Implications of new breast cancer prognostic methodology

Implications: Approval of the Mammaprint is a significant advance clinically, as it is the first FDA approved gene expression test for breast cancer.  If it is widely accepted, it would represent one of the highest value cancer diagnostic products.  The technology would presumably be extended to other common cancers as well.

The Mammaprint is not yet available in the United States, and enters a market with one significant competitor, Oncotype DX.  The latter test is not yet FDA approved, which all things being equal, would put it at a disadvantage for some payers.

From the point of view of the laboratory diagnostic market, this product, and similar ones, have the effect of cutting out a layer of middleman, and thus retaining all profits within the company with rights to the test.  As opposed to the vast majority of lab testing in this country, which is done in commercial or non-profit laboratories, using reagents and instrumentation purchased from manufacturers, this test will presumably be performed as a service in a single location by the company or licensee. 

Analysis: This product has tremendous potential importance, both in the management of breast cancer but for the entire diagnostics industry.

1) Clinically, the test appears to have significant prognostic value in predicting those individuals who have low risk of relapse.  It is not clear however, the clinical implications of such information.  Will women with "low risk" profile truly be spared aggressive therapy on the basis of this test alone? Will individuals that are spared such therapy (and consent to this approach) and do badly be a potential source of failure to treat litigation.?

2) This is potentially a huge market in terms of the clinical diagnostics industry.  With 100,000 new early breast cancers in the US, and a price of $3000 (the competitors price), there is a large potential market.  This product has an advantage, independent of any clinical advantage, that by being FDA approved, some payers may be more inclined to favor this test over others.

3) This test is at the leading edge of the approach to diagnostic testing, whereby the owners of the intellectual property sell a service directly to consumers or their proxy, physicians, rather than selling equipment and reagents to laboratories, who in turn produce results that they sell to the physicians and patients. This is a model pioneered by Myriad Genetics with Brca1, and some other companies in other disease groups.   From the companies point of view, all the value is retained and control of the product, its brand and its reputation is retained as well.  Clinical laboratories may feel threatened by loss of business to a competitor playing by an entirely different set of rules.

4) The lack of multiple users of the product is a source of concern in the laboratory community, in that the company controls all the data, and the feedback from having multiple users of a product is absent.  The regulatory environment that such products will face should be considered fluid, in that current regulatory regimes dependent on multiple users comparing results is not applicable.

5) From a societal point of view, given the ease of communication and transport of samples, there is no reason not to have such testing done for an entire country in a single location.  This changes the general laboratory model, where a single test might be done in hundreds of sites across the country, and the company makes money by placing equipment in these sites.  A much smaller amount of capital equipment can produce a larger amount of results.