In the wake of the 2024 presidential election and the incoming U.S. Congress, Xifin’s CEO sees a window of opportunity for lawmakers to modify the Final Rule on laboratory developed tests that will be a win-win for the industry and patients.
By Lâle White
This year’s Presidential Election and Supreme Court decision to curtail the regulatory overreach of federal agencies offer policymakers the opportunity to rethink the FDA’s Final Rule on Laboratory Developed Tests, and, this time, get it right in 2025.
Diagnostics play a critical role in health care, contributing to an estimated 70% of health care decisions. Diagnostic tests now go beyond just the routine blood panel drawn at a health care provider’s office or retail pharmacy. They encompass complex genetic tests and ever-evolving diagnostics that are making advances in personalized medicine possible.
It is critical that policymakers safeguard patient access to these and other timely and innovative testing services. Millions of vulnerable patients, including more than 30 million Americans with rare diseases, depend on essential clinical testing services that only laboratory professionals can provide.
Laboratory-Developed Tests Address Unmet Needs
Laboratory developed tests (LDTs) often are created to address unmet patient needs. Trained medical professionals working in an academic setting, hospital, or small regional laboratory apply their expertise to close a gap in patient care. Their work contributes both an effective diagnostic for near-term use, as well as valuable new insights into a specific disease or condition that contributes to broader advances in care.
Beyond today’s patients and their families, policymakers in 2025 also need to recognize the role LDTs play in the development of novel therapeutics. Clinical testing services are at the cutting edge of innovation, both in what they address—rare diseases or fast-moving pathogens, for example—as well as how they tackle these challenges.
The FDA’s Rule threatens to disrupt this paradigm, with negative consequences for the entire health care system. The regulatory and cost burden imposed by the Rule disincentivizes the development of new diagnostics, sharply curtailing progress and ultimately limiting patient access to critical tests.
Laboratory Developed Tests’ Fate—a Waiting Game?
While we wait for the courts to apply post-Chevron guidance to decide the fate of FDA’s Rule, Congress has the opportunity to settle the issue definitively. They can address the concerns of hospitals, academic medical centers, independent laboratories, clinicians, and patients by putting forth a legislative solution that ensures the accuracy of laboratory developed tests that come to market, while preserving access for patients and fostering much-needed innovation in health care. Indeed, members of the House Energy and Commerce Committee have echoed some of these same concerns when they examined the serious economic and public health implications of applying medical device regulation to LDTs.
Moving forward, Congress can rely on the guardrails set forth in the Clinical Laboratory Improvement Amendments (CLIA), which is administered by the Centers for Medicare & Medicaid Services and the CDC in addition to the FDA. This more inclusive and holistic approach better takes into account the unique attributes and contributions of laboratory diagnostics.
Now is the time for Congress to act. Several Members of Congress have previously indicated their support for the VALID Act (Verifying Accurate Leading-Edge IVCT Development). With uncertainty hanging over implementation of FDA’s Rule, Congress can put in place a path that helps patients, while also providing support for future innovation.
About the Author: Lâle White, executive chairman and CEO of XiFin, is a veteran of the medical financial management and regulatory compliance field, with more than 35 years of experience.