Predicting the future: what Genomic Health isn’t telling us (yet)


A media release issued  yesterday by Genomic Health, Inc., has suggested that the multi-gene Oncotype DX® Genomic Prostate Score™ is a strong predictor of risk for the development of metastasis and prostate cancer death in patients with early-stage prostate cancer.

Unfortunately, however, the company’s media release provides no information whatsoever about the precise nature of the actual study carried out, where it was carried out, or what the actual results of the study show. The actual media release reads (in part) as follows:

The study, performed in collaboration with a large integrated healthcare system, met its primary endpoint by demonstrating that the multi-gene Oncotype DX® test, assessed in prostate needle biopsy tumor tissue, is a strong predictor of the development of metastasis and prostate cancer death in patients with early-stage prostate cancer. With these new results, the Oncotype DX test becomes the first genomic test validated in all major short- and long-term end points: adverse pathology, biochemical recurrence, metastasis and prostate cancer-specific death.

It then goes on to state that:

The complete data analyses will be submitted for presentations at major urological meetings in 2017.

As careful readers of this news site will be well aware by now, the relative merits of the widening range of gene-based tests that are available for prognosis and monitoring of patients prior to and after initial treatment for early stage prostate cancer are largely unknown because few patients have received more than one of the tests available … and there are no completed trials that allow a patient or his doctors to ascertain whether some of these tests are more accurate than others (or, better yet, that just one of these tests is far superior to all of the others). As a consequence, the developers of the various tests are in an intense competitive battle to win “market share” for their specific product.

When the data promised by Genomic Health are available, we might be able to make a better assessment of just how meaningful these data are. In the meantime, all we really know is that Genomic Health and its research partner at the “large integrated health system” appear to be pleased with the data they have been able to develop. The rest of us will just have to wait to see what they have to show us. And the very earliest that that might start to happen would probably be at the Genitourinary Oncology Symposium in Orlando next February.

5 Responses

  1. I’ve had two of these tests by Genomic Health, as per UCSF Urology, and the results are consistent. Along with other test results, e.g., PSA, %free PSA, biopsy, DRE, the Oncotype results are consistent with the other tests. Perhaps as a “package” of results, we know more … but not omnipotently so. …

  2. Dear gmac53:

    What I had intended to imply was that few men have had more than one of the different types of genomic test done on the same sample material, e.g., having an Oncotype DX test and a Prolaris test and a ConfirmMDx test all done on the same sample material so that one could compare the prognostic accuracy of these different tests.

    Apparently I wasn’t being sufficiently clear.

  3. Phil Febbo, the CMO at Genomic Health, presented to a plenary session of Answer Cancer this past Monday (10/31). The session is available to audit if you click here, and the speaker’s slides are posted for download. Phil speaks for the first 55 minutes, and is followed by a spokesperson from Foundation Medicine.

    I need to listen again — but I am sure Phil addressed this result; there may even be slides.

  4. Rick:

    I listened to the relevant part of the talk and looked at the slides. In the talk Dr. Febbo simply states that they have “some very exciting new data” that they will be presenting in the future, which is what the media release says.

  5. Thanks as ever for doing the spade work Mike — I did recall he mentioned this research but not what he said … evidently no more than the press release. I guess this qualifies for ‘Watch this space!’

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