FDA 2017 Discussion Paper on Laboratory Developed Tests Download PDF
Proposes future regulatory oversight on LDTs, including a risk-based, phased-in approach, and amends key provisions of the 2014 draft guidance.
Proposes future regulatory oversight on LDTs, including a risk-based, phased-in approach, and amends key provisions of the 2014 draft guidance.
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The Discussion Paper on Laboratory Developed Tests, released by the Food and Drug Administration (FDA), describes a possible approach to expanding FDA oversight of laboratory developed tests (LDTs). An LDT is a type of in vitro diagnostic (IVD). Specifically, it is a clinical test that is designed, manufactured, and used in a single CLIA-certified laboratory, as opposed to a commercially distributed IVD, which is manufactured and sold for use by many laboratories. The FDA has the authority to regulate all IVDs as devices, but has generally limited its oversight on LDTs, exercising enforcement discretion. However, as LDTs have grown in complexity, number, and reach, the FDA is considering expanding its LDT oversight.
The LDT discussion paper provides an overview of extensive comments received from clinical stakeholders, patients, government agencies, and Congress in response to an LDT draft guidance policy issued by the FDA in 2014. Like the draft guidance, the discussion paper proposes a risk-based approach that the FDA might take on LDT oversight. However, in response to stakeholder feedback, the discussion paper significantly scaled back the scope of the draft guidance's proposed oversight.
Key proposals in the FDA’s 2017 discussion paper include:
The paper does not address conventional IVD kits, which are submitted to more stringent oversight.
The LDT discussion paper is not enforceable, does not represent the formal position of the FDA, and is not a substitute for a final FDA guidance. It synthesizes the regulatory dialogue that the FDA and stakeholders have had since 2010 and outlines future regulatory possibilities for LDTs.
Extensive stakeholder feedback on the 2014 draft guidance highlighted the importance of balancing healthcare access to LDTs with a reasonable assurance that such tests are analytically and clinically valid. The paper is meant to “advance the public discussion” by providing “a possible approach to spur further dialogue.”
LDTs, to include a growing number of genetic tests, serve an important role in health care. In recent years, the cost of genetic testing has dropped and the number of genetic tests available to providers and patients has risen, making them an attractive option for healthcare. The term "genetic testing" refers to a number of techniques used to detect an individual’s genetic variants, including tests that analyze human DNA, RNA, and proteins. Detection of variants associated with a specific disease or condition can be used for screening, diagnosis, prognosis, or treatment plan development. Rapid advancements in the field of genomics have enabled scientists to develop tests to assess an individual’s risk of developing a wide range of diseases.
The successful incorporation of genetic tests into clinical practice – a goal of precision medicine – hinges on the ability to offer the test to the public expeditiously. Most genetic tests available are LDTs, and future genome-based diagnostic tests, including genome sequencing tests, are likely to be LDTs. Developing an FDA-reviewed IVD for the entire genome would be difficult given the millions of bases - and therefore analytes - to review. A clear path for the review of clinical validity of genome-based technologies would likely foster advances in precision medicine.
Sara Katsanis, MS is a Duke University instructor in the Duke Initiative for Science & Society. Her research focuses on policies for DNA testing in medicine, law enforcement, and human rights contexts.
Endorsements:
Opposition:
The Discussion Paper on Laboratory Developed Tests was published on January 13, 2017. The purpose of the discussion paper is to “advance the public discussion by providing a possible approach to spur further dialogue.” Beyond this, the FDA has not formally solicited feedback or indicated plans for future LDT-related guidances.
Duke SciPol, “FDA 2017 Discussion Paper on Laboratory Developed Tests” available at http://scipol.duke.edu/content/fda-2017-discussion-paper-laboratory-developed-tests (05/23/2017).