The company developed NeuroKaire using microscopy, sequencing and clinical data from MDD patients and applying advanced AI and machine learning techniques, and intends to team up with physicians and hospitals
NeuroKaire Kit for Major Depressive Disorder. (Credit: PRNewswire/Genetika+)
Genetika+ has received the CE-IVD mark for NeuroKaire, a simple blood test that aids physicians in prescribing optimal treatment for major depressive disorder (MDD).
The Israeli company developed NeuroKaire using microscopy, sequencing and clinical data from MDD patients and applying advanced AI and machine learning techniques.
Also, Genetika+ is planning to team up with physicians and hospitals to implement its NeuroKaire solution in its routine clinical practice.
The CE mark for NeuroKaire is supported by results from a multi-site study, in which the test showed superior accuracy in predicting drug response for patients with MDD.
The clinical study followed patients who received treatment with antidepressants for 12 weeks, including drug switches and response recording.
Results from the study validate the efficacy of NeuroKaire and support its adoption as an essential tool for patients suffering from MDD, said Genetika+.
Genetika+ CEO and co-founder 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.”
Established in 2018, Genetika+ is engaged in developing personalised medicine solutions to optimise treatment for psychiatric and neurological diseases.
It offers precision medicine for mental health, using AI-driven biomarkers from its ‘brain-in-a-dish’ platform, which combines pharmacogenetics and clinical data.
The platform leverages patented technology to rapidly test more than 70 approved antidepressants and drug combinations against individual unique neurological biomarkers.
It enables rapid treatment, reduced side effects, low dosing, and eliminates arduous trial-and-error treatment protocols and unwanted loss of life, said the company.
Harvard Medical School psychiatry professor Mauricio Fava said: “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.
“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.”