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ValueOptions And Genomind Announce Innovative Study Of Pharmacogenomic Testing For Treating Psychotic Disorders

ValueOptions®, Inc. a health improvement company specializing in mental and emotional well-being and recovery, and Genomind, a personalized medicine company, recently announced an innovative study that uses pharmacogenomic testing to treat patients diagnosed with psychotic disorders, including schizophrenia and bipolar disorder. The study will be conducted at North Shore-LIJ Health System’s Zucker Hillside Hospital, a nationally recognized behavioral health center in Glen Oaks, NY.

Extensive Scientific Data Supports the Clinical Validity of Pharmacogenomic Testing for Predicting Patient Response to Psychiatric Medications

AssureRx Health, a leading personalized medicine company, recently announced that the International Review of Psychiatry published an extensive review that validates the clinical use of pharmacogenomic testing to help predict patient response to psychiatric medications and improve treatment outcomes.

Joint Assurex Health and Mayo Clinic Study Demonstrates Clinical Utility of Assurex Health’s Pharmacogenomic Test to Guide Treatment of Major Depressive Disorders

Assurex Health, a personalized medicine company focused on pharmacogenomics for neuropsychiatric disorders, recently announced the publication of a joint clinical study conducted by Assurex and Mayo Clinic which provides additional evidence for the effectiveness of the GeneSight pharmacogenomic test over the current method for selecting psychotropic medications. The study results were published on July 24, 2013 in Pharmacogenetics and Genomics. The primary outcome of the study showed a substantially greater baseline to endpoint decrease in depressive symptoms with higher rates of response and remission in the guided GeneSight group over empiric prescribing, which is the current standard of care. These results reinforce the benefit of GeneSight in providing more objective, evidence-based support for clinicians in selecting medications for patients with psychiatric disorders.

The prospective clinical trial, involving 227 participants divided into pharmacogenomic-guided treatment and treatment-as-usual groups, utilized the GeneSight interpretive report to categorize 26 antidepressants and antipsychotics into color-coded green, yellow, and red “bins” based on each participant’s genetic information and pharmacology of the medications. Significantly greater reductions in symptoms were observed for the GeneSight-guided group using multiple symptom rating scales completed by both clinicians and patients. Participants in the GeneSight-guided group experienced an overall greater than 2-fold improvement in both symptoms and likelihood to achieve remission.

Overall, results with GeneSight-guided treatment were superior to unguided treatment-as-usual. The study showed the ability of GeneSight to identify individuals who are likely to have a favorable outcome with specific pharmacotherapies, supporting the clinical utility of the GeneSight test. A four-fold greater improvement in depressive symptoms was observed in the GeneSight-guided group among participants who entered the study on medications most discordant (red-bin) with their pharmacogenomic profile.

Physicians for nearly 94% of patients in the GeneSight-guided group used the report to either switch participants off medications discordant with their genetics to medications in the green bin or to adjust medication dosages according to the participant’s GeneSight report.

These findings replicate and expand on the magnitude of the effect observed in a previous prospective joint clinical study from Assurex and Mayo Clinic published in Translational Psychiatry (Oct. 2012). This smaller study compared GeneSight-guided prescribing versus treatment-as-usual in adult patients with a primary diagnosis of a major depressive disorder over an 8 week period. Furthermore, a one-year blinded retrospective study of adult patients with a diagnosis of depressive or anxiety disorder published in Translational Psychiatry (Mar. 2013) demonstrated that patients taking discordant red bin medications based on the GeneSight report had substantially higher rates of medical utilization, 3-fold greater medical absence days, and 4-fold greater medical disability claims than patients on non-red bin medications.

“Multiple clinical studies have now demonstrated the clinical validity and clinical utility of our integrated, GeneSight combinatorial pharmacogenomic testing platform,” according to Bryan M. Dechairo, Ph.D., Senior Vice President, Medical Affairs & Clinical Development at Assurex Health. “Prescribing a medication regimen that is more likely to succeed because it is tailored to an individual patient’s genetic profile can help clinicians better manage each patient’s disorder and improve clinical outcomes.”

Source: PR Newswire

Epigenomics AG Announces Non-exclusive Licensing Agreement for Septin9 with Companion Dx Reference Lab

Epigenomics AG (Frankfurt Prime Standard: ECX), the German-American cancer molecular diagnostics company, announced today that it signed a non-exclusive licensing agreement for its proprietary DNA methylation biomarker Septin9 with Companion Dx Reference Lab (“Companion Dx”), an emerging leader in pharmacogenomic testing and cancer companion diagnostics. Under the terms of the agreement, Companion Dx has obtained rights to establish and commercialize a blood-based, laboratory-developed test (LDT) using methylated Septin9 as biomarker for the detection of colorectal cancer. Epigenomics is entitled to double digit royalties on sales.

“The addition of Septin9 to our offering of cancer related products will allow us to more effectively serve the Texas cancer testing market. Colorectal cancer is the second leading cause of cancer-related deaths in the U.S., and we believe that the blood based method to detect colorectal cancer in the currently non-compliant patient population will improve participation in screening and therefore save more lives in Texas”, said Steve Blum, CEO of Companion Dx.

“Based on the growing uptake of the Septin9 assay through our LDT licensees, we are excited to add regionally focused Companion Dx lab to the list of our partners as we recognize their ability to reach incremental sub-populations who should be but are not currently screened according to guidelines”, said Noel Doheny, Chief Executive Officer of Epigenomics’ US subsidiary. “Companion Dx shares our objective of providing tests that will help physicians to improve the health outcomes for patients through accurate detection of colorectal cancer and to potentially decrease the rising costs associated with colorectal cancer in the U.S. With today’s licensing agreement, we continue to execute on our commercialization strategy, well ahead of the launch of a proprietary diagnostic product approved by the FDA”, explained Mr. Doheny.

The agreement with Companion Dx complements Epigenomics’ LDT agreements with Quest Diagnostics, ARUP Laboratories and Warnex Medical Laboratories in North America. Furthermore, Abbott Molecular has worldwide, non-exclusive license to develop and to commercialize IVD test kit products while Qiagen and Sysmex have acquired options to do so.

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Transgenomic Picks Up Clinical Data’s MDx and Biomarker Business for $15.4M

Transgenomic is buying Clinical Data’s genetic and pharmacogenomic testing and biomarker development business for approximately $15.4 million. The transaction will allow Clinical Data to focus its resources solely on therapeutic development.