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Lawmakers introduce bipartisan legislation to modernize clinical diagnostics

Bipartisan legislation that would modernize the process for bringing molecular diagnostic tests to market was introduced in both chambers of Congress last week. 

The Verifying Accurate, Leading-Edge In Vitro Clinical Test Development (VALID) Act, authored by Reps. Larry Bucshon (R-Ind.), Diana DeGette (D-Colo.), and Sens. Michael Bennet (D-Colo.) and Richard Burr (R-N.C.) was developed with input from a broad cross section of stakeholders, including patient groups, manufacturers, providers and laboratories.

The legislation aims to harmonize disparate regulatory processes between the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) with the goal of applying a modern risk-based regulatory system that continues to bring new, cutting-edge diagnostic and lab developed tests to market while providing important performance assurances to patients and their providers.

The following is a statement from Lisa Lacasse, president of the American Cancer Society Cancer Action Network (ACS CAN):

“For cancer patients and their families, a diagnostic test is often the first step toward a viable treatment plan that can attack cancer at its core. Accurate and reliable diagnostic tests are critical in making the best care decisions for those with a cancer diagnosis, which is why we have been engaged in this issue for years.

“We applaud the bipartisan, bicameral introduction of the VALID Act and the collaborative process that the sponsors have taken in writing this legislation. Comprehensive diagnostic reform will not only improve care delivery in the short term, but will also ensure patients continue to benefit from emerging personalized therapies moving forward. We look forward to continuing to work with the sponsors on this legislation and making this much-needed reform a priority.”

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