As an organization representing cancer patients across the nation, we strongly believe the Food and Drug Administration (FDA) can and should play a role in the regulation of laboratory developed tests (LDTs).  The increased understanding of the role genetics play in cancer and heart disease has led to progress in the development of medical diagnostic technology to help predict, preempt, and treat disease more effectively.  Molecular tests in particular are increasingly used by patients and their providers in the treatment decision process, including identifying whether or not a particular patient would benefit from a targeted therapy.

As patients and their doctors become more reliant on diagnostic tests to provide this information, it is critical that the tests produce accurate and meaningful results.  Unfortunately, regulatory oversight of molecular tests is not consistent. Self-contained tests are required to undergo FDA pre-market clearance and approval to verify accuracy of the chemical analysis and its implication on patient health. Similar tests created by laboratories for their own internal use, also known as LDTs, are not subject to the same level of review even if the tests claim to perform the same function as FDA approved kits.

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Concerns have been raised that FDA involvement in LDT regulation will impede patient access to innovative tests. However, it is important to note that the FDA has a track record of exercising regulatory flexibility to bring new technologies to patients in a timely manner. For example, in 2013, FDA allowed marketing of four next-generation sequencing (NGS) diagnostic devices, the first-ever clearance of its kind. The FDA developed the expertise and tools to conduct a thorough review and used separate approval pathways to reflect the risk associated with each device. The FDA’s draft guidance on LDT oversight also reflects a commitment to flexibility, given the proposal’s risk-based approach to oversight.

Beyond providing timely access to new products, the FDA can effectively fill current gaps in oversight that have led to uncertainty surrounding the quality of some tests. Under the current system, laboratories are not required to report adverse events tied to the use of LDTs, so it is difficult to quantify harms that patients have experienced.  However, the discoveries of faulty and clinically invalid tests being used in ovarian cancer (OvaSure) and other chronic illnesses such as heart disease (KIF6 testing) highlight examples of inadequate oversight. Apart from these examples, the general lack of publicly-available information about the variety LDTs has raised concerns among many patients and their doctors that not enough is known about the accuracy and reliability of these tests.

Current attempts to undermine the FDA process by including a controversial rider in a House appropriations bill is unwarranted.  As Congress weighs various proposals to reform LDT oversight, we urge lawmakers to recognize that FDA involvement is not a threat to patient access. The FDA has undertaken an extensive process of soliciting public input over the course of the past six years to inform the development of the pending guidance, and their effort to protect patients through tiered oversight should not be arbitrarily blocked. Patients and their providers deserve to have confidence in the results of diagnostic tests, since such tests are often critical to their treatment decisions.

We are aware members of Congress are keenly interested in addressing the issue of uneven oversight, but until and unless Congress passes new legislation that does this, the American Cancer Society Cancer Action Network, along with more than 35 other leading health organizations, firmly believe the FDA is the most appropriate agency to evaluate the validity of these diagnostic tests.


Hansen is President, American Cancer Society Cancer Action Network