US FDA grants market authorization. Saladax is advancing personalized medicine by providing psychiatrists with the first commercially available antipsychotic test in the U.S.
Saladax Biomedical Inc., announced that the US FDA has granted their De Novo Request for a rapid blood test that measures clozapine levels in psychiatric patients. It is estimated that schizophrenia affects approximately 3.5 million Americans; for some, the only approved treatment is clozapine. The availability of a fast and effective tool is an important tool to monitor the utilization of clozapine.
Clozapine is the first test in the MyCare Psychiatry line available in the US. The test takes less than ten minutes to run and can positively impact the management of mental health patients. Read more.