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Assurex Health Releases Enhanced Pharmacogenomic Test to Help Clinicians Select Medications for Depression, Anxiety and PTSD

Assurex Health recently announced an enhancement of its GeneSight® Psychotropic test, providing clinicians with the most comprehensive genetic-based tool available to help them make individualized antidepressant and antipsychotic medication decisions for patients with depression, anxiety, post-traumatic stress disorder (PTSD), bipolar disorder, schizophrenia and other behavioral health disorders. GeneSight Psychotropic now covers 38 FDA-approved medications, including recently approved levomilnacipran (Fetzima®) and vortioxetine (Brintellix®).

Assurex Health Appoints Veteran P&G Consumer Products Executive Virginia Coleman Drosos President to Lead Personalized Medicine Growth

Assurex Health, a personalized medicine company specializing in pharmacogenomics for neuropsychiatric and other disorders, recently announced that Procter & Gamble veteran Virginia “Gina” Coleman Drosos has joined its leadership team in the role of President.

Drosos joins Assurex Health with more than 25 years of global business leadership, innovation, operations and consumer marketing expertise. During her 25 year career at The Procter & Gamble Company (PG), Gina held positions of increasing responsibility in the United States and internationally delivering strong proven results. She most recently served P&G as Group President for Global Beauty Care, a $6 billion global business unit with over 6,000 employees in 120 countries. 

“Gina brings extensive leadership and strong results on global consumer-driven businesses,” said James S. Burns, CEO of Assurex Health. “I’m particularly excited about Gina joining the team because health care is rapidly moving into an era of patient-empowerment, leading a shift to consumer-enabled personalized medicine. In bringing neuropsychiatric pharmacogenomics to a market of 40+ million patients in the U.S. alone, Assurex will benefit from Gina’s experience in creating awareness and cultivating a huge base of patients/consumers/caregivers, 80% of whom are women as the primary medical decision maker.”

Assurex Health’s pharmacogenomic technology is a breakthrough in personalized medicine. Based on each patient’s personal genetic profile, GeneSight tests help clinicians determine the right treatment medications for patients with depression, ADHD, chronic pain and other neuropsychiatric disorders. “Eliminating today’s typical trial and error process for selecting medications can help people reclaim their lives and reduces healthcare costs,” said Drosos. “I look forward to applying my experience leading in the consumer space to help make personalized medicine a standard of care in the industry. With exciting new innovations in the pipeline and our technology-information-consumer platform, I’m confident Assurex will help more physicians and practitioners determine the best treatment options and lead the movement toward consumer-enabled personalized medicine.”

Drosos also serves on the Board of Directors for several major corporations including Signet Jewelers Ltd. (SIG) and American Financial Group (AFG). Drosos earned a Bachelor of Business Administration in Finance from the University of Georgia, a Master of Business Administration from The Wharton School, University of Pennsylvania, and was recognized as one of Fortune’s 50 Most Powerful Women in Business in 2010 and 2011.

Source: PR Newswire

Brain Inflammation Linked to More Severe Parkinson’s Symptoms

Reversing inflammation in the fluid surrounding the brain’s cortex may provide a solution to the complex riddle of Parkinson’s, according to researchers who have found a link between pro-inflammatory biomarkers and the severity of symptoms such as fatigue, depression and anxiety in patients with the chronic disease.

Lena Brundin of Michigan State University’s College of Human Medicine was part of a research team that measured inflammatory markers found in cerebrospinal fluid samples of Parkinson’s patients and members of a control group.

“The degree of neuroinflammation was significantly associated with more severe depression, fatigue, and cognitive impairment even after controlling for factors such as age, gender and disease duration,” said Brundin, an associate professor in the college and a researcher with the Van Andel Institute.

“By investigating associations between inflammatory markers and non-motor symptoms we hope to gain further insight into this area, which in turn could lead to new treatment options.”

The results of the study were published in the journal Brain, Behavior, and Immunity.

Inflammation in the brain long has been suspected to be involved in the development of Parkinson’s disease, specifically in non-motor symptoms such as depression, fatigue and cognitive impairment. Recent research suggests inflammation could drive cell death and that developing new drugs that target this inflammation might slow disease progression.

Parkinson´s disease is the second most common degenerative disorder of the central nervous system; the causes of the disease and its development are not yet fully understood.

“The few previous studies investigating inflammatory markers in the cerebrospinal fluid of Parkinson’s patients have been conducted on comparatively small numbers of subjects, and often without a healthy control group for comparison,” Brundin said.

In the study, 87 Parkinson’s patients were enrolled between 2008 and 2012. For the control group, 37 individuals were recruited. Participants underwent a general physical exam and routine blood screening. Researchers looked at the following markers: C-reactive protein, interleukin-6, tumor necrosis factor-alpha, eotaxin, interferon gamma-induced protein-10, monocyte chemotactic protein-1 and macrophage inflammatory protein 1-β.

The study was carried out in collaboration with researchers from Lund University in Sweden, Skåne University Hospital in Sweden and the Mayo Clinic College of Medicine in Florida.

Study: Cerebrospinal fluid inflammatory markers in Parkinson’s disease – Associations with depression, fatigue, and cognitive impairment [Brain, Behavior, and Immunity]

Source: EurekAlert!

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!

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