration doesn’t regulate most laboratory-developed tests, though clinical laboratories are certified under the Clinical Laboratory Improvement Amendment (CLIA).

In particular, they focused on tests for genetic variants in CYP450 genes. These genes code for enzymes involved in the metabolism of many drugs, including selective serotonin re-uptake inhibitors (SSRIs). Because of this relationship, there has been a great deal of interest in using CYP450 variants to predict drug treatment responses, especially for SSRIs.

And while there certainly has been a lot of research to identify variants of potential interest in disease risk or treatment, “finding the variants is only part of the story,” author Gail Javitt advises. She adds “There is no mechanism to ensure that genetic tests are supported by adequate evidence before they are marketed or the marketing claims for such tests are truthful and not misleading.”

Some of those offering pharmacogenetic tests have already refuted the claim.  They argue that where scientific data is available to support pharmacogenetic tests, individuals should be free to learn their genotype and how it might affect their response to drugs and other treatments.

Elaine Warburton  www.geneticsandhealth.com