The PreCISE-Rx project is implementing Clinical Pharmacogenomics at UPMC to deliver superior, cost-effective patient care and to advance our understanding of how genetic variation affects medication response. PreCISE-Rx brings together stakeholders across many different disciplines to develop best practices in the implementation pharmacogenomics in the clinic by offering guided decision support, cutting-edge genetic testing, and continued medical education. After a thorough review of the literature, the PreCISE-Rx team issued clinical guidances for clinical-grade testing, interpretating genotypes, and modifying drug therapy regiments for 14 targets. This involved close collaboration with the Electronic Health Record systems, in order to properly and safely store genetic test results and records of clinical decision support cases. In the first project, the PreCISE-Rx Phase I involves testing 1200 patients for common genetic variants of drug-metabolizing genes that predict not only the sucess or failure of a given treatment, but also adverse reactions to the anti-platelet medication Clopidogrel after cardiac catheterization procedures.
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