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Assessing the U.S. Regulatory Landscape for Diagnostic Testing

Decision Resources
December 1, 2011
SKU: DECR6727330

Abstract Table of Contents Related Reports

Countries covered: United States

The FDA is taking an active role in encouraging the development and use of biomarker-based diagnostics by publishing revised updates and draft guidance. Such revisions will become increasingly important as new tests and technologies emerge. However, some recent changes have caused a fair amount of controversy among industry and researchers alike. The ability of regulators and stakeholders to reconcile their differences will be key to the industry's continuing advancement.

Questions Answered

The diagnostics industry no longer consists exclusively of basic disease detection tests and reagents. It has evolved into a producer of sophisticated, high-medical-value tests that provide medical information used in patient management. What events and advances have fueled this growth? What are the anticipated changes that could further grow the industry?
The ability to obtain an individual's genetic information at a reasonable price, and ultimately help to advance genetic testing even further, promises significant potential for the field of genetic testing. What, if any, are some key issues that may pose barriers to the growth of genetic testing? How have the regulatory bodies incorporated genetic tests into their rules and processes?
Genetic testing has traditionally been a service offered by physicians at the point of care. Increasingly, however, developers are marketing these tests directly to patients without the physician intermediary: direct-to-consumer (DTC) genetic testing. How is this practice perceived by researchers? What do the proponents and opponents of DTC have to say about the availability and regulation of such tests?
There is little coordination between the regulatory agencies-FDA and CMS-when it comes to review of diagnostic tests; some researchers believe the lack of synergy hinders both the advancement of potential benefits and patient protection. What attempts have been made to reconcile the controversies? How can professional associations advance the mandates of regulatory agencies?

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Assessing the U.S. Regulatory Landscape for Diagnostic Testing

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