SOURCE: Genomind

February 26, 2014 09:00 ET

Genomind Announces New Patient Outcomes Data Supporting Use of the Genecept Assay

Data Reported by Patients and Their Clinicians Shows Clinically Significant Improvement After Use of the Genecept Assay

CHALFONT, PA--(Marketwired - February 26, 2014) - Genomind, a personalized medicine company, presented data strongly supporting the utility of pharmacogenomic testing in improving outcomes for psychiatric patients, using their Genecept Assay. Response rates exceeded those reported in the seminal STAR*D trial for patients with depression.

Genomind's innovative Open Label Study was presented at the Annual Meeting of the American Society of Experimental NeuroTherapeutics (ASENT) in Bethesda, Maryland last week. The poster was titled, "Clinical Utility of Pharmacogenetic Testing in Psychiatric Patients in a Naturalistic Open Label Study". The poster abstract will be published in the June edition of Neurotherapeutics. The mission of ASENT is to advance the development of improved therapies for disorders affecting the nervous system.

The Open Label Study is a naturalistic study assessing the impact of the Genecept Assay on the treatment of patients with psychiatric illnesses. The study began in April 2013 and will conclude by the end of the first quarter of this year. Data are being collected from both clinicians and patients.

Completed psychiatric rating scales related to 659 patients show the following:

  • 60% of patients were described as being at least "moderately ill" at baseline by their treating clinicians. Clinicians completed the CGI-I to assess improvement in the patients over a three month time period;
  • 89% of patients showed clinically measurable improvement after assay-guided treatment; 
  • 90% of treatment resistant patients, defined as having two or more failed treatment trials, showed clinically measurable improvement after assay-guided treatment;
  • There were significant decreases in patient-reported depression, anxiety, and side effects;
  • There were significant increases in patient-reported quality of life; and
  • Both clinician-reported response rates (assessed by the CGI-I), and patient-reported response rates (assessed by the depression inventory) exceeded the seminal STAR*D depression trial for all patients, regardless of number of previous failed treatment trials. 

"We are extremely excited to share additional data that indicates incorporation of pharmacogenomic information from the Genecept Assay into treatment of psychiatric patients improves symptoms and reduces medication side effects," said Dr. Jay Lombard, Chief Scientific Officer and Medical Director, Genomind. "This interim data analysis is highly significant, especially when considering the previously reported response rates in individuals who have had multiple treatment trial failures. The findings of this study suggest that pharmacogenomic testing in treatment resistant patients may be an integral tool to enhance treatment outcomes."

These data strongly support the utility of genetic testing in the treatment of psychiatric patients, and both clinician and patient reported outcomes indicate clinically significant improvement in severity of illness after utilization of genetic information to guide treatment decisions. A final publication will be prepared once data collection is completed. These data supporting the efficacy of assay-guided treatment add value to previous Genomind studies showing that use of the Genecept Assay improves patient adherence to their medications and decreases healthcare costs. 

About Genomind

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.

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/products/assay.

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