In the field of cancer diagnostics, early detection through screening programs with highly sensitive and extremely specific cancer diagnostic protocols has supported accurate and appropriate therapy selection. While the incidence of cancer and the deaths due to cancer still remain high, novel cancer molecular diagnostics (CMD) are allowing physicians and pathologists to more accurately diagnose cancers, identify predisposition, and select targeted and individualized therapeutic regimens.
Technological advancement has paved the way for personalized medicine as applied to CMD and therapeutics. The thrust toward biomarker discovery and diagnostic-drug codevelopment has been possible given our ability to mine the changes at the genetic, epigenetic, and proteomic levels. Accordingly, the application of genomic and proteomic technologies has significantly furthered the CMD field. While the traditional pathological examination of cancer remains an essential clinical objective, newer technologies such as microarrays, RT-PCR, mass spectrometric proteomic analyses, and protein chips are taking center stage.
The life cycle for the development of a CMD assay through the different stages of biomarker discovery or identification, assay development and validation, and biomarker qualification typically takes four to five years. This is approximately half the time required to bring a new drug to market.
Given that the process is twice as fast, and is only a fraction of the drug development costs, there is a great incentive for molecular diagnostics companies to innovate and bring new tests to market. This creates a big opportunity for diagnostics companies to reap the benefits of time and cost savings, as well as for investment firms and venture capitalists to generate a quicker return on their investment.
The high value of molecular diagnostics tests on the market make new test development an attractive proposition. The time to market can be further reduced by more than two years with the introduction of subsequent tests based on similar platforms, albeit for different cancer types and sub types. The learning and standardization that occurs during the development of the first test cuts down development time by approximately 40% for the subsequent tests. The biggest value proposition, however, lies in the development of companion diagnostics, or the Dx-Rx model.
Despite the market opportunity for new CMD tests, there are concerns about gaining the support of reimbursement agencies for novel molecular diagnostic tests for cancer. The FDA has issued draft guidelines for the molecular diagnostics industry with regard to tests that fall under the category of in vitro diagnostic multivariate integrating assay (IVDMIA). The compliance issue will certainly force companies to rethink their strategies about bringing tests to market. For existing players, this means adapting to the challenge of going through the FDA for an IVDMIA approval.
The effect of regulation will be less drastic if the FDA allows for some buffer time for companies to establish compliance with the new FDA rules when they are finalized. At the current time, the FDA is expected to publish another set of guidelines, which will then be followed by discussions, finally culminating in drafting of the rules. Pressure from the FDA may significantly alter the dynamics of the CMD industry.
With more than 98% of CMD testing currently occurring through CLIA-certified laboratories, the share of revenue from FDA-approved tests is minimal. The balance is likely to shift in the near future as many tests transition to the FDA-approved segment. Some tests may still remain in the domain of CLIA laboratories depending on the degree of complexity and risks involved.