Saladax Biomedical Receives FDA De Novo Clearance for Antipsychotic Drug Assay

NEW YORK ─ Saladax Biomedical said on Wednesday that it has received de novo clearance from the US Food and Drug Administration for a rapid blood test that measures clozapine levels in psychiatric patients. The MyCare Psychiatry Clozapine Assay provides results in 10 minutes and gives clinicians access to quantitative blood levels of the psychotherapeutic drug, the firm said.