NEW YORK (360Dx) – Saladax Biomedical announced today it has submitted a de novo classification request to the US Food and Drug Administration for the MyCare Psychiatry Total Risperidone Assay Kit.
Saladax is asking the FDA review the kit for the total measurement of risperidone to monitor drug levels in order to aid in managing patient adherence and ensure appropriate treatment. The Total Risperidone Assay Kit will be the first of a panel of diagnostic tests in the MyCare Psychiatry line that will also include tests for clozapine; quetiapine; aripiprazole; risperidone; olanzapine; and paliperidone. They have a turnaround time of one hour, according to Saladax.
Five of the tests are currently for sale in Europe. Earlier this year, the MyCare Total Risperidone Assay Kit and MyCare Paliperidone Assay Kit received CE marking.
Last month, Saladax acquired the exclusive patent rights for antipsychotic drug tests from Janssen Pharmaceutica that can be used to determine drug levels in patients undergoing treatment with antipsychotic drugs.