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See today's BioWorld MedTech
Home » FDA divisions to develop pilot for companion diagnostic performance criteria
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FDA divisions to develop pilot for companion diagnostic performance criteria

Nov. 22, 2022
By Mark McCarty
The companion diagnostic (CDx) has been a mainstay of oncology care for several years, but Richard Pazdur, director of the U.S. FDA’s Oncology Center of Excellence (OCE), said recently in a public forum recently that the notion of a single CDx for an investigational drug has not served patients well. Pazdur said OCE and the FDA’s Center for Devices and Radiological Health are working on a pilot program that would entail the publication of performance standards for the tests used in these trials, a development that would lead to more routine development of lab-developed tests (LDTs) for these studies and thus undercut any incentive to develop a patented in vitro diagnostic for that purpose.
BioWorld MedTech Regulatory Diagnostics U.S. CDRH FDA

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