In the News

While championing advances made in diagnostic technology in recent years, top officials from the US Food and Drug Administration (FDA) are calling for a new regulatory framework for in vitro clinical tests (IVCTs) and laboratory developed tests (LDTs).

Background

Since 2013, FDA has attempted to develop a new regulatory framework for LDTs, which are currently regulated under the Clinical Laboratory Improvement Amendments (CLIA) and do not undergo FDA review as in vitro diagnostics do. While FDA’s efforts have been sidetracked and delayed for years, there has been a growing consensus that a new paradigm for regulating clinical diagnostics is needed. In 2017, Reps. Larry Bucshon, M.D. (R-IN) and Diana DeGette (D-CO) circulated a discussion draft known as the Diagnostic Accuracy and Innovation Act (DAIA) to serve as a basis for creating a new regulatory framework for LDTs. However, FDA has suggested changes to the DAIA in technical comments submitted to Congress in August that have sparked some pushback from the American Clinical Laboratory Association.

New Framework In a post to FDA’s website on Thursday, FDA Commissioner Scott Gottlieb, Center for Devices and Radiological Health Director Jeff Shuren and Gottlieb’s Chief of Staff Lauren Silvis explain the need for a new regulatory framework and how they believe it could be shaped. “New tests that undergo rigorous FDA review must demonstrate that they’re analytically and clinically valid. But the majority of laboratory developed tests (LDTs) currently don’t demonstrate to FDA that they meet the same standards,” they write. The officials also say that the current paradigm disincentivizes diagnostic makers from investing in tests that will have to compete with LDTs that do not have to undergo FDA review. “Today, we need a unified approach to the regulation of in vitro clinical tests to protect patient safety, support innovation, and keep pace with the rapidly evolving technology that’s helping us find new treatments for disease,” they write. As such, the three officials say the agency supports a new framework to regulate diagnostics that would: “focus our review resources where they would make the most difference and where the risk is highest; provide strong postmarket authorities to protect patients from harm; require transparency about test performance and limitations; complement rather than duplicate laboratory certifications; incorporate third party review and inspection; and include a pathway for earlier patient access to breakthrough technologies.” The officials say that under such a framework only about 10% of diagnostics would require premarket review. “We’d concentrate individual premarket review on tests that are novel, higher risk, marketed directly to consumers, used at home, or cross-labeled for use with a drug or other therapeutic products,” the officials write. The next tier of tests could be regulated via a pre-certification program that would take into account the test developer’s ability to design and validate a test. According to the three officials, 40-50% of clinical tests would fall into the category for pre-certification. The remaining tests would either be exempt from pre-market review or grandfathered-in as existing clinical tests. However, the officials say that FDA would need to have the authority to “take action against any problematic tests.”