QT replacement plan

How stem cell-based assays could help fix the problem with clinical QT testing

FDA has completed validation of a preclinical assay system that could replace clinical QT testing, a move it hopes will lower development costs and reduce false alarms of arrhythmia risk.

The question for drug developers is when the new tests will be required for all IND submissions, and how long they’ll have to be performed on top of existing QT testing.

The assay is the result of five years’ work on the Comprehensive In Vitro Proarrhythmia Assay (CiPA) initiative, which came out of a 2013 FDA-led meeting of stakeholders to discuss technologies that could eliminate the need for thorough QT (tQT) studies.

The CiPA initiative was led by FDA’s Division of Cardiovascular and Renal Products and the Health and Environmental Sciences Institute (HESI), and involved a precompetitive consortium of drug companies, CROs, academics and regulators.

“This new cellular assay is being introduced across all drug programs, across all FDA divisions, and we plan to have it replace the old QT study requirements.”

Scott Gottlieb, FDA

In remarks to the U.S. House Subcommittee on Agriculture, Rural Development on April 17, FDA Commissioner Scott Gottlieb described the new assay system as “a faster,

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