A Study of the Impact of Genetic Testing on Clinical Decision Making and Patient Care

The molecular basis of many pharmacogenetic polymorphisms has now been elucidated, with
genetic variations resulting in alteration of expression or function of receptors, enzymes,
and transporters relevant to the safety and efficacy of a medical treatment. Genetics has
been shown to be a significant factor in the variability of responses of medication choices
and doses. With the rapid development of cost-effective high throughput molecular genotyping
methods, pharmacogenetics has become increasingly important because of its potential to
identify patients with increased risk of adverse drug reactions or decreased likelihood of
response at standard dosage of drug. By identifying the genetic risks and the most effective
therapy for an individual patient, clinicians may improve the efficacy of treatment and
decrease the risk of adverse drug events. The addition of pharmacogenetic testing to routine
clinical practice may also be extremely helpful because of the cost reduction associated
with the identification of patients that will not respond to expensive drugs or with the
identification of patients likely to suffer from severe adverse events. There are also
tremendous efforts in the pharmaceutical industry to lower the cost for drug development;
pharmacogenetics may fulfill the need to provide the right drug to the right patient and to
increase the likelihood of success of large phase II and phase III clinical trials.

The purpose of this study is to evaluate how currently available genetic tests are being
implemented in various clinics around the United States, and whether this information
results in benefits to patient care. Patients presenting to clinics with pain,
cardiovascular conditions, Arthritis, Type II Diabetes, and/or Mental Health disorders that
are receiving Proove Bioscience's genetic testing will complete validated questionnaires to
measure specific outcomes related to their treatment at each clinical visit, including
medication efficacy, reduction in adverse drug events, and healthcare utilization.
Physicians will document any changes made to treatment regimens, including adjustments to
medications or non-pharmacological treatments, and any improvements in the outcome measures.
Statistical analysis will be performed to calculate relationships between genotypic and
phenotypic data points collected in this study.

The results of this study will provide a measurable understanding of the medical and
economic value of implementing genetic testing into clinical care. Furthermore, data points
collected will be used to examine novel correlations and associations between single
nucleotide polymorphisms and longitudinal clinical outcome measures.

Inclusion Criteria:

- Provide signed and dated informed consent form

- Willing to comply with all study procedures and be available for the duration of the
study

- Male or Female, at least 18 years of age

- Currently taking or a candidate for medication

- Documented or recent complaint within 90 days with initial date of onset

Exclusion Criteria:

- Severe hepatic or renal disease (where current pharmaceutical dosing is affected
and/or requires adjustment of standard dosing prior to PGx testing)

- Significant diminished mental capacity that is unable to understand the protocol,
surveys and questionnaires; unable to read/write English or Spanish.

- Recent febrile illness that precludes or delays participation by more than 1 month

- Pregnancy or lactation

- Participation in a clinical study that may interfere with participation in this study

- Anything that would place the individual at increased risk or preclude the
individual's full compliance with or completion of the study.