NEW YORK – Saladax Biomedical announced on Tuesday that it has signed a global distribution agreement with Danaher's Beckman Coulter for Saladax's psychiatry laboratory tests.
The firm's MyCare Psychiatry Laboratory Assays run on automated clinical analyzers and measure levels of antipsychotic drugs prescribed to treat patients with serious mental illnesses, including schizophrenia and bipolar disorder.
Financial and other terms of the deal were not disclosed.
"The Beckman Coulter sales and support channels will increase the availability of these much-needed tests," Saladax CEO and Founder Sal Salamone said in a statement. "This is a major step in allowing [healthcare providers] to make reliable assessments by providing timely quantitative insights."
"Beckman Coulter's portfolio of therapeutic drug monitoring assays offers laboratories and diagnostic testing facilities ways to improve patient care by ensuring therapeutic ranges are maintained," Kathleen Orland, Beckman Coulter's senior VP and general manager for clinical chemistry and immunoassays, said in a statement. "Our relationship with Saladax expands access for laboratories and clinicians to antipsychotic drug testing for treatment of psychotic disorders, which is a growing healthcare need."
Bethlehem, Pennsylvania-based Saladax currently offers a rapid test that measures clozapine levels, a drug used to treat schizophrenia. The test received de novo clearance from the US Food and Drug Administration in 2020. It has also received approval from Health Canada for five tests that measure clozapine, risperidone, paliperidone, aripiprazole, olanzapine, and quetiapine.