Personalised medicine solutions developer Genetika+ has obtained a CE-IVD mark for its new blood test, NeuroKaire, to optimise treatment for depression.
The new AI-powered tool is intended to help physicians determine the optimal antidepressant treatment required for major depressive disorder (MDD) patients.
The company stated that the test had been developed following training on data collected from patients with MDD. The data collected brings together microscopy, sequencing as well as clinical data by leveraging advanced AI and machine learning approaches.
Its CE mark comes after the results obtained from a multi-site study.
In the study, NeuroKaire showed high accuracy in predicting drug response in MDD patients.
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Genetika+ said that the multi-site study examined MDD patients treated with antidepressants, including drug switches and response recording, for 12 weeks.
The findings from the trial validate NeuroKaire’s efficacy.
To launch the new tool in regular clinical practice, the company is collaborating with hospitals and physicians.
Genetika+ CEO and Co-founder Dr Talia Cohen Solal said: “This CE-IVD Mark is an important milestone for Genetika+, demonstrating the accuracy and efficacy of this much-needed tool in MDD and facilitating the adoption of NeuroKaire in the European market.
“The results confirm the utility of our brain-in-a-dish technology, reflecting the individual patient’s response to the 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.”
MDD is estimated to affect more than 300 million people globally.