The PreCISE-Rx project is implementing clinical pharmacogenomics at UPMC both to deliver superior, cost-effective patient care and to advance our understanding of how genetic variation affects medication response. PreCISE-Rx brings together multidisciplinary stakeholders to develop best practices in the clinical implementation of pharmacogenomics-guided decision support, genetic testing, and education. After a thorough review of the literature, the team authored clinical policies for clinical-grade testing, genotype interpretation, and drug therapy modification for 14 target genes and has collaborated to modify the electronic health record systems for storage of genetic test results and clinical decision support. Phase I involves testing 1200 patients for common drug metabolism gene variants that predict treatment failure of or adverse reaction to the anti-platelet medication clopidogrel following cardiac catheterization.
Pharmacogenomics clinical implementation
Through the PreCISE-Rx project (CYP2C19 testing for clopidogrel use) we’ve successfully deployed a scalable model for genomics implementation at Pitt/UPMC with the first patient tested in Dec 2015. In 2016, on-site CLIA testing procedures, discrete reporting in both Epic and Cerner, clinical decision support, medication use governance, and operationalizing of the UPMC Clinical Pharmacogenomics Service was achieved. Through early April 2017, nearly 950 UPMC patients have received tailored pharmacotherapy services with research data collection. Working closely with UPMC Clinical Genomics, we expect to turn on the first transactional (in-clinical-workflow) VCF deposit to the UPMC omics data warehouse mid-year.
Analysis of data from PreCISE-Rx
As of April 7, 2017, 945 patients underwent CYP2C19 testing, 274 (29%) carried loss-of-function variants, and 202 (21.4%) had actionable results. Planned 1 year follow-up of the demonstration project completes in Dec 2017.
Genomics education and training
The Test2LearnTM program, employing an innovative, awarding winning educational model using personal genomic testing continues to expand. We trained over 750 undergraduates, medical, pharmacy, nursing, and engineering students as well as practitioners in Pittsburgh and at external universities in 2016.
Philip E. Empey, PharmD, PhD