Senators Bennet, Hatch & Reps. Bucshon, DeGette Release Draft Legislation to Modernize FDA Regulation of Diagnostic Tests

Washington, D.C. — U.S. Senators Michael Bennet (D-CO) and Orrin Hatch (R-UT), members of the Senate Committee on Health, Education, Labor, and Pensions (HELP), with U.S. Representatives Larry Bucshon, M.D. (R-IN) and Diana DeGette (D-CO), members of the House Committee on Energy and Commerce, today released draft legislation to establish a framework for overseeing in vitro clinical tests (IVCTs), such as test kits and laboratory developed tests (LDTs), at the Food and Drug Administration (FDA). This Congress, the lawmakers have worked with the stakeholder community and FDA to define parameters for IVCT oversight.

“In the age of precision medicine, diagnostic and genetic tests are increasingly part of routine medical care,” Bennet said. “Without safety measures in place, these tests threaten patient safety and the potential of innovative diagnostics to transform health care. We’ll continue working to develop a regulatory framework that results in better government and keeps pace with developing technologies.”

“While I am disappointed this bill will not pass this year, I am hopeful that my colleagues will prioritize this legislation in the 116th Congress,” Hatch said. “Americans deserve the assurance that the tests which are utilized in making vital, sometimes life-or-death, decisions, are both accurate and reliable. This bill establishes a sensible, risk-based approach towards regulation of IVCTs that protects innovation in an ever-changing sector of healthcare.”

“Advanced diagnostics are transforming the way we provide care for patients in the 21st century, giving rise to precision medicine and enabling physicians to provide more individualized treatments for patients,” Bucshon said. “Unfortunately, the regulatory framework for diagnostic testing has become outdated and is still stuck in the 20th century. Our goal with this draft legislation is to ensure patients can get the most appropriate treatment for their disease by creating a new regulatory framework that is risk based, creates a level-playing field, allows for leading edge development to thrive, and assures doctors and patients that their test results are valid and clinically meaningful.”

“Safety and accuracy are rightly our top priorities when establishing a new regulatory framework for the approval and regulation of LDTs and IVCTs,” DeGette said. “I am grateful for the committed partnership of Rep. Bucshon, the Energy and Commerce Committee and our Senate colleagues by working together to forge this bipartisan and bicameral proposal.”

Background on In Vitro Clinical Tests

In vitro clinical tests (IVCTs) are used to analyze human samples, such as blood or tissue. The test results are often used to make diagnosis or treatment decisions. For example, at-home glucose tests can be used to monitor diabetes based on blood sugar levels. One subset of IVCTs are Laboratory Developed Tests (LDTs) that are administered and interpreted by physicians, pathologists, or other clinical professionals in a health care facility. Another subset of IVCTs are related to personalized and precision medicine, such as genetic tests. Health care professionals then use companion diagnostics to determine the optimal drug or treatment at the right dose and time for a specific patient.

Under the Clinical Laboratory Improvement Amendments (CLIA), the Centers for Medicare and Medicaid Services (CMS) is required to ensure quality laboratory operations for LDTs. However, CMS is not required to ensure analytical and clinical validity—in other words, safety and effectiveness—for any IVCTs. Several IVCTs have voluntarily pursued FDA approval under the existing device regulation framework, but current device regulation is not practical for many of the clinical laboratories that develop IVCTs. In order to ensure patient safety and accurate and reliable testing, there is a need for a regulatory pathway for IVCTs.

FDA Commissioner Scott Gottlieb has called for “comprehensive legislation” for IVCT oversight. 

Summary of the Verifying Accurate, Leading-edge IVCT Development (VALID) Act

The draft legislation would establish a risk-based approach to IVCT regulation, prioritizing FDA resources for the highest-risk tests that expose patients to serious or irreversible harm. The legislation also would establish a precertification program for lower-risk tests that are not otherwise required to go through premarket review. Precertification would allow FDA to establish standard validity requirements, while also lowering the burden on labs and developers and protecting continued innovation. High-risk tests, such as novel tests, would be required to undergo premarket review to verify analytical and clinical validity. FDA could require that any test undergo premarket review after providing the developer an opportunity to address issues identified by the agency. 

A copy of the discussion draft is available HERE.