The Utah University-based ARUP Laboratories is calling on the US Food and Drug Administration (FDA) to reverse its decision to regulate Laboratory-Developed Tests (LDTs) as medical devices.
Previously, the FDA introduced a proposed rule change that would see LDTs regulated as medical devices, proposing to alter regulations to make explicit that In Vitro Diagnostic Products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act. Specifically, when the manufacturer of the IVD is a laboratory.
Utah’s ARUP Labratories is calling the move “overly burdensome” citing negative impacts on patient care and what the company says are flawed estimates from the FDA of the number of LDTs ordered and their performance.
ARUP Labratories CEO Andy Theurer said: “We agree that poor-quality tests should not be on the market or used in patient care, but an overly burdensome regulatory framework will stifle innovation and limit access to testing that addresses unmet clinical needs. Ultimately, it will hurt the very patients the FDA is trying to protect.”
The laboratory firm is citing research conducted by itself and the Spencer Fox Eccles School of Medicine at the University of Utah, published in the American Journal of Clinical Pathology, that argues that 93.9% of tests ordered in 2021 were tests that were cleared, approved, and authorized by the FDA.
The study, titled ‘Laboratory-Developed Tests Account for a Small Minority of Tests Ordered in an Academic Hospital System,’ examined 3,016,928 tests throughout 2021 and found that some of the most commonly ordered LDTs were used for mass spectrometry assays and tests used in the care of immunocompromised patients.
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The FDA has said that it is intent on further regulating LDTs in a bid to update the Medical Device Amendments of 1976 ruling, arguing that LDTs have become much more complex and varied and conducted on larger scales as well as frequently used in healthcare decisions.
In a statement published by the FDA following the announcement, the US regulator said the proposed rule is aimed at helping to ensure the safety and effectiveness of these tests to better ensure patient safety.
In an open statement published by ARUP Laboratories, the company argues that this change will have the opposite effect by eliminating access to safe and essential tests, especially for patients with rare diseases, by way of significantly increasing the amount of regulatory bureaucratic work expected from the industry and the regulator.
ARUP Labratories statement reads: “The FDA simply does not have the staff to support a hundred or thousand-fold increase in regulatory submissions, nor is it likely that such professional expertise could be reasonably hired.
“It is therefore reasonable to conclude that the proposed rule, contrary to the assertions of the FDA, would directly lead to a reduction of existing and future safe and essential testing.”