Summary
The EGAPP working group has produced well researched and documented reommendations for the use of genetic testing in metastatic colorectal cancer, Lynch syndrome, and Breast Cancer. The absence of clearcut positive recommendations for defined testing strategies and methodologies would seem to suggest significant risk for meeting growth targets for products already in this space. In a time of potential for cost containment pressure, the absence of strong affirmative recommendations would provide support for those physicians not wanting to use, or insurers not willing to reimburse, some of the affected testing methods. While these recommendations would appear to provide openings for other entrants on the market, te evaluation indicates the type of scrutiny that new tests will face as they are developed.
Analysis
There is a widespread belief and hope that "personalized" medicine and "companion diagnostics" will produce significant clinical benefits as well as revenues to companies providing these services. However, the scrutiny of such tests is likely to grow, especially in an era of cost containment.
The three studies provided here demonstrate the difficult path that needs to be taken to arrive with a long term successful product. The implications of these studies would appear to have some negative impact on the growth potential of several companies in the area of testing for breast cancer and metastatic colon cancer, and no clear positive path for products in the diagnosis of Lynch syndrome.
