October 22, 2011

Turf Battles in the Regulation of Genetic Testing

The uneven regulation of genetic testing in the U.S. – where most genetic tests are laboratory-developed tests (LDTs), meaning that they are offered as services, rather than products - has meant that many genetic tests are not regulated, in contrast to a retailed medical testing kit (e.g., diabetes test) fully regulated by the FDA as an in vitro diagnostic. The FDA has moved to utilize (effectively expand) its enforcement discretion by issuing guidelines for companion diagnostic tests (genetic testing accompanying the use of a pharmaceutical, e.g., Herceptin) as well as some direct to consumer genetic tests. While the FDA has increased its oversight over these sectors of the genetic testing field, there are other legislative moves that would actually keep the regulation of such tests at the Center for Medicare Services (CMS), the agency that enforces Clinical Laboratory Improvement Amendments (CLIA), which generally regulates laboratory testing in the U.S. A new bill has been introduced – HR 3207 - which would authorize CMS to establish a review and notification process for LDTs – specifically, to review such test for clinical validity- a key phrase in the trilogy of laboratory testing parameters – analytic validity, clinical validity and clinical utility – the upshot is a deeper look into whether a test has a verifiable relationship to the clinical care that is supposed to be supported with the use of the test. So this new bill, supported by industry trade groups, such as the American Clinical Laboratory Association (ACLA) would place this authority at CMS. Would the FDA still have a role to play?  Not clear; what this bill signals is that the slowly evolving regulatory landscape is unstable enough that the leading actors are still to be decided. Of course, the genetic testing industry will not welcome any redundancy of effort (nor should we, as taxpayers). What may finally issue could depend on the finances - that is, in a climate where expenditures dictate policy, the largely unfunded mandate that HR 3207 generates for CMS could fare better against new authorities for the FDA which might be expected to require additional funding. The new bill would have CMS create a registry and require premarket notification (not approval) for LDTs. A genetic test registry is also being created by NIH, to be launched in 2012.

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