The CIPA assay
helps physicians and health care professionals keep their clinical records current. It includes data from a single cardiac cycle, three peripheral blood monies, five blood components, and an electrocardiogram
. This makes it easier for them to follow patients’ progress and see where they’re at in the treatment process. CIPA assays also help physicians improve drug labelling. Here are some reasons why this assay is so useful.
Identify proarrhythmic potential of new drugs
The Comprehensive in vitro Proarrhythmia Assay (CiPA) is a drug development tool that uses a combination of mechanistic studies to determine the proarrhythmic risk of TdP-containing drugs. This assay is a promising new approach that can help improve drug development by providing early-stage drug screening results. With the new technology, it will be possible to identify QTc-prolonging drugs without the need for extensive ECG monitoring during clinical phase III trials. This new technology will also enable pharmacological companies to update the labels of new drugs to reflect the potential proarrhythmic risk.
The CiPA assay was designed to be a fit-for-purpose paradigm, which uses a mechanistic in vitro cardiac model as the primary predictor of proarrhythmic risk of new drugs. It will also use a ventricular myocyte model developed from human iPSC-derived cardiomyocytes
and phase I clinical ECG data to assess drug effects on repolarization.
While QT prolongation tests are an excellent surrogate for proarrhythmic risk, they are labour-intensive and lack sensitivity. Several drugs have been classified by an expert panel as proarrhythmic risk. Ranolazine and amiodarone are two examples. Nevertheless, these drugs have very low proarrhythmic risks. For these reasons, identifying proarrhythmic potential of new drugs is essential.
Maintain an ongoing clinical trial record
Using a CIPA assay is a convenient way to keep an ongoing clinical trial record. Using this technology, physicians and other health care professionals can track the progress of patients throughout the duration of the clinical trial. These reports include data from one cardiac cycle, three peripheral blood monies, five blood components, and electrocardiogram. As with any medical device, this technology has many benefits.