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Lawmakers Move to Reform Diagnostic Testing in United States

FDA says Legislation is a ‘Top Priority’ for the Agency

WASHINGTON – U.S. Representatives Larry Bucshon, M.D. (R-Ind.-08) and Diana DeGette (D-Colo.-01) introduced bipartisan legislation today that would create a new framework to verify the accuracy of various medical tests that doctors and patients rely on to make important health decisions. 


The legislation – known as the Verifying Accurate, Leading-edge IVCT Development, or VALID, Act – would modernize the review process for diagnostic testing, clarify the regulatory authority between the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS), and limit duplication between the two agencies by ensuring uniform standards are in place that support innovation, giving Americans the assurance they need to rely on their test results.


“Whether it’s an at-home test for COVID-19 or a cancer screening done in a hospital, diagnostic tests are used by millions of patients every single day in this country to make important health care decisions,” DeGette said. “We have a responsibility to ensure that these tests are as accurate as possible, and that the patients using them can rely on their results.” 


“As a doctor, I know just how critical it is that patients and their doctors have test results that they can rely on. Even the slightest discrepancy can have drastic effects on a patient’s wellbeing. Today, I am proud to join my colleague Representative Diana DeGette in re-introducing the VALID Act to make sure that a safe, accurate, and risk-based framework is in place, that allows leading-edge development and innovation to thrive in our hospitals and laboratories while assuring doctors and patients that their test results are analytically and clinically valid,” said Dr. Bucshon.


Diagnostic tests are an important tool that health care providers across the country often rely on to make, sometimes, difficult decisions about the best course of care and treatment for their patients. The measure introduced Wednesday comes in the wake of several high-profile scandals – including companies such as Theranos – that have led to increased demand among public health officials for greater oversight of diagnostic tests being used to screen patients in the United States.


A 2022 New York Times report found that noninvasive prenatal tests, which are not currently subject to FDA approval, yet are used to screen hundreds of thousands of pregnant women in the U.S. every year to determine whether their fetus has any symptoms associated with possible intellectual disabilities, heart defects, or shortened life spans, were not always accurate. In fact, according to the Times’ analysis, for every 100 positive results reported to patients, 85 were wrong.   


For years, FDA has urged Congress to enact legislation that will both solidify its authority to review such tests and, more importantly, provide the agency the framework and resources it needs to effectively do so. The legislation introduced by DeGette and Bucshon will achieve both those objectives, and FDA said it is a top priority for the agency.


The measure will, among other things, ensure diagnostic and lab tests are evaluated properly by creating a new product category and differentiating them from medical devices. This will give FDA the ability to appropriately review the accuracy and reliability of all diagnostic tests used to screen patients in the U.S., including so-called laboratory-developed tests.   


In addition to giving FDA the authority it needs to oversee the nation’s diagnostic testing, the legislation will create a new system that allows hospitals and laboratories to submit their tests to the agency for review electronically, a move that will increase the efficiency of FDA review processes. 


It will also create a new program to expedite the review of any diagnostic test that’s developed to address a current unmet need for patients, providing patients with access to breakthrough testing capabilities as soon as possible. 


To ensure the legislation doesn’t in any way impede the ability of health care providers to continue treating patients while these reforms are being implemented, the legislation includes a provision that specifically grandfathers in any diagnostic test that’s currently available to patients in the U.S.


A copy of the legislation is available here