BETHLEHEM, Pa.--(BUSINESS WIRE)--Saladax Biomedical Inc., a diagnostics company providing kits to test drug blood levels for adherence and personalized dose management, on July 3 submitted a De Novo classification request to the U.S. Food and Drug Administration (FDA) for the MyCare Psychiatry™ Total Risperidone Assay Kit.
The De Novo request was submitted for review for use of total risperidone measurements to monitor drug levels to aid in management of patient adherence and to help ensure appropriate treatment. The Total Risperidone Assay Kit will be the first of a panel of diagnostic tests in the MyCare Psychiatry™ line that will include tests for: clozapine, quetiapine, aripiprazole, risperidone, olanzapine and paliperidone. Five of which are currently available for sale in Europe. The MyCare Psychiatry™ panel of tests addresses a critical, unmet need for quickly identifying levels of antipsychotic drugs in a patient’s body. A one-hour turnaround time is possible in a STAT mode within a laboratory. Rapid testing has the potential to reduce treatment failures and positively impact patient management. Once granted by the FDA, the Total Risperidone Assay Kit will be available for sale in the US.
“We are excited to provide a quantitative adherence drug level test to psychiatrists by submitting this distinctive diagnostic for FDA review,” said Dr. Salvatore J. Salamone, President and CEO of Saladax Biomedical. “A fast and accurate result is key to giving physicians timely information of high medical value to better manage their patients.” With this submission, Saladax achieved an important milestone for the company and for the field of psychiatry. The MyCare Psychiatry line will be the first panel of rapid adherence tests available in psychiatry.
Founded in 2004, Saladax Biomedical, Inc. is a privately held company headquartered as an anchor tenant with Ben Franklin TechVentures® located on Lehigh University’s campus in Bethlehem, PA. Saladax develops novel blood tests that increase the impact of personalized medicine by bringing chemotherapeutic drug monitoring to oncologists and adherence testing to psychiatrists. Saladax believes that truly personalized medicine can only exist when the right drug is given at the right dose. Our diagnostic reagents and kits are distributed worldwide excluding the United States, but this submission paves the way to gain entry into the US market. Saladax is ISO 13485:2003 certified.