Pharmacogenomics—the science of how genes affect a person’s response to drugs—has been around for several years now, and if present trends and scientific advances continue, could soon be entering the mainstream of medical care.

“I believe that we are right on the cusp of a major change to acceptance of pharmacogenomic tests,” said Dr. Tim Wiltshire, Director of the Center for Pharmacogenomics and Individualized Therapy at the University of North Carolina (UNC) Eshelman School of Pharmacy.

According to Wiltshire, the primary issues that have slowed acceptance of the tests are that they have been seen to be not cost-effective or cheap enough or available enough, along with a lack of knowledge in the medical community. But, he said, “We’ve made big strides, because now there are multiple companies  offering pharmacogenomic tests, like GeneSight, and more and more people are getting these tests done.”

With costs coming down and the robustness of results going up, it seems inevitable that pharmacogenomic tests are ready for prime time in the healthcare arena.

Clinicians catching on

With pharmacogenomic testing reaching critical mass in the marketplace and rising to front of mind in consumers, clinicians will undoubtedly be more inclined to employ services like GeneSight, Wiltshire felt. “I understand that many clinicians did not get training for this through their medical training, because it wasn’t available. So they don’t necessarily know about it. Also, the cost of the assay has been rather high, and they have often said, ‘Well, I think we can manage our way through this.’ As costs come down and the tests become much more readily available, it will take away that reason for not using the information.”

Consumer demand is a driver

Wiltshire expects to see an increasing awareness and resulting demand for pharmacogenomic testing among consumers, thanks to word-of-mouth among people who have had the tests in tandem with direct-to-consumer advertising. “I think that’s going to be a big turning point that is actually going to push clinicians into using the tests more. When a patient comes and says, ‘I heard there’s a test for this,” it puts the clinician into a position of having to know about it, and then making a rational decision as to whether to use it or not.”

He hopes that trend will result in more pre-emptive use of pharmacogenomic tests, with the tests being administered prior to a specific prescription being written. Such foreknowledge may save time and money, and may also prevent ineffective and/or harmful pharmaceutical treatment by arming the doctor and patient with solid, predictive information about the likely success of a particular course of treatment.

Regulatory environment also evolving

Pharmacogenomics is also having a growing impact in drug development, clinical trials, and the regulatory world. “This is also changing very rapidly,” said Wiltshire, “in that now the pharma companies are having to bring along genetic markers of efficacy or toxicity as part of their assignment for a clinical trial.” Five years ago, he observed, it was still too costly and the knowledge base was still too incomplete to require that information.

“Now, that’s not really an excuse, as regulatory agencies like the FDA are changing quite rapidly in terms of requiring more of this data to come along with new drugs coming onto the market.”