The company is developing a commercial genetic test using this newly validated research, which it expects to launch before the end of the year. Such a test has the potential to expand the use of clozapine and improve its safety profile.
The new test will provide physicians, patients and their families with new, quantifiable information about a patient’s risk for clozapine-induced agranulocytosis (CIA) and should lead to better informed treatment decisions concerning initiating or continuing treatment of schizophrenia with clozapine.
The company said that its researchers continue to work on identifying other biomarkers related to CIA to further improve the predictive power of this and next generation tests. The test may also have utility with other drugs that are associated with inducing the blood disorder.
“The results from the NIMH sponsored study have provided more evidence that clozapine is one of the most effective medications for treating schizophrenia, although its use is limited due to the risk of inducing agranulocytosis,” said Dr John Kane, professor of psychiatry, neurology and neuroscience at The Albert Einstein College of Medicine. “This validation of a genetic marker that helps assess risk of developing clozapine induced agranulocytosis brings us one step closer to someday alleviating the need for continuous blood monitoring for the majority of clozapine treated patients.”