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Indiana Organizations Conduct Large Study to Assess PGx Testing Impact in Community Setting

NEW YORK (GenomeWeb) – Several organizations in Indiana are working with Eskenazi Health to study whether pharmacogenetic testing improves patients' health and lowers costs in community settings and for underserved populations.

Eskenazi Health's study announced today will examine if PGx testing to guide therapeutic decisions for 33 drugs for conditions, such as heart disease, diabetes, and hypertension, can help doctors prescribe treatments to which their patients will most likely respond. Dubbed Indiana Genomics Implementation: An Opportunity for the Under Served (INGenious), this is one of three projects within the Implementing Genomics in Practice (IGNITE) program that has a total of $11 million in National Institutes of Health funding.

Eskenazi Health, which provides a variety of healthcare services to residents of Marion County and Central Indiana, announced that the Indiana Institute for Personalized Medicine, the Indiana University School of Medicine, and Regenstrief Institute will also partake in this study in which researchers plan to enroll 6,000 patients. A third of the patients will receive PGx testing to guide therapeutic decisions, while two-thirds of those in the control arm will be followed for outcomes for one year, but not tested.

The study will be led by principal investigators David Flockhart, director of the Indiana Institute for Personalized Medicine, and Paul Dexter, chief medical information officer at Eskenazi Health and a scientist at Regenstrief Institute. Researchers plan to enroll patients who are prescribed one of the 33 medications of interest from the outpatient and inpatient settings, as well as from Eskenazi Health's emergency department.

Patients in the PGx arm will have their blood drawn and analyzed for variations in 16 genes associated with drug response. Unless these patients in the PGx arm receive a second drug during the study period, this is the only engagement they will have with the study, Eskenazi Health said. In the study, researchers will employ Regenstrief Institute's clinical decision support platform and informatics resources.

The aim within INGenious, ultimately, is to assess whether such testing improves health outcomes and lowers wasteful spending within a period of a year. "Scientists will test the utility of [PGx testing]  in a community-based setting, and in rural, underserved, and economically disadvantaged populations, and we need to figure out not only whether using genomics in the clinic can be helpful to patients, but also if it will be cost effective," Flockhart said in a statement. In terms of cost effectiveness, researchers will track whether PGx testing improved hospital and outpatient costs during a 12-month period.