BioBehavioral Diagnostics Company (BioBDx) Announces Availability of Quotient™
ADHD System for Rapid, Objective, Office-Based Assessment of ADHD Symptoms
--Quotient™ ADHD System Enables Accurate Assessments in as little as 30 Minutes, with Instantaneous, Objective, Evidence-Based Reporting for Clinicians and Parents--
Cambridge, MA, May 8, 2008 – BioBehavioral Diagnostics Company (BioBDx) today unveiled its new Quotient™ ADHD System. The Quotient™ ADHD System is the first FDA-cleared test that offers medical professionals a private, office-based capability to quickly, objectively and accurately measure a child’s inability to inhibit abnormal levels of motor activity, sustain attention, and suppress impulsive response. Deficits in these neurological control functions are directly related to the core symptom domains of Attention Deficit Hyperactivity Disorder (ADHD): hyperactivity, inattention and impulsivity.
ADHD affects at least 4.4 million children ages 4 to 18 in the United States, according to the U.S. Centers for Disease Control and Prevention (CDC), with some estimates suggesting as many as 1 in 11 school-aged children suffer from some form of ADHD. Other recent studies suggest that nearly half of all children who have ADHD are never diagnosed with the condition by a health professional.
Children with ADHD are at significantly higher risk for injuries, perform less well in school than their non-ADHD peers, and can suffer from developmental and social issues that may cause them to become isolated from other kids their age. If left unaddressed, the impacts of ADHD often continue on into their adult lives, where research shows they often underachieve at work, have a higher incidence of substance abuse, and are more likely to exhibit anti-social behavior. As a result, it is critical to a child’s development and achievement that ADHD is recognized early and managed effectively over their lifetime.
Because nearly every child exhibits inattention, hyperactivity, and impulsivity (the core observable symptoms of ADHD) at one time or another, diagnosis of ADHD can be difficult. While teachers may be the first to notice hyperactivity in a child and refer to a school psychologist, they may not notice an ADHD-affected child who is inattentive and quiet. The child with ADHD must display symptoms in a way that goes beyond what is appropriate for that child’s age.
“Healthcare professionals have made great strides in advancing the ability to effectively diagnose and treat ADHD,” said Eric Gordon, founder and CEO of BioBDx. “However, accurate diagnosis depends on the quality of data available to clinicians, which today typically comes from parents and teachers, who often perceive and assess the symptoms of ADHD differently. That’s where an objective, office-based assessment tool like the Quotient™ ADHD System becomes valuable. Clinicians have found it effective in helping to quantify the three core symptom domains of ADHD, providing them with more information to aid in the diagnosis of their patients. Most importantly, it brings real benefit to children and adolescents with ADHD by helping to illuminate their symptoms.”
With a 15 to 20-minute, non invasive test, the Quotient™ ADHD System provides a clinician with objective measures of relevant neurological control functions, based on evoked response to stimuli. This information can then be used to develop a prompt and accurate diagnosis in a way that is consistently reproducible and reliably valid. After a child takes the Quotient™ ADHD System test, their physician can provide the family with a patient report that includes information about the results, and then discuss treatment options. The patient report can also be shared with the child’s school to help coordinate a treatment plan for parents, teachers, and school nurses, as appropriate.
“There is a pressing clinical need in psychiatry and behavioral medicine for new, objective approaches to the diagnosis of conditions like ADHD. Often a behavioral diagnosis is complicated by multiple confounding conditions that make it challenging for even the best clinician to establish a diagnosis,” said Calvin R. Sumner, M.D., chief medical officer and senior vice president of clinical development of BioBDx. “The new Quotient™ ADHD System helps clinicians promptly and accurately diagnose ADHD, which has the potential to improve the level of care available to children and their families.”
About the Quotient™ ADHD System
The Quotient™ ADHD System objectively and quantitatively measures the three core symptoms of ADHD (inattention, hyperactivity and impulsivity), gauging a patient’s ability to sit still and pay attention to a defined task, under controlled conditions that replicate a classroom or workplace environment. The data generated by the Quotient™ ADHD System directly correlates to brain function as determined by functional magnetic resonance imaging (MRI).
The Quotient™ ADHD System utilizes two high-resolution infrared motion analysis systems to track head movements in children (and head plus lower extremity movement in adolescents) while they perform a monotonous but demanding novel Go/No-Go performance task. Measurements are taken 50 times per second. The technology that underlies the Quotient™ ADHD System has consistently demonstrated the ability to accurately measure the degree to which a person is able to inhibit motor activity, attend to a visual motor task and respond to the task appropriately without excessive impulsivity.
By design, the capabilities measured by the Quotient™ ADHD System coincide with the areas of deficit manifest in the triad of symptoms characteristic of ADHD (hyperactivity, inattention and impulsivity). Deficits in the capacity to control motor activity, attend to a task, and respond without impulsivity appear to be the result of inefficient and ineffective neurological processing. The Quotient™ ADHD System measures directly and objectively the same neurological control processes that are assessed subjectively in the clinical evaluation of the symptoms of ADHD.
The U.S. Food and Drug Administration (FDA) has cleared this product for marketing in the United States through a 510(k) pre-market notification. FDA clearance of a 510(k) pre-market notification does not denote “official approval,” but it does permit the product's sale in the United States.
The Quotient™ ADHD System is the first advanced, commercially available system based on technology developed at the McLean Hospital, the largest psychiatric facility of Harvard Medical School, an affiliate of Massachusetts General Hospital and a member of the Partners Health Care System. The Quotient™ ADHD System was co-developed by BioBDx and its inventor Martin Teicher, M.D., Ph.D. Dr. Teicher is an associate professor of psychiatry at Harvard Medical School, and Director of the Developmental Biopsychiatry Research Program at McLean Hospital, Belmont, Mass.
About BioBehavioral Diagnostics Company (BioBDx)
BioBehavioral Diagnostics Company (BioBDx) is a privately held company whose mission is to develop, manufacture, and market proprietary systems for the quantitative assessment of behavioral disorders. The company’s lead product, the Quotient™ ADHD System, is designed to enable physicians to accurately make office-based diagnoses for ADHD, ensuring prompt and appropriate treatment. For more information on BioBDx, please visit http://www.biobdx.com/.
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For information contact:
Courtney Harris
Feinstein Kean Healthcare
617-577-8110
courtney.harris@fkhealth.com
