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Drug-Induced Long QT
Improve the Cardiac Safety Data in Your Clinical Trials with Genetic Testing
Drug-induced QT prolongation is a leading cause of delays in drug development and drug withdrawals from the market. Over the past few years, several drugs have been removed or restricted from the market as a result of adverse effects related to cardiac safety. As a result, regulatory agencies and the FDA require more rigorous cardiac safety testing in drug development programs.
The Advantages of Implementing Genetic Testing for Drug-Induced QT Prolongation in Clinical Trials
- More completely assess safety of anti-arrhythmic drugs
- Improve safety for anti-arrhythmic drugs
- FDA / ICH suggests consideration of genotyping when patients experience marked QT prolongation or TdP
- Quickly and accurately characterize outliers in TQT studies
- In Phases II-III, use outlier analysis to screen out individuals with mutations
- Facilitate drug portfolio management
- Earlier Risk Assessment
- Direct later development
"Many forms of Long QT Syndrome are now known to be linked to mutations in genes encoding cardiac ion channel proteins. . . Genotyping patients who experience marked prolongation of the QT/QTc or TdP while on drug therapy should be considered."
- FDA E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential
for Non-Antiarrhythmic Drugs
Cogenics’ Genetic Test for Drug-Induced QT Prolongation offers complete sequencing, variant reporting and interpretation for the coding-relevant regions of five genes known to be important to both familial and Drug-Induced Long QT: KCNQ1, KCNH2, KCNE1, KCNE2, and SCN5A.
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