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Genetika+ Announces CE Mark for NeuroKaire™ its AI-powered Tool to Optimize Depression Treatment

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Genetika+, a company bringing precision medicine to the brain, today announced CE-IVD mark for NeuroKaire, a simple blood test to support physicians in prescribing the optimal antidepressant for their patients. NeuroKaire is designed to assist physicians in determining the optimal antidepressant treatment for patients with Major Depressive Disorder (MDD). Genetika+ is partnering with physicians and hospitals to implement the tool in routine clinical practice.

Genetika+ is pioneering precision medicine in mental health through proprietary AI-driven biomarkers from their “brain-in-a-dish” platform uniquely combined with pharmacogenetics and clinical data. NeuroKaire is the result of training on data from MDD patients combining microscopy, sequencing and clinical data using state-of-the art AI and machine learning techniques.

The CE mark follows pioneering results on data from a multi-site study in which NeuroKaire demonstrated unprecedented accuracy in predicting drug response for patients with MDD. The study followed patients treated with antidepressants for 12 weeks including drug switches and response recording. These results validate the efficacy of NeuroKaire and support its adoption as a much-needed tool for patients suffering from MDD.

MDD is a debilitating disease affecting over 300M people globally. Despite a vast array of treatment options on the market, individual response to drugs varies significantly and the majority of patients undergo multiple drug iterations over extended time periods before finding the right drug for them. With well-documented side-effects associated with various drugs used to treat MDD and significant healthcare costs associated with suboptimal disease management in depression, there is significant unmet need for a product like NeuroKaire.

“Psychiatrists seeing MDD patients have long been awaiting a tool to help guide their choice of antidepressant, in particular given the large percentage of patients that do not respond to their first line medication,” said Professor Mauricio Fava, Professor of Psychiatry at Harvard Medical School and Psychiatrist-in-Chief at Massachusetts General Hospital. “Implementing precision medicine in a debilitating disease such as MDD is a key goal for both the physician and the patient community. We look forward to innovative technologies that could offer actionable insights in the field.”

“This CE-IVD Mark is an important milestone for Genetika+, demonstrating the accuracy and efficacy of this much needed tool in MDD and facilitating adoption of NeuroKaire in the European market,” said Dr. Talia Cohen Solal, Genetika+’s CEO and Co-founder. “The results confirm the utility of our brain-in-a-dish technology, reflecting the individual patient’s response to drug in the target organ. MDD prevalence is continuously on the rise, exacerbated by the COVID-19 pandemic and Genetika+ is committed to providing practical solutions that help physicians and patients better manage this devastating disease.”

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Medical Device News Magazine provides breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

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