Take Stock of the LDT Market Landscape with the New Kalorama Information White Paper

Take Stock of the LDT Market Landscape with the New Kalorama Information White Paper

Kalorama Information offers comprehensive analysis of the cancer diagnostics market, including cancer testing services, withThe 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.

As a faster route to market increasingly taken by clinical labs and the IVD industry, LDTs are under rising scrutiny from the FDA. The agency has chosen to exercise its “enforcement discretion” in recent years, with regulatory handling of LDTs expected to change in the near future.

To learn more regarding companies already in the largest LDT segment or oncology testing services, the size and growth of the cancer LDT market and anticipated changes in U.S. regulation of LDTs, please consult Kalorama Information’s latest white paper Sizing Up the Opportunity in Lab-Developed Tests.