Quantcast

Industry news that matters to you.  Learn more

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®).

Luminex Corporation Receives FDA and European Clearance for a New Personalized Medicine Genotyping Assay, xTAG CYP2C19 Kit

Luminex Corporation (NASDAQ: LMNX) recently announced it has received U.S. FDA and European clearance for a comprehensive genotyping assay, xTAG® CYP2C19 Kit. This new test enables a personalized approach to aid physicians in determining patient treatment plans based on certain genetic variants of the P450 2C19 gene.

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

Biomarker Assessment in Suspected ACS Could be Practice-changing: BIC-8 Results

An emergency department strategy that uses two biomarkers to triage patients with suspected acute coronary syndrome (ACS) can increase the rate of early, safe hospital discharge, according to results of the Biomarkers in Cardiology 8 (BIC-8) trial.

“This biomarker strategy using a state-of-the-art quantitative troponin assay in combination with an ultrasensitive copeptin assay has the potential to change clinical practice with high patient safety,” said lead investigator Martin Möckel, MD, PhD, from Charité – Universitätsmedizin Berlin, in Berlin, Germany.

“This is the first interventional trial to study whether it is safe to discharge suspected ACS patients who test troponin and copeptin negative at admission. Using this strategy, a high proportion of patients could be discharged early, thus unnecessary treatments and resources could be saved, causing a substantial benefit for patients and health care providers.”

Emergency departments worldwide face increasing overcrowding and patients with signs and symptoms which might be caused by an acute coronary syndrome are very common, even though only around 15% of these patients are ultimately diagnosed with an acute myocardial infarction as the underlying disease, explained Dr. Möckel.

“Rapid rule-out of acute myocardial infarction (MI) is therefore a major clinical need, saving the health care system time and resources and patients unnecessary stress, anxiety and other risks associated with hospitalization.”

Current guidelines recommend that patients receive serial troponin testing to confirm that hospital discharge is appropriate, but this testing delays definitive action, he said.

“The new biomarker copeptin has been shown to be elevated in patients first presenting with acute MI, and when combined with the cardiac troponin biomarker has an excellent negative predictive value for acute MI. However, an early discharge strategy based on combining these two tests has never been assessed prospectively.”

BIC-8, a multicentre, open, randomized, controlled clinical trial included 902 patients with an initial negative troponin test to assess this strategy.

In the experimental arm (n=451), patients with a negative copeptin test (less than 10 pmol/L) were discharged into ambulant care, with a scheduled outpatient visit within 72 hours, while those with a positive copeptin test received standard treatment according to current guidelines.

Among patients in the standard arm (n=451), copeptin results were not available to treating staff and patients were treated according to current guidelines.

At 30 days of follow-up the rate of major adverse cardiovascular events (MACE) was similar in both groups (5.46% in the experimental arm vs 5.5% in the standard arm), but emergency room discharge rates were significantly higher in the experimental arm (66% vs 12%; P < 0.001).

The results support the consideration of a new treatment algorithm in low-to-intermediate risk patients with suspected ACS, said Dr. Möckel.

“Patients with a negative troponin and a negative copeptin result at admission can safely be discharged if the final clinical assessment is consistent with this decision, as long as a timely diagnostic work-up is done in the outpatient setting,” he said.

However, the clinical judgment of the treating physician is of utmost importance, he stressed.

“If his or her final clinical assessment excludes discharge due to high suspicion of ACS, perhaps due to recurrent symptoms or an updated history, the patient should not be discharged despite negative biomarker results.”

Source: EurekAlert!

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!