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Study Shows that an FDA-cleared Biomarker can Help to Reduce ADHD Overdiagnosis

NEBA Health recently announced that Brain and Behavior has published validation results for the first biomarker cleared by FDA to assist a clinician in ADHD evaluation. Of particular note, the study shows that this brainwave-based test, NEBA, can reduce overdiagnosis by identifying children whose ADHD-like symptoms may be better explained by another condition.

UC Davis Study Finds Biomarker Differentiating the Inattentive and Combined Subtypes of ADHD

Using a common test of brain functioning, UC Davis researchers have found differences in the brains of adolescents with the inattentive and combined subtypes of attention-deficit/hyperactivity disorder (ADHD) and teens who do not have the condition, suggesting that the test may offer a potential biomarker for differentiating the types of the disorder.

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

NEBA Health Earns Patent for Integration of NEBA Biomarker with Clinician’s ADHD Evaluation

NEBA Health, LLC recently announced that Dr. Steven M. Snyder, Research and Development Vice President, has earned US Patent 8,509,884. The patent protects a key aspect of the NEBA system: integrating the biomarker with a clinician’s workup for ADHD. “NEBA is not a standalone diagnostic,” said Dr. Snyder. “After the clinician’s ADHD evaluation, NEBA helps them determine if the symptoms are due to ADHD or if further testing is warranted.”

“Integrating the NEBA biomarker with a clinician’s initial diagnostic impression can bring a clinician’s diagnosis more in line with that of multidisciplinary team,” said Dr. Snyder. Research supports that compared to a clinician alone, a multidisciplinary team is better able to determine if ADHD-like symptoms are accounted for by another condition.

In order to diagnose ADHD, a clinician not only observes criteria regarding behavioral symptoms and impairment, but also must determine whether symptoms would be better accounted for by another condition. Because ADHD shares symptoms with other disorders, the diagnosis may be difficult. According to the US Center for Disease Control and Prevention (CDC), 9.5% of all children and adolescents have an ADHD diagnosis. The ADHD diagnosis rate is increasing. CDC states that rates of ADHD diagnosis increased an average of 3% per year from 1997 to 2006 and an average of 5.5% per year from 2003 to 2007.

“In their ADHD evaluation, clinicians may be challenged in the current medical environment to determine the primary diagnosis when overlapping symptoms are present,” said Howard Merry, President of NEBA Health. “We are delighted that the USPTO has awarded Dr. Snyder the patent. It covers NEBA’s core technology, and it’s another validation point for the 7 years we spent developing and validating NEBA.”

Source: PR Newswire

Genomind Releases Statement Supporting NIMH Announcement to Move Away from DSM Categories

Genomind, a personalized medicine company, has released a statement in response to the National Institute of Mental Health’s (NIMH) announcement by Director Dr. Thomas Insel that the organization will be re-orienting its research away from DSM categories, supporting the move and its potential to influence improved treatment of patients with mental disorders.

DSM (Diagnostic and Statistical Manual of Mental Disorders) is a psychiatric diagnostics system based upon patient-reported symptoms that are used to define succinct syndromes and make medication choices. While the system has been in place for decades, it has not taken into consideration patient etiology or pathophysiology.

The remedy proposed by NIMH is the Research Domain Criteria (RDoC) Project, which would alter procedures to include genetics, imaging, cognitive science, and other specific endophenotypes which reflect specific changes in the brain associated with psychiatric conditions, creating a fuller understanding of both a patient’s disorder and how to best address treatment.

Genomind believes that the use of biomarkers in psychiatry can only help improve patient care. Better knowledge of a patient’s genetics can lead to better medication choices by reducing adverse drug side effects, which are based upon genetic impairments in drug metabolism. Continued research and focus on biomarkers may also help the industry understand underlying pathophysiological changes in the brain that lead to psychiatric disorders.

“The core of Genomind’s philosophy is that psychiatric disorders are dimensional, not categorical, and NIMH’s position directly supports this,” says Dr. Jay Lombard, Genomind’s Chief Scientific Officer and Medical Director. “We hope this move by the NIMH and the resulting RDoC Project will not only allow patients to receive more personalized, tailored care, but help the mental health community gain greater insight into how we can improve treatment even further in the future.”

Genomind is committed to discovery of the underlying causes of neuropsychiatric disorders and supports the development of personalized medicine that improves patients’ lives. The company’s core product is the GeneceptTM Assay, a comprehensive, simple-to-use tool for understanding genetic and biological markers that best inform response to different psychiatric treatments including depression, bipolar disorder, schizophrenia, anxiety disorders, autism and ADHD.

Source: Genomind