McLean and Genomind Prospective Study of Pharmacogenetic Testing

Importance / Relevance:

Psychiatric disorders are etiologically complex and clinically heterogeneous which makes them challenging to diagnose and effectively treat. Thus, they pose a huge societal burden and involve substantial costs in human and financial terms. Specifically in the U.S., mental health disorders including MDD and PTSD account for 6.2% of the nation's health care spending. Major depressive disorder and schizophrenia are listed by the World Health Organization as being among the top 10 leading causes of years lost due to disability.

The primary means of treating major mental illness remains psychotropic-based, whether alone or in combination with psychotherapy. Despite an ever-growing number of medication options, however, outcomes remain significantly suboptimal. In the landmark Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study, only 37% achieved remission with first-line therapy with a selective serotonin reuptake inhibitor (SSRI), whereas 16.3% withdrew completely from treatment due to drug intolerance. In the Clinical Antipsychotic Trails of Intervention Effectiveness (CATIE), over 74% eventually discontinued study medication either because of lack of efficacy or tolerability. And in the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) trial, up to 75% patients experienced symptoms relapse over the course of follow-up.

With the advent of the genomics revolution, and precision and personalized medicine, tailoring patients' medication treatment to their individual pharmacokinetic and pharmacodynamic characteristics is being increasingly embraced by various fields of medicine. Testing is currently available for cardiovascular, cancer, autoimmune, infectious, and psychiatric illnesses, etc. In fact, over 140 US Food and Drug Administration (FDA)-approved drugs have pharmacogenomic-based guidelines; at least 27 of these are psychotropics, including Celexa for which the FDA specially recommend dose-reduction for P450 CYP2C19 poor metabolizers due to the risk of QT prolongation (FDA, 2014). Yet the vast majority of Celexa-prescribing clinicians are unaware of which of their patients are among the 3% of poor metabolizers or the 20% of the intermediate metabolizers who are also at increased risk.

Genomind, a Pennsylvania-based personalized medicine company, provides genetic testing with the Genecept™ Assay that can help clinicians optimize treatment for their patients with mental illness. This test is an alternative to the traditional trial and error approach to psychiatric drug prescribing which fails approximately 50% of the time.