Diagnostic Kits/Diagnostics and biomarker development- priming the pipeline
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Phillips, K.a., Van Bebber, S. & Issa, A.M., 2006. Diagnostics and biomarker development: priming the pipeline. Nature reviews. Drug discovery, 5(6), 463-9.
- "pipeline problem" defined as decrease in the rate of introduction of drugs and diagnostics to market in recent years, despite major scientific achievement and investment that might have predicted otherwise.
- NIH Roadmap Initiative and FDA Critical Path Initiative (CPI) emphasize addressing the pipeline problem, mostly for drugs.
- FDA regulates diagnostics kits or systems in interstate commerce
- Centers for Medicare and Medicaid Services (CMS), through the Clinical Laboratory Improvement Amendments (CLIA), oversees laboratory testing services commercially offered at single sites, in-house or "home-brew" tests.
- Reagents for in-house tests can be developed internally or sold commercially to CLIA-approved laboratories as analyte-specific reagents (ASRs).
- ASRs do not generally require full FDA pre-market review (PMA)
- A significant portion of future diagnostic development will occur to support the utility and prescription of particular theraputics. Some pharmaceutical companies directly contract diagnostic companies to develop tests for specific therapeutics.
- "In addition to the regulation and development model, two issues stood out as major reasons for the diagnostic pipeline problem: money, and lack of samples for validating and testing biomarkers."
- The lack of money is complex and has to do with payers (usually insurance companies) not perceiving a net economic benefit from conducting a diagnostic and doctors not perceiving a clinical benefit from ordering the test. Hence, even when a test on the market, there may be little or no demand for it because insurers won't pay for it and doctor's won't recommend it.
- "Availability of samples is considered instrumental to the development (or lack thereof) of diagnostics because an abundance of samples is crucial for determining test performance (analytical validity, clinical validity and clinical utility).
- "Diagnostic development involves an iterative process (for example, performance characteristics are continuously fed back into the design) so that diagnostics can ultimately be shown safe and effective for their intended use, which are the FDA criteria for approval."
selected references:
- Rothstein, M.A., Pharmacogenomics: social, ethical, and clinical dimensions [book]
- information on the regulatory process behind diagnostics (in chap 8?)
- Hoag, H., 2004. Testing new ground. Nature, 429(6992), 682-3.
- Goodman et al. The Value of Diagnostics: Innovation, Adoption and Diffusion Into Health Care. (2005)