Press Releases

In Congressional Testimony, AdvaMed Urges Passage of Diagnostic Regulatory Reform

WASHINGTON, D.C. – Today, Zach Rothstein, Executive Director of AdvaMedDx, testified before the House Energy and Commerce Committee, Subcommittee on Health during a hearing on diagnostic test regulation and FDA’s proposed laboratory developed test (LDT) rule.

In his written testimony, Rothstein urged Congress to pass diagnostic regulatory reform, “The current regulatory framework for diagnostics was established decades ago and has remained fundamentally unchanged despite dramatic advancements in the field.  That is why we have supported, and continue to support, comprehensive legislative reform that would result in a modernized regulatory framework that spurs innovation and access to testing and is applied to all diagnostic tests based on their level of risk.

“We appreciate the interest of members of Congress from both sides of the aisle on this issue in recent years, and the leadership of Reps. Bucshon and DeGette in developing the Verifying Accurate Leading-Edge In Vitro Clinical Test Development (“VALID”) Act.

“Maintaining two very different oversight mechanisms for tests that are used for the same clinical purposes, with the differences in regulatory oversight often opaque to providers and patients, is not favorable for public health.  Moreover, it stifles investment in, and deployment of, IVDs nationwide due to the market dynamics and incentives it fosters.  

“Regulatory certainty is crucial for fostering a favorable environment for innovation.  A unified oversight program would clarify regulatory expectations, reducing the ambiguity that currently hampers investment decisions.  A clear regulatory landscape is instrumental in encouraging innovation of new and improved diagnostic tests.”

Also outlined in his testimony, Rothstein highlighted the key features of a modernized regulatory framework:

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