Study to Evaluate Impact of the Genecept™ Assay on Patients Outcomes
Incorporates New Web-based Data Collection Approach
CHALFONT, PA – May 7, 2012 – Genomind, a company specializing in neuropsychiatric personalized medicine, today announced that it will launch its uniquely-designed Open Label Study at the Annual American Psychiatric Meeting (APA) May 5-9, 2012 in Philadelphia, PA. The study will follow the clinical outcomes of using the Genecept™ Assay, a genetic test to help clinicians select the most beneficial treatment approach for psychiatric conditions, based on the patient’s individual, genetic make-up. The test is particularly focused on patients with treatment resistant psychiatric disorders. Dr. Jay Lombard, Chief Scientific Officer and Medical Director at Genomind, will discuss how the Genecept Assay, a simple to use, noninvasive saliva-based diagnostic tool, can help inform treatment planning decisions based on patients’ genetic biomarkers at a breakfast-session on Monday, May 7 from 7:45am to 8:45am during the APA meeting. Genomind will also be exhibiting at Booth #1606 at the Pennsylvania Convention Center Sunday, May 6, 2012 to Tuesday, May 8, 2012 from 10:00am to 4:00pm.
“A patient typically needs to go through a long process of trial and error with several psychotropic medications before efficacy, side effects and overall behavioral changes can be evaluated,” said Dr. Lombard. “The Genecept Assay helps clinicians to more quickly assess the likelihood that certain medications will work on a specific patient. Based on the test results, the clinician will be better informed about the most effective treatment options for the patient. Results of the test can improve clinical outcomes while reducing time and costs for both patients and clinicians, and also minimize the potential for adverse side effects.”
The protocol for the Open Label Study will be presented at a poster session (#NR9‑19), “A Virtual Study Design to Reduce ‘Real World’ Challenges of a Depression Study” at APA on Tuesday, 11:00am to 12:30pm. The study was designed to enable efficient, timely reporting of clinical and genetic information from “real-world” settings. Clinicians, hospitals and health systems are invited to participate in the study as soon as they order the test kits. All surveys are completely accessible online to facilitate ease of use and achieve greater compliance amongst clinicians and patients. Study participants will be able to sign up for email and SMS text reminders to facilitate reporting.
The study is expected to demonstrate changes in prescribing patterns, cost savings to the health system, improved medication compliance, and improved clinical outcomes following Genecept Assay testing. Clinicians will complete an online questionnaire to benchmark the severity of patients’ symptoms and a post-treatment survey (three months after the baseline evaluation) to measure changes in patient condition. Participating patients will complete a series of online questionnaires regarding their symptoms and quality of life at baseline, and 1-month and 3-months intervals following treatment. Patients will also be able to report any side effects experienced, as well as their level of overall satisfaction with treatment.
“The Open Label Study is a new and innovative way for us to expand the ever growing amount of data from actual clinical practice that illustrates genetic testing’s promise in advancing the field of psychiatry,” said Dr. Stephen M. Stahl, Professor of Psychiatry at University of California, San Diego and Honorary Fellow at University of Cambridge and a member of Genomind’s Scientific Advisory Board. “Genetic testing has been employed in fields such as oncology and anticoagulation, but less commonly in psychiatry. The study is a simple, nonintrusive methodology that will enable us to collect and share the first hand experiences that our clinicians and their patients have had with the Genecept Assay.”
The Open Label Study is the third study announced this year that employs the Genecept Assay. Massachusetts General Hospital began a major inpatient study in February comparing treatment-as-usual vs. assay-guided treatment in inpatient adults with treatment resistant depression. Genomind has also partnered with Centerstone, the nation’s largest provider of community-based behavioral healthcare, for an outpatient pilot study examining the use of genetic biomarker data in assisting clinicians with treatment selections for patients with major depressive disorder. For more information on these studies, please visit http://www.clinicaltrials.gov.
About the Genecept™ Assay
The Genecept Assay is a comprehensive, simple-to-use tool for understanding genetic and biological markers that best inform response to different psychiatric treatments. The Assay is Genomind’s core product, and contains a proprietary panel of biomarker tests, an analytic report, and a psychopharmacologist consultation. The Assay can be used for a range of psychiatric conditions including depression, bipolar disorder, schizophrenia, anxiety disorders, OCD and ADHD. For more information on the Assay, including information about the specific genes in the panel, please visit http://www.genomind.com/how-it-works/.
Genomind is a personalized medicine company, comprised of innovative researchers and expert leaders in psychiatry and neurology. Genomind is committed to discovery of the underlying causes of neuropsychiatric disorders and supports the development of personalized medicine that improves patients’ lives. Genomind was founded by Ronald I. Dozoretz, MD, a psychiatrist who has devoted his career to improving mental health. Jay Lombard, DO, a neurologist and co-founder of Genomind, is a critically acclaimed author and nationally recognized thought leader in neuropsychiatry practice and research. Learn more at http://www.genomind.com.
For more information, contact:
Marketing Manager, Genomind