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SureGene Receives IRS Funds, SBIR Matching Grant to Advance PGx of Antipsychotic Drugs

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SureGene has received a $244,500 Therapeutic Discovery Project Tax Credit from the Department of Health and Human Services and the Internal Revenue Service to support the development of a molecular diagnostic that aims to help doctors administer antipsychotic medications to those most likely to benefit.

The company announced this week that it received the grant under the Qualifying Therapeutic Discovery Project, which was created by the Patient Protection and Affordable Care Act of 2010.

The grant will allow SureGene to advance its ongoing work to investigate the validity and utility of SULT4A1 variants in predicting who will benefit from treatment with various schizophrenia and bipolar disorder treatments.

In September, pharmacy-benefit manager Medco and SureGene announced that they would conduct the Relative Effectiveness of Schizophrenia Therapy, or REST, study. In this prospectively designed, 2,000-patient trial, Medco and SureGene plan to research how SULT4A1 variants are linked to the safety and efficacy of quetiapine (AstraZeneca's Seroquel), risperidone (Janssen's Risperdal), olanzapine (Eli Lilly's Zyprexa), and ziprasidone (Pfizer's Geodon) (PGx Reporter 07/25/10).

Also this week, SureGene separately announced that it received an SBIR Phase II matching grant from the Commonwealth of Kentucky. SureGene is based in Louisville. The $365,579 in matching funds follows two previous Kentucky SBIR matching awards in 2008 from the Kentucky Cabinet for Economic Development’s High-tech Pool, the company said.

The grant matches an SBIR Phase II award for the same amount that the National Institute of Mental Health awarded to the company and the National Center for Genome Resources in March.

The matching funds will be used "in part" to support the REST study with Medco. In addition to establishing the clinical utility of the SULT4A1-1 haplotype biomarker and other biomarkers being developed by SureGene, the REST Study will also evaluate whether it is cost effective to incorporate pharmacogenomic tests with SureGene's biomarkers in the standard medical care for mentally ill patients.

"Research already conducted by SureGene suggests that the SULT4A1-1 haplotype may be useful in improving the safe use of antipsychotic drugs by identifying subpopulations of patients with schizophrenia who are more likely to experience drug-related adverse events and variation in clinical response after treatment with specific atypical antipsychotics," the company said in a statement announcing the receipt of the government tax credit.

SureGene said that it plans eventually to submit the results of its pharmacogenomic trials involving antipsychotic drugs to the US Food and Drug Administration to gain further guidance on the clinical utility of the SULT4A1-1 haplotype and other markers.

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