NEW YORK – Genetika+ has obtained CE-IVD marking for its first drug-matching test focused on major depressive disorder (MDD), the precision medicine startup said Wednesday.
The Israeli company's product, a blood test dubbed NeuroKaire, is ordered by a physician. It predicts a patient's likelihood of responding to various antidepressants by combining patient-reported information about symptoms with pharmacogenetics testing and functional testing based on the patient's blood sample.
The company's CE mark follows results from a multi-site study, in which NeuroKaire successfully predicted drug response for patients with MDD.
"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 Talia Cohen Solal, Genetika+'s CEO and cofounder, in a statement. The company is working with physicians and hospitals to deploy NeuroKaire in clinical care.
Genetika+ was founded in 2018 to improve personalized drug prescribing for psychiatric and neurological diseases. It received €17.5 million ($17.3 million) over the summer from the European Commission's European Innovation Council Accelerator to clinically validate and commercialize NeuroKaire.