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

By May 1, 2020No Comments

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

Bethlehem, PA – May 1, 2020 – Saladax Biomedical Inc., today 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 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.  “We are excited to receive FDA Clearance of our clozapine assay. The MyCare Psychiatry Clozapine Assay Kit is the first of the MyCare line that 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.”

It is estimated that schizophrenia affects 1% of the population, approximately 3.5 million Americans, and 25-30% of patients with schizophrenia, approximately 875,000, meet the criteria for treatment resistant schizophrenia (TRS). TRS patients are those that are suffering with schizophrenia and are unfortunately non-responsive to, or intolerant of, conventional antipsychotic medications. For these patients, the only treatment that is approved and recommended by the American Psychiatric Association guidelines is clozapine. In other countries, clozapine is prescribed as much as 8 times more than in the US. Underutilization of clozapine is a concern to many. The availability of a fast and effective tool, like the Saladax MyCare Psychiatry Clozapine Assay Kit 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 MyCare Psychiatry panel of tests addresses a critical, unmet need for quickly identifying levels of antipsychotic drugs in a patient’s body. The test is automated on random access clinical analysers and takes less than ten minutes so that laboratories could provide results almost immediately. Rapid testing has the potential to enable clinicians to positively impact patient management.


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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