The study will be conducted at the Winnipeg Clinic under the guidance of principal investigator, urologist, Patrick Cho. Samples collected from the study will be tested using recently developed Luminex based assays for both PSP94 and Vitronectin, the two proteins that form the P2V test.
Based on feedback received from the FDA after the company filed a Pre-investigational device exemption application in the fall of 2007, this second pivotal study is designed to focus on men who have a prostate-specific antigen (PSA) score of between 2.5ng/ml and 10ng/ml with a normal digital rectal exam result.
Urine samples will be collected from patients prior to biopsy and will be analyzed by the company using the P2V test which has been internally developed on the Luminex platform. Pathology reports will be obtained from the patient’s biopsies, enabling the company to categorize participants as having prostate cancer or other non-cancerous conditions. This is the first time that the company will assay samples using a clinical grade assay platform.
Christopher Moreau, president and CEO of Miraculins, said: “Our goal with this study is to clearly show that the P2V test will safely reduce the number of men who are currently being selected to undergo a prostate biopsy based on their PSA score alone, only to find out afterwards that they are negative for prostate cancer.”