NCCS submitted comments to the Food and Drug Administration (FDA) on the Draft Guidance: Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs).  We support the FDA’s efforts to develop a strong regulatory framework for LDTs and commend the agency for the open and transparent process it has pursued in developing the framework and receiving public comment.

NCCS has for a number of years endorsed FDA oversight of LDTs.  Our longstanding interest in this issue stems from our concerns about the risks that certain LDTs, including those that diagnose genetic causes of cancer, may pose to cancer patients.  If these tests do not accurately diagnose cancer or properly identify a genetic mutation, a patient could be improperly treated.  Whether the result of inaccurate diagnosis is treatment when none is necessary or no treatment when a patient should be treated, the harm to patients could be great. Implementation of the regulatory framework is necessary to address that important gap in quality care.

Significant criticism that has been leveled against the regulatory framework, including the assertions that the proposed oversight will dramatically increase the cost of tests, slow the development of new tests, and even create obstacles to ready access to important diagnostic tests.  However, we anticipate that a well-defined regulatory pathway will encourage new test development by providing more certainty and predictability with regard to marketing approval and also in terms of third-party reimbursement.  Moreover, patients currently suffer serious costs –both financial and otherwise – from tests that do not provide useful and reliable information about their cancer diagnosis and cannot guide evidence-based treatment decision-making.

The risk-based classification of LDTs that FDA has proposed represents a reasonable approach to regulation that balances the need to protect patients and the potential burdens of regulation.  We support the steps that FDA has taken to regulate LDTs, as those steps will help to assure patients that LDTs will be useful in determining the appropriate course of cancer treatment.

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