InSource Diagnostics, Monrovia, Calif, is enlisting research sites to enroll patients in the Standard of Care Versus Urine Testing with Selective Pharmacogenomics for Effective Drug and Dosing Regimens (SPHERE) Registry for a clinical trial designed to validate biomarkers in urine that predict genetic mutations affecting a patient’s ability to properly metabolize medications. Drugs included in the study are benzodiazepines, opioids, tryclyclic antidepressants, and muscle relaxants, including the two most highly prescribed pain drugs: hydrocodone and oxycodone.
A genetic mutation in the cytochrome P450 family of enzymes, which reside in the liver, can lead to increased side effects or reduced therapeutic benefits for these drugs. The availability of information about a patient’s genetic metabolic status can help physicians reduce adverse drug events and prescribe more effectively.
Currently, the only way to identify patients with the mutation is through pharmacogenomic testing, which is often not reimbursed. Many insurance providers, including Medicare, have been reluctant to support such pharmacogenomic testing as a screening technique, because only about 10% of the population has the mutation. The SPHERE Registry uses information from a routine urine drug test to screen for patients who would likely benefit from DNA tests.
The study is currently enrolling 14,000 patients from 200 sites throughout the country. Physicians who prescribe medications on the list may enroll patients in the study and receive an honorarium of $50 for every patient who completes the 90-day trial. Qualifying patients will receive a free genetic test. Details about participation guidelines can be found at: www.insourcedx.com/sphere/index.html.
Sky Countryman, InSource Diagnostics.
“Participation in this clinical trial is a way for physicians to be a part of cutting-edge research and have an impact on how medications are prescribed,” says Sky Countryman, CEO of InSource Diagnostics. “This study will be of great interest to physicians in pain management, psychiatry, general and family practice, internal medicine, addiction, and rheumatology.”
For more information, visit InSource Diagnostics.
