In basic terms, genetic testing refers to clinical processes used to analyze human protein, DNA and RNA. Such tests are used as a means of detecting gene variants associated with disease, and also in nonclinical applications such as paternity testing (Regulation of genetic tests, 2015). At present, three federal agencies play a role in regulating genetic testing: The Centers for Medicare and Medicaid Services (CMS) is responsible for overseeing clinical laboratories and their technicians; the Federal Trade Commission (FTC) regulates false or misleading advertisements; and the Food and Drug Administration (FDA), in its regulatory role the broadest of the three, regulates the safety and effectiveness of genetic tests when used as medical devices (Regulation of genetic tests, 2015). While the FDA provides oversight concerning the use of genomic information that predicts whether an individual will experience adverse reactions to a particular drug, referred as pharmacogenomics, the agency is also charged with regulating laboratory-developed tests (LDT), essentially pre-packaged, single-purposed test kits used to analyze samples through a single laboratory.
The role that the FDA plays in regulating LDTs primarily has to do with the accuracy of the tests. The agency determines whether an inaccurate test results in under risks to patients and is thus categorized, along with other medical devices, by the level of risk. Class I denotes low risk; Class II refers to moderate risks; and Class III devices pose the greatest risks and are subjected to more intensive FDA scrutiny (Regulation of genetic tests, 2015). Overall, the FDA believes that its oversight pertaining to LDTs does not go far enough, claiming that market forces continually change relationships between commercial laboratories conducting testing and physicians who order tests. The agency also believes that the increasing complexity of genetic testing is also cause for more intense regulatory scrutiny (Regulation of genetic tests, 2015). While the FDA has been noted for being rather slow in approving advanced treatments and medications for catastrophic illnesses such as cancer, it would seem that increased regulatory oversight is warranted in the case of LDTs.

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But the proposed changes have set off a firestorm of disapproval. James Evans and Michael Watson, both geneticists, argue that if the changes are implemented they will be responsible for the closure of laboratories, disrupt innovation and perhaps even limit patient choice (2015, p. E1). However, their primary concern has to do with the emergence of genomic medicines, arguing that regulatory change will clog an already overtaxed staff at the FDA thereby having an unintended effect of “derailing” such long-awaited medicines (Evans & Watson, 2015). While such concerns deserve careful consideration, the scientists may actually be somewhat more concerned with prevailing market forces. While there is no arguing that an efficient network of laboratories needs to be made available to physicians and new genomic medications perhaps should take priority, there still may not be certain things that the commercial market is unwilling, or even incapable of achieving left to its own devices.

The central problem to their argument is that it doesn’t account for the need to construct a central database that houses the information required to better understand the effectiveness of LDTs in relation to genetic variants. Currently, there is no way of understanding this relationship because science has yet to identify the significance of variants as they have been identified through testing. Capturing this data would allow science the opportunity to expand on what is already known about genetic variants, where current data resources only have identified approximately 77, 000 unique variants there remain a wide margin of variants that presently have no known clinical significance (University of Washington Health Sciences/UW Medicine, 2015). It will take the FDA and the federal government to oversee development of such an expanded database and to regulate how the information is parsed once achieved.