Kalorama Information offers comprehensive analysis of the cancer diagnostics market, including cancer testing services, with The World Market for Cancer Diagnostics, 6th Edition. The free white paper regarding laboratory-developed oncology tests is available here.
The test service model has become a leading strategy for laboratories and even some IVD companies looking to expand their footprint in the cancer diagnostics market. In the leading U.S. market, company-owned test services have long served as a vehicle for the commercialization of advanced and highly complex assays. Reference labs in the United States were the first to launch many groundbreaking tests in the areas of viral load testing, anatomical pathology specialty analyses, and molecular diagnostics. First-generation tests target relatively small target markets where the financial investment for FDA market clearance of a commercial test kit or diagnostic device could far outstrip revenue. Consequently, labs and IVD companies have instead opted to first offer the test as a service from a CLIA-certified facility.