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Clinical Data Launches Pharmacogenetic Test for Clozapine-Induced Agranulocytosis on Schedule

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Clinical Data, Inc. has announced that its PGxHealth™ division, provider of Therapeutic Diagnostics™, has launched a test, PGxPredict:CLOZAPINE™, a pharmacogenetic test designed to aid physicians prescribing or considering prescribing clozapine.

According to the company, this is the first of several tests that it intends to release this year, again demonstrating its ability to develop, validate and commercialize pharmacogenetic tests in the ever-evolving field of pharmacogenetics.

The PGxPredict:CLOZAPINE test will provide information on whether a patient is at Higher or Lower Risk of developing clozapine-induced agranulocytosis (CIA) compared to the untested population.

The test is intended to be used as an adjunct to existing clinical information to aid in determining the risk of developing CIA and in determining the risk-benefit ratio of treatment with clozapine.

“I am excited to have contributed to the development of this test,” said Stanton Gerson, M.D., Shiverick Professor of Hematological Oncology and Director of the Ireland Cancer Center at University Hospitals Case Medical Center.

“It can be used by psychiatrists and hematologists alike in both the ongoing management of patients already being treated with clozapine and in the assessment of patients being considered for clozapine treatment. I am looking forward to this test becoming available as well as to additional refinements through continued research by PGxHealth. It is my hope that this information may lead someday to reduced blood monitoring requirements and broader use of this very effective medication for treating schizophrenia.”

PGxPredict:CLOZAPINE places patients into one of two categories: Higher Risk or Lower Risk, through the analysis of a simple blood sample and the genotyping of two single nucleotide polymorphisms in the gene HLADQB1. This gene has been shown by PGxHealth to be associated with CIA in 2 independent case-control cohorts.

“Today we prescribe to an individual based on what is expected from studies of large heterogenous populations and watch to see how the patient responds,” said Carol Reed, Chief Medical Officer of Clinical Data.

"With PGxPredict tests, doctors can make more informed treatment decisions specific to each patient. Based on the results of this test, physicians will be able to prescribe clozapine with more confidence and patients will have greater comfort that they can take this efficacious drug safely.”