The landscape of laboratory-developed tests (LDTs) is facing a significant regulatory shift as the US Food and Drug Administration (FDA) proposes to regulate them as medical devices. The new proposed rule published in October 2023 states the FDA’s intention to regulate LDTs, including those that are manufactured by a laboratory, as in vitro diagnostics (IVDs). The agency’s goal is to ensure the safety and effectiveness of these tests to prevent potential harm to patients from false results or claims. Those against this potential ruling must submit their comments by 4 December 2023. Groups such as ARUP Laboratories have spoken against this rule, urging the FDA to reconsider, citing concerns about the potential impact on innovation and patient access to essential tests.
Groups against the FDA’s proposed regulatory framework claim that it is overly burdensome and may stifle innovation in new test development. ARUP Laboratories, led by CEO Andy Theurer, emphasises the importance of a regulatory environment that fosters innovation while ensuring patient safety. The company argues that an excessively strict regulatory framework would not only impede innovation but also limit patient access to safe and essential tests, particularly for those with rare diseases.
The world of LDTs is a black box in the US testing market: it is challenging to map out what materials are used in the LDTs and thus who the major players are in this market. While this FDA regulation change might help with regards to market share and test development transparency, according to GlobalData’s Device Approval Analyzer, it takes an average of 5.9 years to develop a test in the US. Additionally, the same database shows that it may take eight to 13 months to approve a device.
Every moment spent navigating the approval process for medical devices translates to a potential delay in patients accessing life-saving innovations. The impact of such delays was starkly evident during the pandemic, where non-Covid-19-related IVD device approvals experienced substantial setbacks, overshadowed by the prioritization of Emergency Use Authorization (EUA) devices. The hesitation to shift focus towards approving existing LDTs is justified, given the uncertainty surrounding the duration of this process and the potential ripple effect on critical approvals.
As the debate unfolds, the challenge lies in finding common ground between regulatory bodies and healthcare innovators. Striking a balance that ensures patient safety without stifling the development of new and essential tests is crucial. The coming months will likely see further discussions, possibly leading to adjustments in the proposed regulatory changes to accommodate the concerns raised by ARUP Laboratories and others in the industry.