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On December 9 pharmaceutical firm Genentech filed a citizen petition with the Food and Drug Administration (FDA). “Genentech submits the attached Citizen Petition… to request the Commissioner of Food and Drugs require all in vitro diagnostic tests intended for use in drug or biologic decision making be held to the same scientific and regulatory standards,” wrote Genentech Senior Vice President and General Counsel Sean Johnson in a cover letter. “These scientific and regulatory standards should apply regardless of whether the in vitro diagnostic tests are developed and sold by device manufacturers as diagnostic test ‘kits’ or are developed in-house by laboratory-based companies for in-house testing...”

Currently, FDA regulates genetic tests as in vitro diagnostic devices (IVDs, also called "test kits"), if the components of the test are bundled together, labeled for a particular use, and sold to a laboratory as a unit. Such kits must undergo successful premarket review before they may be commercially distributed. In order to receive FDA authorization to sell the kits, companies must submit information to FDA demonstrating that the test is safe and effective.

Most genetic tests, however, are laboratory-developed tests (LDTs), meaning they are assembled by laboratories themselves. FDA regulates a small subset of LDTs that the agency terms in vitro diagnostic multivariate index assays (IVDMIAs). These tests use laboratory data and an algorithm (analytical tool) to generate a result for the purpose of diagnosing, treating, or preventing disease. FDA also claims the authority to regulate all other LDTs, but has so far declined to do so.

Genentech’s petition argues that all diagnostic tests “should be held to the same scientific and regulatory review standards,” that FDA has “statutory and regulatory jurisdiction over all LDTs,” and that the agency should regulate all LDTs and take enforcement actions against companies making unsupported claims about tests.

The Center released a statement in support of the petition, stating, in part, that “if FDA regulates only drugs used as part of personalized medicine, and not the tests used to prescribe such drugs, it is missing half the equation. FDA's episodic and seemingly arbitrary enforcement activities cannot substitute for a coherent and sustained regulatory strategy, especially given the exponential increase in the numbers and types of genetic tests available and the increasing importance of genetic test results in guiding health-care decisions.”

The Center also submitted comments to FDA in support of the petition. “FDA regulation of IVDs and not LDTs has resulted in an uneven playing field that creates a disincentive to perform research to establish clinical validity and deters innovation of new tests with demonstrated validity,” the comments state. “Effective stewardship by FDA is needed to develop and implement a coherent and equitable system of oversight for such tests that is based on the level of risk posed by the test, and does not depend on whether the test is developed as an LDT or an IVD.” – Shawna Williams

Genentech’s Citizen Petition

News release - Statement regarding Genentech citizen petition filed with FDA

Center’s comments to FDA

Graphic – Genetic Testing Oversight

Issue brief – FDA regulation of genetic tests

Article - In Search of a Coherent Framework: Options for FDA Oversight of Genetic Tests

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