Diagnosing prostate cancer is a fairly straightforward process. Assessing the cancer's aggressiveness to prescribe the most effective treatment regimen, however, is very subjective.

Aureon Laboratories (Yonkers, New York) has advanced the use of personalized medicine in this disease state with the launch of Prostate Px+, the first commercial test to predict prostate cancer progression and disease recurrence at the time of diagnosis.

"This is extremely important because prostate cancer is a highly diagnosed condition, but unfortunately 80% of those diagnosed don't need active intervention at the time of diagnosis because they have a slow-growing form of the disease," Vijay Aggarwal, president/CEO of Aureon, told Medical Device Daily. "Our test is helpful in identifying those 80%."

Prostate cancer may be the second-leading cause of cancer-related deaths in men, but if detected early, the survival rate is 100%. Annual prostate-specific antigen (PSA) testing has helped more men to survive, but it also has introduced what's known as risk group compression, meaning doctors know their patients have prostate tumors, but they must subjectively decide how to treat.

Thus, a majority of the diagnosed men are sent for biopsy at an early disease stage. As a result, each year approximately 186,000 men with newly diagnosed prostate cancer will be grouped into low or intermediate risk categories, but many who die of the disease are present in this seemingly innocuous group.

Prostate Px+ provides physicians now with a tool to differentiate the true risk among intermediate-risk patients and to more accurately identify high-risk patients hidden within these lower-risk groups.

American Urological Association (AUA; Linthicum, Maryland) guidelines place patients in risk categories (low, intermediate and high) based on biopsy Gleason scores, PSA levels and clinical stage. But the overall assessment still includes subjective clinical and pathological parameters.

Aureon has been working for six years to develop technology to quantitatively measure biomarkers. Over the last three years, the company has applied those tools primarily to prostate cancer.

"PSA and a biopsy aren't bad tools," Aggarwal said. "The problem is, PSA isn't very specific to assess changes or for tumor aggressiveness. Gleason grading is highly subjective and relies on the ability of the pathologist to make very small differentiations between tumor samples. There's a human error factor there. We find, clinically, that men who have identical PSA and Gleason scores have very different clinical courses. There are limitations of Gleason grading to accurately determine disease aggressiveness."

Prostate Px+ is based on the results of a large study of 1,027 men assembled from the Mayo Clinic (Rochester, Minnesota), Uppsala University (Sweden), University of Connecticut (Storrs, Connecticut) and Duke University Medical Center (Durham, North Carolina).

Aureon's predictive model identified twice as many high-risk events in low- and intermediate-risk patients than the best available method.

The Aureon test uses the same tissue sample retrieved via biopsy and then analyzes on four levels: histologic, molecular analysis, clinical (which takes into account Gleason score, PSA level and clinical stage) and advanced mathematics are used to analyze all of this data to formulate a conclusion.

Urologists receive a report that includes a score – a low of one to a high of 100 – indicating the severity of disease and likelihood of recurrence.

Currently, urologists must have the test done at Aureon''s lab, but within five years, Aggarwal said, the test should be available at other labs.

The company already has executed a license agreement with labs in Spain and Portugal, with plans to expand the network of labs.

At a cost of $3,000 per test, reimbursement is not yet established.

"But as we roll out, we're discussing reimbursement with insurers," Aggarwal said. "We've just begun discussions which are, so far, positive."

Other current applications of the technology include research agreements with Astra Zeneca (London) and Pfizer (New York), both of which are developing prostate cancer therapies.

This is privately held Aureon's first commercialized product and, apparently, a lot of heavyweight investors are betting on the technology.

Venture capital funding has come from Atlas Venture (Waltham, Massachusetts) and New Leaf Venture Partners (New York), Becton Dickinson (Franklin Lakes, New Jersey) and Pfizer, as well as a group of angel investors from Europe.

"Right now it's a difficult environment to raise capital," Aggarwal said. "But we have just closed a Series C financing to give us sufficient capital for the launch.

"We think the era of personalized medicine is going to first make an impact in oncology and that's why we chose it as a focus for our company," Aggarwal said.

"Aureon and companies like ours hold a lead position because patients, physicians, pharmaceutical companies and third-party payers are asking the question, 'If we have drugs that are effective for a small number of patients, who will respond best?' Technology like ours will be key to determining patient response in the treatment of cancer," he said. "We think it's an area that will continue to expand."

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