According to the National Prostate Cancer Coalition, 218,890 new cases of prostate cancerwere diagnosed in 2007 and an estimated 27,050American men died from the disease.It is estimated that by 2015, more than 300,000 men will be diagnosed annually. Existing guidelines from the American Urological Association assess patient risk based on information available at diagnosis: biopsy Gleason scores, prostate specific antigen (PSA) levels and clinical stage. However, as more men are diagnosed with lower-risk disease, these subjective parameters are becoming less useful.

 

Annual PSA screening has resulted in more men being caught earlier in the disease process than ever before. As a result, each year approximately 186,000 men with newly diagnosed prostate cancer will be assessed as low or intermediate risk, making it harder to determine which men have aggressive disease and which do not.

 

“Although the majority of prostate cancer cases are detected early and categorized as lower risk, there are a significant number of men within this segment whose tumors will grow aggressively, and jeopardize lives,” said Dr. Vijay Aggarwal, President and Chief Executive Officer of Aureon Laboratories. “It is imperative that physicians have access to better tools that will assess disease severity and identify high-risk patients hidden within these lower-risk groups.”

 

Prostate Px+ is based on the results of a large study utilizing data and samples from a cohort of 1,027 men assembled from the Mayo Clinic, Uppsala University, University of Connecticut and Duke University Medical Center. In validation, Aureon’s predictive model identified twice as many high-risk events in low and intermediate risk patients than the best available method.

 

“Prostate Px+ is the first prognostic test to provide this critical information at diagnosis. This technology represents a new integrated approach known as systems pathology that combines molecular biomarkers, histological and clinical information with advanced mathematics,” said Dr. Ricardo Mesa-Tejada, Vice President of Pathology and Medical Director of Aureon Laboratories. “At the time a man is diagnosed, Prostate Px+ will forecast disease progression after treatment, detect high-risk patients presenting as low risk and undetectable by other methods, reclassify intermediate-risk patients and help identify those with less aggressive disease.

 

“Newly diagnosed men with prostate cancer face difficult choices regarding treatment options, each of which can be curative but all with different side-effects that can negatively impact quality-of-life. The assessment of patient risk at diagnosis is critical to making the most appropriate treatment plans,” added Dr. Mesa-Tejada. “Prostate Px+ will provide integrated and objective information to assist physicians and patients in making more educated and informed treatment decisions.”