Predict cardiotoxicity, QRS risk and proarrhythmic risk using human relevant models for CiPA screening to generate data aligned with FDA guidance and next-generation regulatory expectations.
A CiPA Member
Clyde is an official core member of the Comprehensive In Vitro Proarrhythmia Assay CiPA consortium, being instrumental in validating the next-generation cardiac safety assays using the CellOPTIQ® platform for CiPA screening in collaboration with the FDA and global industry partners.
Clyde is the only Voltage Sensitive Dye CRO recoginized by the FDA to provide CiPA data for your IND submission.
Clyde’s CiPA Assay
Our CiPA screening assay uses voltage-sensitive dyes in spontaneously beating human iPSC-derived cardiomyocytes to measure compound effects on cardiac electrophysiology.
Representative CiPA data: Predicting Pro-arrythmic Risk
Clyde’s CiPA assay has demonstrated strong predictive performance for human QT prolongation and proarrhythmic risk during FDA validation studies (CiPA 28 study). Compared to traditional platforms such as MEA, the assay has delivered improved prediction of pro-arrhythmic risk with reduced false positives and false negatives.
High Predictive Power for human cardiac risk
95% Positive Predictive power
The assay demonstrated 95% positive predictive power in CiPA validation studies in NCARDIA Cor 4U cell line, correctly identifying 17 out of 18 high- and medium-risk compounds. Strong correlation with clinical QTc data supports the translational relevance of the platform. The plot shows this data vs the human QTc data with +/- 10x concentration (dotted lines).
Start your CiPA Cardiac Safety Study
Speak with our scientists to design a CiPA-aligned cardiac safety strategy tailored to your compound and development stage. Alternatively email us at info@clydebio.com