Stakeholders Across Political Spectrum Call for Legislation to Strengthen Diagnostic Test Oversight

Editor’s note: This article was updated on May 17, 2022, to remove a statement about the introduction of the VALID Act by the former president of the American Clinical Laboratory Association. The association has not taken a position on the bill.

For nearly five decades, the Food and Drug Administration has taken a fragmented regulatory approach to its review of in vitro diagnostic tests (known as IVDs), tools that countless patients rely on to identify the presence or risk of many serious conditions, including cancer, diabetes, cardiovascular disease, and more. Although commercially manufactured IVDs are required to meet the agency’s risk-based standards, tests made and used in a single laboratory—known as lab-developed tests (LDTs)—are not. This disjointed framework puts Americans at risk of receiving inaccurate test results, potentially causing them to pursue the wrong treatment or forgo the right one.

The current oversight scheme may have made sense in the 1970s, when Congress first authorized FDA to regulate diagnostics. At that time, LDTs were used for rare diseases and on specific populations for which commercially manufactured tests were unavailable. But since then, the LDT industry has grown by leaps and bounds, rendering the current 45-year-old regulatory framework inadequate when it comes to protecting today’s patients.

Lawmakers across the aisle, along with stakeholders in the fields of public health and patient advocacy as well as in the lab industry, all share the concern that the current oversight system is insufficient. Over the past several months, many have publicly voiced their support for bipartisan legislation, known as the Verifying Accurate Leading-edge IVCT Development (VALID) Act, that would unify regulation of all diagnostic tests—a formidable start to creating a risk-based review system that delivers reliable IVDs for patients.

Below are selected quotations supporting the VALID Act.

Senator Michael Bennet (D-CO)

“We need to make sure all diagnostic developers, in and out of laboratory settings, are held to the same analytical and clinical standards that responsible companies already adhere to. … The VALID Act would hold test developers accountable and protect patients by establishing a new risk-based regulatory process at the FDA that ensures patients and their providers receive safe and accurate information about their health.”

Representative Larry Bucshon (R-IN)

“Congress must provide certainty, and that is what we're trying to accomplish through the bipartisan and bicameral VALID Act. We're working to provide certainty for patients that the results of their tests are clinically accurate and to provide certainty for doctors that the tests they are administering and making health care decisions based on are accurate.”

Patrick Godbey, M.D., president of the College of American Pathologists (CAP)

“[The VALID Act] provides the most viable legislative pathway to reaching a consensus on the oversight of laboratory-developed tests. A legislative approach to oversight of LDTs must leverage existing processes to maintain safe and reliable testing for patients today without stifling innovation of future tests. The CAP looks forward to engaging on the latest version of the VALID Act with the bill’s sponsors, other members of Congress, groups representing patients and other physicians, the U.S. Food and Drug Administration, and the White House as the proposal moves ahead.” 

Jeffrey Shuren, director of the Center for Devices and Radiological Health, Food and Drug Administration

“LDTs play a critically important role in health care and, increasingly, they and tests made by commercial manufacturers are important for making clinical decisions. We have to assure, ultimately, that [tests] work. Those assurances are in place if [they’re] made by a commercial manufacturer [but not] if they’re made by a laboratory. … [H]aving a legislative framework that clarifies an overarching approach to assure that all developers—whether they’re commercial manufacturers or laboratories—are working with FDA, and all of us [are] acting consistently under a modern framework … this is the time to do it, and that could have a big impact on public health.”

Ellen Sigal, founder and chairperson of Friends of Cancer Research

“Critical to the future of diagnostic testing and personalized medicine is the VALID Act, which pushes for diagnostic reforms that are much needed. Patients are our North Star in all we do, and this legislation would ensure patients receive accurate and reliable test results.”

Scott Whitaker, president and CEO of AdvaMed

“The bipartisan VALID Act is an important step toward the long-overdue modernization of the law for all diagnostic tests. It calls for smart reforms that will incentivize and improve the development of the advanced, reliable tests patients depend on, regardless of where those tests were developed.”