Analytics firm GlobalData has weighed in on the U.S. Food and Drug Administration (FDA)'s proposal to reclassify laboratory-developed tests (LDTs) as medical devices. FDA historically exercised enforcement discretion over LDTs, meaning that it did not actively regulate them like it does for other medical devices, so this is a significant regulatory change. Unveiled in October 2023, the proposal is designed to bolster the safety and effectiveness of these tests to safeguard patients.

However, opposition from groups like ARUP Laboratories, under the leadership of CEO Andy Theurer, highlights concerns about the potential stifling of innovation and restricted patient access to crucial tests, particularly for rare diseases. So, the FDA's proposal needs to strike a balance between safety and innovation for it to be successful, says GlobalData.

LDTs are developed, validated, and performed by a single laboratory for diagnostic or clinical purposes. These tests are often developed to meet the specific needs of a particular laboratory or patient population.

“Critics argue that the proposed regulatory framework might impede innovation in new test development,” says Selena Yu, medical analyst at GlobalData. “Navigating the complexities of LDTs in the U.S. testing market is challenging, with limited transparency on the materials used and major players.”

Yu says that while the FDA's regulation change aims to enhance market share and transparency, GlobalData's Device Approval Analyzer Database indicates a timeline of 5.9 years for test development in the United States. “Moreover, the approval process for devices may take 8 to 13 months, but the overarching concern lies in potential delays for patients accessing life-saving innovations.”

According to GlobalData, the impact of such delays became evident during the pandemic, where non-COVID-19-related in vitro diagnostic (IVD) device approvals faced setbacks due to the prioritization of Emergency Use Authorization (EUA) devices.

Justifying the hesitancy to shift focus toward approving existing LDTs is the uncertainty surrounding the duration of this process and its potential ripple effect on critical approvals.

“The ongoing debate centers on finding common ground between regulatory bodies and healthcare innovators, striking a balance that ensures patient safety without hindering the development of new and essential tests,” says Yu. The coming months may witness further discussions, potentially leading to adjustments in the proposed regulatory changes to address concerns.”

Sherrie Trigg

Editor and Director of Medical Content

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