NEW YORK — Saladax Biomedical said today that it has received CE marking for use of its MyCare Insite Clozapine Test by mental health professionals treating and monitoring patients with schizophrenia.
Clinicians prescribe clozapine, an antipsychotic medication, to treat severe schizophrenia symptoms in people who have not responded to other medications.
The MyCare Insite Clozapine Test, a rapid point-of-care assay that uses capillary blood from a finger and runs on the MyCare Insite platform, delivers accurate and precise clozapine blood levels comparable to laboratory results, Saladax said. According to the Bethlehem, Pennsylvania-based company, psychiatrists need immediate information to make informed decisions during a patient visit, and the MyCare Insite Clozapine Test addresses this unmet medical need by providing answers in six minutes.
Clinicians, in consultation with their patients, can better manage their patients by using the results to quickly adjust treatments, the firm said.
In 2018, Saladax announced it had submitted a de novo classification request to the US Food and Drug Administration for its MyCare Psychiatry Total Risperidone Assay Kit.