Leading healthcare companies and organizations representing patients, providers, laboratories, and diagnostic manufacturers have called upon House and Senate leaders to advance legislation that would reform and modernize the processes for bringing innovative diagnostics and clinical laboratory tests to market.

In a letter to the chairmen and ranking members of the Senate Committee on Health, Education, Labor, and Pensions (HELP) and House Energy and Commerce Committee, more than 80 organizations urged Congress to prioritize meaningful diagnostic oversight reform in 2018, including regulation of both laboratory-developed tests (LDTs) and in vitro diagnostics (IVDs).

Scott Gottlieb, MD, FDA.

Scott Gottlieb, MD, FDA.

The call for action represents the first time that manufacturers, providers, labs, and patient groups have come together to make a collective push for reform in the regulation of clinical diagnostics, and comes on the heels of recent public comments by FDA Commissioner Scott Gottlieb, MD, suggesting that comprehensive legislative action on clinical laboratory diagnostics would be timely and appropriate.

“We all share the goal of accelerating development of and access to new, groundbreaking medical advances that have the potential to greatly improve patient health and well-being,” says Julie Khani, president of the American Clinical Laboratory Association. “To deliver on that promise without disrupting patient access, we urge Congress to prioritize diagnostic reform this year and help ensure a sustainable path for future diagnostic innovation.”

Prioritizing diagnostic reforms this year would build on the efforts of both congressional committees, as well as on the work of Reps. Larry Bucshon (R–IN) and Diana DeGette (D–CO), who early last year released a discussion draft of legislation entitled the Diagnostic Accuracy and Innovation Act. The discussion draft contemplates a host of policies that are important for stakeholders to consider for a modernized diagnostic framework.

According to the signatory organizations, conflicting regulatory requirements and oversight authorities between FDA and the Centers for Medicare and Medicaid Services have significantly slowed progress in bringing groundbreaking diagnostic tests to market. Stakeholders have consistently called on Congress to reform the regulatory responsibilities of the two primary agencies, and to develop a modernized framework for diagnostic oversight.

“For patients and their families, a diagnostic test is often the first step toward a treatment plan that can attack cancer at its core, and accurate and reliable diagnostics are necessary to make the best decisions,” says Christopher Hansen, president of the American Cancer Society Cancer Action Network. “Diagnostic reform is not only essential for care delivery today, but it will serve as the backbone for ensuring that patients continue to benefit from ever more personalized therapies going forward.”

Van Meter

Susan Van Meter, AdvaMedDx.

“Innovative medical diagnostics tests and technologies are the foundation for evidence-based medicine, allowing for early intervention that improves patients’ health outcomes, often lowering costs for the broader health system,” says Susan Van Meter, executive director of industry association AdvaMedDx. “A modernized and predictable, risk-based, diagnostics regulatory framework would speed the pace and reach of cutting-edge diagnostics, allowing patients to benefit more broadly and rapidly from breakthrough diagnostic technologies. Now is the time for Congress to advance needed diagnostic reforms.”

“A more streamlined and modernized regulatory approach to diagnostics and clinical lab tests will open the door to a new era of medicine and cancer care,” says Jeff Allen, president and CEO of Friends of Cancer Research. “We applaud congressional leaders who have already made progress in advancing common-sense policy changes, and look forward to working with policymakers in both parties to make diagnostic reform a reality.”

To view the full letter, click here.