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SureGene, PGXL Partner on PGx Test for Antipsychotic Drugs

This article has been updated to include information about a competing product in the market.

NEW YORK (GenomeWeb News) – Psychiatric molecular diagnostic firm SureGene today announced it is partnering with PGXL Laboratories to launch a five-gene test for determining which patients may be best candidates for the most widely used antipsychotics and antidepressants.

The two University of Louisville spinouts will co-promote the test, called the SureGene Test for Antipsychotic and Antidepressant Response, or STA2R. SureGene is working with healthcare providers to market the test, while PGXL will do so through its own distribution network.

STA2R comprises five genes including SULT4A1-1. In clinical studies, Caucasian schizophrenic patients with the genetic signature who were treated with olanzapine showed reduced psychotic symptoms, SureGene said, adding that SULT4A1-1 positive patients treated with the drug also had a "significantly" lower risk of being hospitalized.

In addition, the test was able to help identify those patients for whom risperidone, the current standard treatment in psychotic symptoms, is contraindicated, as well as patients who may not respond to certain antidepressants.

SureGene discovered and patented SULT4A1-1, and PGXL independently developed STA2R. The test consists of a cheek swab that is performed in a provider's office and then sent to PGXL. The CLIA-certified laboratory headquartered in Louisville, Ky., will perform an analysis and send a report to the clinician.

The deal is the first between SureGene, also based in Louisville, and PGXL. Financial and other terms of the deal were not disclosed.

"STA2R represents a revolutionary change to the treatment of schizophrenia and bipolar disorder," Bill Massey, president and CEO of SureGene, said in a statement. "For the first time, physicians will have a test that can help them prioritize the treatment choices for their patients."

However, SureGene isn't the only firm offering a pharmacogenomic test for such drug response. AssureRx Health, a Cincinnati-based personalized medicine company, offers the GeneSightRx pharmacogenetic testing program for psychotropic drugs. Its test includes a panel of 32 medications, 20 of which are antidepressants and 12 are antipsychotics.