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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

Imaging in Mental Health and Improving the Diagnostic Process

What are some of the most troubling numbers in mental health? Six to 10 — the number of years it can take to properly diagnose a mental health condition. Dr. Elizabeth Osuch, a Researcher at Lawson Health Research Institute and a Psychiatrist at London Health Sciences Centre and the Department of Psychiatry at Western University, is helping to end misdiagnosis by looking for a ‘biomarker’ in the brain that will help diagnose and treat two commonly misdiagnosed disorders.

Major Depressive Disorder (MDD), otherwise known as Unipolar Disorder, and Bipolar Disorder (BD) are two common disorders. Currently, diagnosis is made by patient observation and verbal history. Mistakes are not uncommon, and patients can find themselves going from doctor to doctor receiving improper diagnoses and prescribed medications to little effect.

Dr. Osuch looked to identify a ‘biomarker’ in the brain which could help optimize the diagnostic process. She examined youth who were diagnosed with either MDD or BD (15 patients in each group) and imaged their brains with an MRI to see if there was a region of the brain which corresponded with the bipolarity index (BI). The BI is a diagnostic tool which encompasses varying degrees of bipolar disorder, identifying symptoms and behavior in order to place a patient on the spectrum.

What she found was the activation of the putamen correlated positively with BD. This is the region of the brain that controls motor skills, and has a strong link to reinforcement and reward. This speaks directly to the symptoms of bipolar disorder. “The identification of the putamen in our positive correlation may indicate a potential trait marker for the symptoms of mania in bipolar disorder,” states Dr. Osuch.

In order to reach this conclusion, the study approached mental health research from a different angle. “The unique aspect of this research is that, instead of dividing the patients by psychiatric diagnoses of bipolar disorder and unipolar depression, we correlated their functional brain images with a measure of bipolarity which spans across a spectrum of diagnoses.” Dr. Osuch explains, “This approach can help to uncover a ‘biomarker’ for bipolarity, independent of the current mood symptoms or mood state of the patient.”

Moving forward Dr. Osuch will repeat the study with more patients, seeking to prove that the activation of the putamen is the start of a trend in large numbers of patients. The hope is that one day there could be a definitive biological marker which could help differentiate the two disorders, leading to a faster diagnosis and optimal care.

In using a co-relative approach, a novel method in the field, Dr. Osuch uncovered results in patients that extend beyond verbal history and observation. These results may go on to change the way mental health is diagnosed, and subsequently treated, worldwide.

Study: Correlation of brain default mode network activation with bipolarity index in youth with mood disorders [Journal of Affective Disorders]

Source: EurekAlert!

Assurex Health Releases Major Update to GeneSight Psychotropic Test Panel

Assurex Health recently announced the release of GeneSight® Psychotropic 2.0, its lead psychiatric pharmacogenomic test panel. This latest GeneSight Psychotropic version has been updated to include four additional medications that now cover a total of 36 of the most commonly prescribed psychotropic medications in the US. The added antidepressant and antipsychotic medications include Viibryd® (vilazodone), Latuda® (lurasidone), Saphris® (asenapine), and Invega® (paliperidone). Additionally, the GeneSight Psychotropic 2.0 report includes information for 17 psychotropic medications that have pharmacogenomic information in their FDA approved labels.

“Assurex Health is committed to bringing the latest clinical and scientific findings to support clinicians and their patients in selecting medications to treat neuropsychiatric disorders,” according to Bryan M. Dechairo, Ph.D., Senior Vice President, Medical Affairs & Clinical Development at Assurex Health. “GeneSight Psychotropic 2.0 now includes recently approved FDA medications, a new gene polymorphism, and easy-to-understand information to help categorize individual psychotropic medications.”

GeneSight is a unique pharmacogenomic treatment decision support product that tests for clinically important genetic variants affecting a patient’s response to psychiatric medications. GeneSight provides information that helps clinicians make informed, evidence-based decisions about proper drug selection, delivered in a simple and easily understood report. Prescribing a medication regimen that is more likely to succeed because it is tailored to an individual patient’s genetic profile can help the clinician better manage the patient’s disease and improve patient outcomes.

A Mayo Clinic prospective clinical study published recently in Translational Psychiatry (Oct. 2012) compared GeneSight-guided prescribing versus treatment-as-usual prescribing in adult patients with a primary diagnosis of a major depressive disorder over an 8 week period. The study found up to a 4-fold increase in symptom improvement for GeneSight-guided patients. An Assurex Health sponsored one-year blinded retrospective study of adult patients with a diagnosis of depressive or anxiety disorder, also published recently in Translational Psychiatry (Mar. 2013), demonstrated that patients taking genetically inappropriate or “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 study patients on non-red bin medications.

