Longitudinal study to evaluate the relationship of genetic variability and clinical pain management outcomes
SAN DIEGO, CA – August 21, 2012 – Millennium Laboratories, the leading research-based clinical diagnostic company dedicated to improving the lives of people suffering from pain, announced today that it has initiated a first-of-its-kind, large-scale prospective clinical outcomes study of its pharmacogenetic test. The study, which will encompass more than 30 practice sites nationally, is designed to evaluate the relationship between CYP genotype, as determined by Millennium PGT – Pharmacogenetic Testing, and clinical outcomes including level of analgesia, functional status, and clinically significant opioid-related adverse events. The study will also seek to assess the benefit to prescribers of pharmacogenetic information arising from Millennium PGT, and characterize any corresponding changes in prescribing patterns.
“Our company’s commitment to furthering the science and field of pain management includes providing research that supports best practices,” said Howard Appel, President of Millennium Laboratories. “To that end, this study will seek to expand and improve an understanding of how genetic variability affects response to prescribed medications to help improve medication choices, efficacy, and minimize side effects – potentially resulting in improved patient care.”
“Pharmacogenetic testing can provide valuable information through the detection of genetic variations in enzymes associated with the metabolism of medications commonly prescribed to patients suffering from debilitating chronic pain and pain-related effects. Utilized in combination with urine drug testing, it offers significant potential to improve the safety and efficacy of drug treatment and reduce adverse effects among certain patients,” said Michael Brennan, M.D., a nationally recognized pain specialist practicing in Fairfield, Connecticut. “Ongoing research such as the major study announced today by Millennium will be critical in helping to facilitate a better understanding of the important role this new tool can play in pain management.”
The largest study of its kind, up to 1,250 subjects meeting the study entry criteria will be enrolled into the initial, cross-sectional phase. Subjects categorized by the test as poor or ultra-rapid metabolizers will continue into the longitudinal phase of the study.
About Millennium PGT – Pharmacogenetic Testing
Millennium PGT saliva-based testing detects genetic variations in enzymes associated with the metabolism of medications commonly prescribed to patients suffering from debilitating chronic pain and related symptoms. Designed to serve as an objective tool to support individualized therapy, the test will help clinicians identify patients who may benefit from modifying the drug selection or dosing of certain prescribed opioids including methadone, benzodiazepines, tricyclic antidepressants (TCAs), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs).