Clinical Evaluation of the 'ExoDx Prostate IntelliScore' (EPI)

Primary Objective(s)

- Confirm performance of the ExoDx Prostate (IntelliScore) (EPI) utilizing a designated
collection vessel for men presenting for their initial prostate biopsy with an elevated
Prostate-specific antigen (2-10 ng/mL).

- Evaluate impact of the confirmed ExoDx Prostate (IntelliScore) on the decision to
perform an initial prostate biopsy for men presenting with an elevated Prostate-specific
antigen (2-10 ng/mL).

Secondary and Exploratory Objectives

- Assess physician satisfaction with the ExoIntelliScore Prostate report including test
result presentation, graphics and interpretation.

- Assess patient satisfaction for ease of understanding test results and role on decision
process to have a biopsy.

- Determine the medical economic impact of the ExoIntelliScore Prostate in the prostate
biopsy decision process.

- Correlation of the ExoIntelliScore Prostate score with the actual biopsy result.

Inclusion Criteria:

- 50 years of age

- Clinical suspicion for prostate cancer

- Elevated Prostate-specific antigen between: 2.0 - 10 ng/ mL

- No clinical history of a prior negative biopsy

Exclusion Criteria:

- History of prior prostate biopsy.

- Use of medications or hormones that are known to affect serum Prostate-specific
antigen levels within 3-6 months of study enrollment.

- Clinical symptoms of urinary tract infection (including prostatitis) at the time of
enrollment.

- History of prostate cancer.

- History of invasive treatments for benign prostatic hypertrophy (Benign Prostatic
Hyperplasia) or lower urinary track symptoms within 6 months of study enrollment.

- No known hepatitis (all types) and/or HIV documented in patient's medical record.

- Patients with history of concurrent renal/bladder tumors.