The CiPA (Comprehensive in Vitro Proarrhythmig Assay) Initiative


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Key Facts

Myocyte Pilot Study

Literature

CiPA: Novel Cardiac Safety Initiative

Led by HESI, FDA, and the Safety Pharmacology Society

Traditional cardiac safety testing relies on hERG and QT assessments, which alone are insufficient to predict arrhythmia risk. The Comprehensive In Vitro Proarrhythmia Assay (CiPA) initiative advances ICH S7B guidelines by integrating multi-ion channel analysis, in silico modeling, human iPSC-derived cardiomyocytes, and clinical electrophysiology.

Agilent Support for CiPA

Agilent’s xCELLigence RTCA CardioECR system was selected as a core technology for CiPA Phase I and II validation studies (36 compounds total). These studies demonstrated robust sensitivity, specificity, and reproducibility of hiPSC-cardiomyocyte assays for detecting proarrhythmic risk.

Easy, Flexible Workflow

No cell labeling required. Simply seed cells, monitor function in real time, and evaluate drug efficacy, mechanism, and cardiotoxicity - streamlining cardiac safety testing with human-relevant biology.

CiPA Myocyte Pilot Study

Published CiPA Myocyte Pilot Study results confirm hiPSC-derived cardiomyocytes as a predictive, scalable platform for cardiac safety assessment. Using CardioECR, Agilent validated concentration-dependent electrophysiological effects and arrhythmia-related events consistent with known ion-channel mechanisms.

xCELLigence RTCA CardioECR Publications (CiPA Phase I Studies)

  1. Multi-parametric assessment of cardiomyocyte excitation-contraction coupling using impedance and field potential recording: A tool for cardiac safety assessment.
    Zhang X, Guo L, Zeng H, White SL, Furniss M, Balasubramanian B, Lis E, Lagrutta A, Sannajust F, Zhao LL, Xi B, Wang X, Davis M, Abassi YA. J Pharmacol Toxicol Methods. 2016 Sep-Oct;81:201-16.
  2. Cross-Site Reliability of Human Induced Pluripotent stem cell-derived Cardiomyocyte Based Safety Assays Using Microelectrode Arrays: Results from a Blinded CiPA Pilot Study.
    Millard D, Dang Q, Shi H, Zhang X, Strock C, Kraushaar U, Zeng H, Levesque P, Lu HR, Guillon JM, Wu JC, Li Y, Luerman G, Anson B, Guo L, Clements M, Abassi YA, Ross J, Pierson J, Gintant G. Toxicol Sci. 2018 Aug 1;164(2):550-562.

xCELLigence RTCA CardioECR Publications (CiPA Phase II Studies)

  1. International Multisite Study of Human-Induced Pluripotent Stem Cell Derived Cardiomyocytes for Drug Proarrhythmic Potential Assessment.
    Blinova K, Dang Q, Millard D, Smith G, Pierson J, Guo L, Brock M, Lu HR, Kraushaar U, Zeng H, Shi H, Zhang X, Sawada K, Osada T, Kanda Y, Sekino Y, Pang L, Feaster TK, Kettenhofen R, Stockbridge N, Strauss DG, Gintant G. Cell Rep. 2018 Sep 25;24(13):3582-3592

For Research Use Only. Not for use in diagnostic procedures.