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Saladax Biomedical launches clozapine test in the US after FDA grants market authorization

Saladax is advancing personalized medicine by providing psychiatrists with the first commercially available antipsychotic test in the U.S.

July 08, 2020 02:00 PM Eastern Daylight Time

BETHLEHEM, Pa.–(BUSINESS WIRE)–Saladax Biomedical Inc., announced that the FDA has granted their De Novo Request for a rapid blood test that measures clozapine levels in psychiatric patients. This is a milestone in psychiatry as the MyCare™ Psychiatry Clozapine Assay Kit is the only commercial test available in the US for monitoring clozapine levels.

“We are excited to receive FDA Clearance of our clozapine assay. We developed the MyCare Psychiatry line based on extensive research into psychiatrists’ needs. The result is a game-changing test that delivers clinicians access to rapid quantitative blood levels of the psychotherapeutic drugs their patients are on,” said Dr. Salvatore J. Salamone, Founder/CEO. “The MyCare Psychiatry Clozapine Assay Kit is the first of the MyCare line and delivers a fast and accurate result giving physicians timely information of high medical value. 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.”

The market authorization of the clozapine assay comes at an excellent time with the recent publication of the US consensus guidelines by the American Society of Clinical Psychopharmacology. These guidelines underscore the importance of monitoring antipsychotic levels and provide guidance on how to implement testing in everyday practice.

It is estimated that schizophrenia affects approximately 3.5 million Americans, of which 25-30% meet the criteria for treatment resistant schizophrenia (TRS). TRS patients are those that are suffering with schizophrenia and are non-responsive to, or intolerant of, conventional antipsychotic medications. For these patients, the only treatment approved and recommended by the American Psychiatric Association guidelines is clozapine. Other countries prescribe clozapine as much as eight times more than in the US and underutilization of clozapine is a concern to clinicians. The availability of a fast and effective tool, like the Saladax Test, could be an important tool to improve the utilization of clozapine.

Clozapine is the first test in the MyCare Psychiatry line available in the US. The line includes tests for quetiapine, aripiprazole, risperidone, olanzapine and paliperidone. The test takes less than ten minutes to run and can positively impact the management of mental health patients.


Founded in 2004, Saladax Biomedical, Inc. is a privately held company headquartered at Ben Franklin TechVentures® located in Bethlehem, PA.

Saladax develops rapid blood tests for point of care and for laboratory analysers for use in psychiatry and oncology. The Saladax MyCare Psychiatry line provides drug level tests of the most commonly prescribed antipsychotics. Saladax believes that truly personalized medicine can only exist when the right drug is taken at the right dose. Our diagnostic reagent kits are distributed worldwide and are under development for use in the United States. Saladax is ISO 13485:2016 certified.

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Saladax Biomedical, Inc.
Salvatore Salamone, Ph.D., 610-419-6731