Genomic Health Test Aims To Cut Overtreatment of Prostate Cancer

5/8/13Follow @xconomy

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its clinical data to insurance companies to convince them the prostate test is worth the money. And there’s another potential barrier to adoption. A year ago, the U.S. Preventive Services Task Force released new guidelines to physicians which urged doctors to stop doing routine PSA tests to screen for prostate cancer, noting that it often leads to “false positive” tests that lead to overtreatment. So if fewer men get PSA screening tests, fewer men will likely be diagnosed with prostate cancer, and fewer men will have a reason to get a biopsy they can send off for sophisticated analysis by Genomic Health.

David Miller, the president of Biotech Stock Research in Seattle, said he sees a number of reasons why Genomic Health could be in for an uphill battle with its new test. Miller covers several prostate cancer drugmakers, and attended the American Urological Association’s meeting.

“I think this sort of test is critical to urology, but expense is a barrier,” Miller says. “The new PSA guidelines, IF they are actually followed, will make this test less useful since more men will present with advanced disease unsuitable for active surveillance.

Given the AUA’s new guidance, the business case for this test depends largely depends on how many urologists and primary care physicians choose to ignore the AUA’s guidance.

My guess is most urologists and a minority of primary care physicians will ignore the guidance. The test’s success revolves around whether payors — especially those connected with ACOs — will reimburse and/or incorporate it into reimbursement decisions.”

Tycho Peterson, an analyst with JP Morgan who covers Genomic Health and rates it “neutral,” said he’s not expecting big things right away from the new prostate test. “While we remain intrigued at the long-term possibility of a prostate assay, we believe that the test will take longer to contribute to Genomic Health profit than is generally believed,” Peterson wrote in a note to clients on May 2.

Genomic Health also will have to deal with competitive pressure. The Myriad Genetics test, called Prolaris, is based on a 46-gene signature, which it says has been tested in 3,000 patients and is “the only commercial product that predicts prostate cancer death.”

Shak notes that the Genomic Health test is different than Myriad’s in a couple key technical respects. One is that Genomic Health performed its tests in patients who are still early in the diagnostic journey, because they haven’t yet had a radical prostatectomy. The Genomic Health test also looks at a different set of genes from four distinct biological pathways, not one, like Myriad’s. Genomic Health’s internal R&D found that its test was more predictive when it focused on four pathways, Shak says.

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    The study, performed in collaboration with leading prostate cancer researchers at the University of California, San Francisco (UCSF), met its primary endpoint by demonstrating that the multi-gene Oncotype DX®
    Genomic Prostate Score (GPS), assessed in prostate needle biopsy tumor
    tissue, has been prospectively validated as a predictor of adverse
    pathology for patients with early-stage prostate cancer. UCSF and Genomic Health
    plan to submit complete data from this study for presentation at the
    2013 ASCO Genitourinary Cancers Symposium in February. Based on these
    results, Genomic Health is completing the necessary work in its Clinical Reference Laboratory to make the Oncotype DX prostate cancer test available to physicians and patients in the first half of 2013.