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Aureon Develops a Molecular Prognostic Dx for Prostate Cancer, Trailing Oncotype

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With Genomic Health's Oncotype Dx breast cancer test blazing a trail in prognostic molecular testing, it couldn't be too long until such assays pop up for other cancer indications.

A little more than a week ago, Aureon began offering its Prostate Px prognostic assay as a service from its CLIA laboratory in Yonkers, NY. The test appears to be the first of its kind in prostate cancer — test results offer a probability for the recurrence of prostate serum antigen and tumor metastasis. With information on the likelihood of metastasis, clinicians can decide how aggressively to treat each tumor.

At present, most techniques that provide a prostate cancer prognosis involve clinical observations or imaging technologies. "We don't really have a competitor in the marketplace that is offering any type of technology to give a prediction of prostate cancer recurrence," said Rob Shovlin, Aureon vice president of sales and marketing, in an interview with Pharmacogenomics Reporter last week.

The test measures 20 protein markers that the company identified as most closely related to prognosis from the scientific literature, and a prognostic score is given on the basis of histological, clinical, and molecular cues, said Jason Alter, director of marketing at Aureon. "We have 94-percent sensitivity for PSA recurrence," he said, while "for people who are going to experience clinical failure, we will detect 89 [percent] of them."

In a biochemical recurrence, PSA begins to rise as long as several years after surgery. A rising PSA level is a sign of residual prostate cancer cells, and it could indicate a metastasis.

Competitor Epigenomics is working on an assay to determine the stage of prostate cancer, while other companies, such as Ciphergen, are working on a test to detect prostate tumors in order to replace the standard prostate serum antigen test.

Aureon also plans to launch a biopsy test later this year that should have "a more significant impact, because it's earlier in the process," Shovlin said. The firm does not plan to submit Prostate Px for clearance with the US Food and Drug Administration, but the company "will have to keep an eye on" the path followed by Genomic Health as it continues its discussions with the agency about whether it should have filed its Oncotype Dx test for pre-market clearance.

According to the American Cancer Society, approximately 234,460 cases of prostate cancer will be diagnosed in 2006. That number is growing due to the aging baby boomer demographic, and might reach 375,000 patients annually by 2025, said Shovlin. The initial prognostic assay is intended to test patients who are among the 90,000 per year that undergo radical prostatectomy, and the biopsy test addresses all new diagnoses, he said.

The company's five-person sales force plans to sell directly to urologists in the Boston-Baltimore corridor for "the next couple months," after which Aureon will add more representatives. By the beginning of 2007, the firm plans to have 30 sales representatives, which it estimates as an appropriately sized force for selling to urologists only, said Shovlin.

At this point there is no tie-in of test results to response to therapy — only likely disease outcomes, said Shovlin. "But as we look at more and more specimens and acquire more and more data, we may be able to give a determination of that off of this test," he added.

Aside from radiation and chemotherapy, therapies for prostate cancer are comprised of drugs that block the action of testosterone, such as the generically available Lupron Depot, which is manufactured by Tap Pharmaceuticals, and AstraZeneca's Casodex and Zoladex. Taxotere, a product of Sanofi Aventis, is the only chemotherapeutic shown to increase the survival of metastatic prostate cancer patients, according to the Prostate Cancer Foundation, but several chemotherapies are currently moving through clinical trials.

— Chris Womack ([email protected])

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