In 2007 there were at least 40 company- and lab-developed cancer tests either already available or very near market. In 2008 and 2009, another 70 or so were developed or very near market. The market for these tests is getting very competitive, and some companies are finding out that even as a service, the test really has to respond to medical needs or the technological norms of routine laboratories. Case in point is Agendia’s MammaPrint breast cancer test for cancer recurrence that has had limited success, and this in spite of having FDA clearance.
Other test services that have been launched include Bio Reference Laboratories’ test for K-ras mutation in the colon, Fujirebio Diagnostic’s HE4 Ovarian Cancer Test, Rosetta Genomics’ miRview meso for mesothelioma, Clarient’s Prostate Gene Expression Profile, Neogenomics Laboratories’ FISH probe service for melanoma, and Acupath Laboratories’ test for bladder cancer genes.
Success in this new test commercialization model may appear serendipitous and a function of being at the right place at the right time. While there is an element of this in the success stories, Kalorama contends it is more a question of successful product development. Success is built on a test that fulfills a perceived unmet need, provides sensitivity and specificity, and has an element of proprietary technology (i.e., cannot be performed easily in a routine laboratory).
In 2009, CLIA-certified laboratories were operated by a diverse range of companies, including Affymetrix, CombiMatrix, deCode Genetics, Diagnocure, Ikonisys, Illumina, Predictive Biosciences, Sequenom, Siemens Diagnostics, and Xceed Molecular. These firms market their tests or technology platforms as commercial products and also offer testing services to other laboratories.
Several companies established CLIA-certified laboratories for cancer testing in 2008 and 2009, including Agendia, Beckman Coulter, bioMerieux, Sequenom and Celera Diagnostics.
We are now at the frontier of the next phase of laboratory medicine. Developments in molecular biology, disease management research, and the unraveling of the human genome will drive changes in the scope and direction of lab medicine. Specificially, advances in molecular biology are expected to lead to exponential growth in the number of tests available. Some 25,000 to 30,000 molecular and protein biomarkers may someday become part of the medical toolbox.