Aureon Laboratories Inc, Yonkers, NY, has introduced Prostate Px®+, a commercial test that predicts prostate cancer progression and disease recurrence at the time of diagnosis.

The test is based on the results of a large study using 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, the lab’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 Ricardo Mesa-Tejada, MD, the company’s medical director and VP of pathology. “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.

Annual PSA screening has resulted in more men being caught earlier in the disease process than before, and each year some 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.
According to the National Prostate Cancer Coalition, 218,890 new cases of prostate cancer were diagnosed in 2007, and an estimated 27,050 American 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 (AUA) assess patient risk based on information available at diagnosis: biopsy Gleason scores, prostate-specific antigen (PSA) levels, and clinical stage. As more men are diagnosed with lower-risk disease, the subjective parameters are becoming less useful, say company officials.

“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 Vijay Aggarwal, MD, the company’s president and CEO. “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.”

The company publicized the test at the AUA annual meeting, held from May 17 to 22, 2008 in Orlando, Fla.

Aureon furthers personalized patient care through predictive pathology. Its high-throughput-systems pathology-technology platform helps to predict individual clinical outcomes through the interrogation of tissue. The platform generates and analyzes an integrated, digital view of clinical findings, tissue microanatomy, and tissue molecular pathology to determine which combination of features predicts specified, individual clinical outcomes. The company is allied with major cancer centers, and operates a CLIA-certified and CAP-accredited lab.