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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.

"When used in conjunction with other laboratory and clinical information, this test can aid in the management of individuals prescribed clozapine for treatment-resistant schizophrenia," Salvatore Salamone, founder and CEO of Saladax, said in a statement.

Bethlehem, Pennsylvania-based Saladax said the MyCare Psychiatry Clozapine Assay is the first test in its MyCare psychiatry line to be available in the US.

In 2019, the firm received CE marking for use of its MyCare Insite Clozapine Test by mental-health professionals treating and monitoring patients with schizophrenia.