Oncotype DX prostate cancer test: ready for prime time?

A media release issued yesterday by Genomic Health, Inc. states that its Oncotype DX prostate cancer test has shown positive results in a prospective clinical validation study. Specifically, the company states 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.”

Unfortunately, what we do not have as yet is any data on which to make a specific judgment of the potential of this claim. The media release goes on to state that the company and its collaborators from the University of California, San Francisco (UCSF) rplanning to submit data from this study for presentation at the ASCO Genitourinary Cancers Symposium, scheduled for next February in San Francisco. Until then, we are going to have to take the company at its word.

What we do have, however, are supportive statements from two highly reliable sources.

According to Dr. Peter Carroll, the chairman of the Department of Urology at UCSF:

It is widely recognized that a very large percentage of men with low and intermediate risk prostate cancer are over-treated due in part to the lack of a standardized, validated biopsy-based test to more accurately distinguish between aggressive and clinically indolent disease. These results have the potential to change medical practice significantly by providing physicians and their patients with a multi-gene prostate cancer test, designed specifically for biopsies, that will improve treatment decisions for early-stage prostate cancer at the time of diagnosis.

In addition, Howard Soule, PhD, executive vice president and chief scientific officer for the Prostate Cancer Foundation has stated that:

With this study, Genomic Health has applied its groundbreaking technology and innovative clinical trial expertise to address a critical treatment decision facing hundreds of thousands of men each year.

It is reasonable to take these two statements at face value, which implies that the data that will be presented in February really are “ground-breaking.”

In the meantime, Genomic Health plans to complete work necessary to make the Oncotype DX prostate cancer test available to physicians and patients in the first half of 2013.

The test is based on RT-PCR technology that is used to evaluate the genetic make-up of very small amounts of tissue from prostate cancer biopsy specimens. The company believes that these data, used in combination with other conventional data (such as a patient’s Gleason score, PSA, and age, and other factors)can be used to better personalize prostate cancer treatment based on the underlying biology of an individual patient’s tumor. They also believe that the test will be useful in helping to differentiate accurately between those men who are most suitable for active surveillance and those who are clearly in need of early, aggressive treatment.

The company also acknowledges several years of collaborative effort in conjunction with researchers at the Cleveland Clinic and at UCSF in the development of this new test.

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