Source: Assurex Health

AAPA Poster Presentation Explores Connection between Biomarkers and Science-Based Personalized Nutrition Therapy in the Management of Major Depressive Disorder

An examination of the latest genetic and physiologic biomarker research and its application in viable therapeutic options for patients with Major Depressive Disorder (MDD) was the focus of a breakthrough poster presentation which debuted at the American Academy of Physician Assistants (AAPA) annual conference, IMPACT 2013. The poster and complete study findings were presented by Ian V. Mackey, M.S., P.A.-C, Physician Assistant, Rush University Medical Center.

Building on data that shows obesity and inflammation predict poorer response to antidepressant therapy, the poster shed light on the link between biomarkers associated with conditions of inflammation, oxidative stress, and obesity and a patient’s potential response to treatment with adjunctive L-methylfolate. The presentation was aimed at helping inform and educate physician assistants (PA), who are often the first line of defense for patients presenting with MDD and critical to the proper treatment of the condition. The poster findings also come on the heels of a study published in the American Journal of Psychiatry which demonstrated twice as many patients responded when given adjunctive L-methylfolate 15mg compared to adjunctive placebo (continuation of SSRI monotherapy). In terms of tolerability, discontinuations due to adverse events were no different than placebo when adding L-methylfolate to SSRI treatment in patients with MDD.

“It’s vital that we make it a practice to assess the patient as a whole as opposed to assessing just their symptoms of MDD,” said Ian Mackey, M.S., P.A.-C. “As these findings indicate, other medical problems, concomitant medications and inflammation are becoming increasingly important in choosing the correct interventions for patients with MDD.”

Taking into account MDD can include metabolic components associated with poor Selective Serotonin Reuptake Inhibitors (SSRI) response, the poster presentation, Effect of L-methylfolate on Inflammatory Markers a Randomized Clinical Trial of Patients with Major Depression, analyzed 75 outpatients inadequately responding to an SSRI who were enrolled in a 60-day study, divided into two, 30-day evaluation periods according to Sequential Parallel Comparison Design (SPCD). Patients were randomized to receive L-methylfolate 15mg + SSRI for 60 days; placebo + SSRI for 30 days followed by L-methylfolate 15mg + SSRI for 30 days; or placebo + SSRI for 60 days. The SSRI doses remained constant during the study. Pooled 30-day results demonstrated significantly greater benefits in all-comers with adjunctive L-methylfolate 15mg + SSRI compared to placebo + SSRI (continued SSRI monotherapy). The magnitude of difference between response to adjunctive L-methylfolate and adjunctive placebo was 17.7% (p=0.04). Pooled differences in mean change on HDRS-17 and HDRS-28 were significantly greater (p=0.05 and p=0.02 respectively) with L-methylfolate superior to placebo.

Results also show that patients with SSRI-resistant MDD stratified by biomarkers of inflammation (hsCRP), oxidative stress (4-HNE) and methylation (SAM/SAH ratio) responded better to adjunctive L-methylfolate 15mg compared to adjunctive placebo. In an analysis of a priori endpoints, patients with baseline levels of hsCRP at or above the median (p=0.05) and 4-HNE (p=0.003) at or above the median and SAM/SAH ratio below the median (p=0.005) experienced a significantly greater treatment effect in favor of adjunctive L-methylfolate. In an exploratory analysis, patients with obesity defined as BMI ≥30 kg/m2 demonstrated a significantly greater treatment effect with adjunctive L-methylfolate versus adjunctive placebo (p=0.001).

The AAPA’s annual conference is focused on identifying and discussing innovative solutions that empower PAs at all stages of their careers to improve patient health. IMPACT 2013 remains the largest PA-focused Continuing Medical Education (CME) event in the world, with approximately 6,000 PAs and students in attendance. IMPACT 2013 took place May 25-29 at the Walter E. Washington Convention Center in Washington, D.C.

Source: Business Wire

Ridge Diagnostics, Inc. and Ameritox Ltd. Enter Into Licensing Agreement for Depression Biomarker Blood Test

Ridge Diagnostics, Inc., a neurodiagnostic company, announced today it has entered into an exclusive agreement with Ameritox, Ltd., a leader in medication monitoring, for the license rights to its proprietary developmental blood test MDDScore, a multiple biomarker analysis for Major Depressive Disorder (MDD) for primary care and pain physicians. As part of the agreement, Ameritox has agreed to make an undisclosed equity investment in Ridge and commit to a next-stage clinical development program.