A CiPA Member
Clyde is an official core member of the CiPA consortium, being instrumental in validating the CiPA assay with the FDA using the CellOPTIQ® platform.
Clyde is the only Voltage Sensitive Dye CRO recoginised by the FDA to provide CiPA data for your IND submission.
Clyde’s CiPA Assay
Cylde’s CiPA assay uses voltage sensitive dyes to measure compound affects on voltage using spontaneously beating hiPSC cardiomyocytes. Effects on tRise, APD 10-90, triangulation, cycle length and diastolic interval are measured producing a proarrhythmic risk score (high, medium, low).
Typical CiPA data – Dofetilide
During the validation of Clydes CiPA assay with the FDA (CiPA 28 study), the assay has been shown to highly predictive of human QT and proarrhythmic risk. Clydes’ CiPA assay has also been shown to be supperior over the MEA platform, especially its ability to predict proarrhythmic risk, but also producing an extremely low false positive and negative occurrence.
Clyde’s CellOPTIQ CiPA assay is highly predictive of human QT
The assay showed 95% positive predictive power as part of the CiPA study. The above graph shows the Clyde’s dataset using the CIPA protocol to measure optical action potentials in NCARDIA Cor4U cell line. 17 out of 18 high and medium risk compounds were correctly identified. The plot shows this data vs the human QTc data with +/- 10x concentration (dotted lines).
Start a study with CLYDE
To enquire about how Clyde could help with your project complete the enquiry form below and we’ll be get back to you as soon as we can. Alternatively email us at info@clydebio.com