A little over five years ago, Harmonyx was launched to offer pharmacogenetic testing to assist patients in taking the correct prescription medication based on their genetic information. Each person’s genetic makeup influences their body’s response to medicine, and pharmacogenetic testing helps predict that response. Through Harmonyx, we wanted to help bring scientific research into application through prescription medication, and in the case of our first test, clopidogrel (Plavix) efficacy, help prevent heart attacks or strokes.
We pursued partnering with prescribing physicians to impact their patients' lives through personalized medicine, remaining resilient and determined on our mission to change the way medicine was prescribed. Then in 2014, we saw an advocate that was right in front of us: the pharmacist.
Harmonyx launched a pharmacy-based program, empowering pharmacists to offer tests by screening patients for appropriateness, obtaining a prescription for the test by an independent state licensed physician, and working directly with treating physicians to provide results and patient care. The program grew to over 7,000 pharmacy partnerships nationwide, with four different test offerings. In November 2015, the United States Food and Drug Administration (FDA) informed us that because the tests were "patient-initiated," such tests are considered "direct-to-consumer" and required special approval through their agency.
Acknowledging that this process would cost tens of millions of dollars to generate the clinical research needed for direct-to-consumer access approval, we knew this was, unfortunately, not an option.
We still believe in pharmacogenetic testing and the impact it can have in providing guided prescription therapy to patients and families. We are grateful for the thousands of pharmacists and handful of physicians who partnered with us in championing the cause of personalized medicine.
We hope someday that the dream of affordable, personalized medicine will become a reality. Also, we hope the FDA will continue to review the clinical research regarding pharmacogenetic testing so patients can have affordable access to personalized medicine.
Harmonyx was a great cause, completely worth fighting for. We knew that challenging the status quo would be a tall task, but we were willing to get our hands dirty and fight the good fight as long and as hard as possible.
Robert J Bean
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