Prospective Observational Clinical Study to Evaluate Patient Outcomes Following Pharmacogenetic Testing of Patients Undergoing Elective Surgical Procedures

The incidence of opioid-related adverse drug events can reach as high as 50% in surgical
patients and poor pain management is a significant risk factor for early readmission. In
addition, the rate of non- response to certain analgesics is double in patients who are poor
metabolizers as demonstrated by mutations in both CPY26D alleles. There is a growing body of
literature that indicate that ineffective acute pain management contributes significantly to
the risk of chronic pain syndromes. Genetics and drug interactions can alter both the
pharmacokinetics and pharmacodynamics of a multitude of drug compounds and in turn influence
both the safety and efficacy of selected therapeutic regimens.

Pharmacogenetic-guided therapy selection can enhance patient response by facilitating the
selection of the most appropriate medication at the most effective dose in the shortest
possible time.

In this prospective, observational, single-blind study, the investigators will evaluate the
clinical impact of pharmacogenetics-guided treatment on patient well-being as determined by
post-op pain assessments and the frequency of changes in analgesics predicted by testing
results. Additionally, the impact of PGx-guided treatment on narcotic consumption, time to
mobilization, number of adverse events, length of stay, and re-admission rates compared to
historical data will be evaluated during the duration of the study.

Inclusion Criteria:

- Male or female subjects over the age of 18

- Presenting to the site for a prep-op visit prior to undergoing a major bowel surgery,
major urologic procedure or major ventral hernia repair. The pre-op visit must occur
at least 3 days prior to the surgical procedure.

- Willing and able to comply with study procedures

- Able to provide written informed consent

Exclusion Criteria:

- Unwilling or unable to provide written informed consent and to comply with study
procedures;

- Unwilling or unable to provide buccal swab sample

- History of chronic renal dysfunction, Chronic Kidney Disease (Stage 4 or 5);

- New York Heart Classification >3

- Abnormal hepatic function within the last 2 years (INR >1.2 not attributable to
anticoagulant medications, AST/aspartate aminotransferase or ALT/alanine
aminotransferase >1.5x normal, or suspected cirrhosis);

- History of malabsorption (short gut syndrome);

- Gastric or small bowel surgery less than 3 months prior to study enrollment;