Medical Device Link.

EDITOR'S PAGE

This year could witness significant advances and progress in cancer testing. In an article forecasting major business trends and developments for 2006, the Wall Street Journal predicted that the discovery and validation of a greater number of cancer biomarkers could lead to “a revolution in cancer diagnosis.” One cancer researcher is quoted in the article as saying “biomarker medicine is an enormously revealing and important technique, and offers the best hope of eliminating suffering and death from cancer.”

While cancer markers are nothing new and have long been recognized as potentially powerful clinical tools, they have constituted a small portion of the IVD market. According to a report by Kalorama Information (New York), cancer markers generated revenues totaling $500 million in 2003. With a projected annual growth rate of 14%, the market for cancer markers is expected to reach nearly $1 billion in 2008. However, recent developments indicate a greater focus on and interest in improving technologies for early cancer detection. With such increased interest, the cancer diagnostics market could grow even more rapidly.

For example, the National Institutes of Health (NIH; Bethesda, MD) recently launched the Cancer Genome Atlas project. The goal of this project is to identify genetic mutations that cause various types of cancer. The NIH hopes that the findings from this project will eventually lead to more targeted cancer diagnostics.

Another positive development occurred when the National Heritage Insurance Company, the Medicare contractor for California, agreed to provide reimbursement coverage for the Oncotype DX breast cancer test by Genomic Health Inc. (Redwood City, CA). Such a decision shows a recognition by Medicare of the importance of providing reimbursement coverage for early detection cancer tests.

In addition, pharmacogenomics could contribute to increased growth in the cancer diagnostics market. As demonstrated by the Oncotype test, which can also predict a patient’s response to chemotherapy, pharmacogenomic factors should be considered when developing cancer tests, according to industry analysts. With the debilitating side effects of chemotherapy and the steep costs for such therapeutics, developing pharmacogenomic cancer tests would be ideal in order to identify the proper therapies for patients.

The market is ripe for more advanced technologies for diagnosing cancer. IVD manufacturers should take advantage of this opportunity by investing the proper capital, resources, and personnel to develop cancer biomarkers into clinical diagnostics.