InSource Diagnostics has announced that it is enlisting research sites to enroll patients in the SPHERE Registry for a clinical trial designed to validate biomarkers in urine that predict genetic mutations, which affect a patient's ability to properly metabolize medications. The drugs in this study are opioids, benzodiazepines, tryclyclic antidepressants and muscle relaxants. These include 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 expensive pharmacogenomics testing, which is often not reimbursed. Many insurance providers, including Medicare, have been reluctant to support this pharmacogenetic testing as a screening technique, because only about 10 percent of the population has the mutation. The SPHERE Registry offers a cost-effective solution, using 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.
The SPHERE Registry uses biomarkers measured in a routine urine drug test (UDT) to identify patients who may have the genetic factors for abnormal drug metabolism and are therefore good candidates for genetic testing. Utilizing a routine UDT as a screening tool reduces the number of unnecessary genetic tests and saves the healthcare system money. UDT is already considered the standard of care for assessing compliance or potential abuse in patients who are prescribed controlled substances for more than 90.
"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," said 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."