AUGUSTA, Ga., July 22, 2013 /PRNewswire/ -- NEBA Health, LLC releases today key study results regarding the FDA approval of NEBA®, the first brain wave test to help clinicians assess ADHD in children and adolescents. FDA cleared NEBA for marketing on July 15, 2013.
NEBA integrates an ADHD biomarker together with a clinician's ADHD evaluation. In other words, NEBA is not used as a stand-alone diagnostic. The clinician still conducts their ADHD evaluation as in their regular practice using their usual assessment tools. Once the clinician determines that ADHD-like symptoms are present, NEBA helps the clinician to determine whether the symptoms are due to ADHD, or due to another condition. NEBA does this using EEG to separate ADHD patients into biomarker-based groups with clinical differences that allow validated recommendations to be offered to the clinicians.
Because ADHD symptoms overlap with other diagnoses, there may be difficulty for the clinician to determine whether ADHD is the primary cause, whether ADHD symptoms are secondary to other diagnoses, or whether ADHD is comorbid with other diagnoses. Dr. Steve Snyder, Vice President of Research and Development said, "NEBA can help the clinician to confirm ADHD as primary diagnosis, and can help the clinician to determine whether ADHD-like symptoms may be better explained by another primary condition."
About NEBA accuracy
Previous studies have supported that a multidisciplinary team of clinicians is better able than an individual clinician to determine if ADHD-like symptoms are due to another primary condition. Similarly in the NEBA Clinical Investigation reviewed by the FDA, a triple-blinded protocol showed only 61% agreement between individual clinicians and a multidisciplinary team. The investigation also showed that a clinician could use NEBA to improve accuracy from 61% to 88%. (Study results are posted at http://www.nebahealth.com/results.htm)
Dr. Snyder said, "Our study supports that a clinician using NEBA as one part of a full ADHD evaluation would be more likely to converge upon diagnostic evaluation results of a multidisciplinary team."
About NEBA costs
Using NEBA will lead to cost savings. Dr. Snyder said, "Whereas NEBA adds some upfront costs, it does reduce overall costs in the long term by significantly reducing misdiagnosis." NIH/HHS awarded the company a Qualifying Therapeutic Discovery Project grant in October of 2010 based in part on NEBA's potential to be cost saving.
Howard Merry, President, said, "Introducing NEBA in the United States is the culmination of seven years of dedicated work with FDA and follows our CE marking in Europe and Health Canada licensing. Our small team has been together for the entire duration of this project and we are committed to helping clinicians, children, and families."
About NEBA Health
NEBA Health is focused on Neuropsychiatric Interpretive EEG Assessment Aids. We have ongoing work in ADHD, depression and dementia. Our first product - eponymously named NEBA - is an ADHD assessment aid cleared for marketing in the USA (K112711), as well as CE marked and Health Canada licensed.
|SOURCE NEBA Health, LLC|
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