PRESS RELEASE

InSource Diagnostics Launches Clinical Trial Focused on PGx and Abnormal Drug Metabolism Screening

Physicians' offices invited to become research sites and enroll patients

Monrovia, Calif. (July 13, 2016) – InSource Diagnostics announced today 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. (See addendum for complete list of study drugs.) 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. Details about participation guidelines can be found at: http://www.insourcedx.com/sphere/index.html

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."

InSource Diagnostics is a CLIA-certified clinical diagnostic laboratory that offers a large test menu, including therapeutic drug monitoring and drugs-of-abuse testing. Founded and staffed by scientists, the company delivers patient testing for an extensive list of drugs and substances, using liquid chromatography/tandem mass spectrometry (LC/MS/MS) and high-complexity immunoassays. One of the largest labs in California, InSource Diagnostics operates a 7,290 square-foot testing facility at its headquarters in Monrovia. Founded in 2012, InSource Diagnostics serves customer nationwide and maintains a sales force located strategically throughout the U.S.

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Contacts for the Media:
Jennifer Dahlgren, Dahlgren Communications
(530) 263-6817
dahlgrenpr@comcast.net

Sky Countryman, CEO, InSource Diagnostics
(626) 386-5277
skyc@insourcedx.com


Addendum

Medications Evaluated by the SPHERE Clinical Trial

The table below lists the drugs being evaluated for the trial and the corresponding genes involved in metabolism. If the trial is successful, we hope to add additional drugs in the future that have genetic implications.