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Health Organizations Urge Senate to Update LDT Oversight Rules

NEW YORK (GenomeWeb) – The American Cancer Society said today that its Cancer Action Network and 32 other healthcare organizations have sent a letter to congressional leaders urging them to update oversight rules for all diagnostic tests, including laboratory-developed tests.

The organizations sent the letter yesterday to US Senate Majority Leader Mitch McConnell and Minority Leader Charles Schumer, and said that they "believe strongly" that the US Food and Drug Administration should "play a critical role in a modernized framework that supports patient safety and access to valid tests."

The letter highlighted several issues related to regulating LDTs. It noted that prevailing CLIA regulations that govern laboratory practices "do not directly assess the safety and effectiveness of individual tests offered by laboratories."

Due to this gap in oversight of LDTs, "there is no systemic way to be sure of the accuracy and reliability of these tests," the groups wrote, adding that there are many cases that demonstrate challenges with this lack of oversight, including one where patients "made treatment decisions based upon invalid high-risk tests."

Two years ago, the FDA released a controversial draft guidance outlining a risk-based plan for regulating LDTs that it wanted to phase in over the course of nine years. Following the recent US elections, however, the FDA said it would hold off on finalizing those guidelines.

Instead, the agency issued a white paper earlier this month outlining a framework for LDT regulation based on more than 300 comments to a draft proposal released two years ago, a public workshop, and meetings with stakeholders.

The ACS and its healthcare collaborators — including associations, foundations, alliances, and other entities involved in research and other activities related to cancer and other medical conditions — wrote that they were ready to work with the Senate "on this important patient safety issue."