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Saladax Biomedical Nabs Health Canada Approval for Five Psychiatry Lab Tests

NEW YORK – Saladax Biomedical announced on Tuesday that five of its MyCare Psychiatry Laboratory Assays received approval from Health Canada for use in patients prescribed six antipsychotic drugs.

The tests monitor patients' blood concentration levels of prescribed drugs, including clozapine, risperidone, paliperidone, aripiprazole, olanzapine, and quetiapine, the company said in a statement. The tests run on chemistry analyzers "already present in most clinical laboratories" and results are available within hours, Bethlehem, Pennsylvania-based Saladax said.

In Canada, the tests are available through HLS Therapeutics, the exclusive Canadian distributor of Saladax's MyCare Psychiatry tests.

Saladax received de novo clearance from the US Food and Drug Administration for its MyCare Psychiatry Clozapine Assay in July and received CE marking in 2019.