The CiPA technology service for cardiac safety at NUOXINTE Biotech can help new drug development companies predict and evaluate the likelihood of drug-induced cardiac arrhythmias, enabling them to make effective decisions. One of the main reasons for the discontinuation or withdrawal of new drugs from the market is the adverse reactions caused by drug-induced arrhythmias (apical torsion ventricular tachycardia, TdP). At present, hERG assay, as the main means of evaluating drug induced arrhythmic toxicity, has many issues with its sensitivity and specificity. Therefore, institutions such as the US FDA, CSRC, HESI, and SPS have proposed new recommendations for preclinical drug cardiac safety assessment - the Comprehensive In Vitro Arrhythmia Risk Assessment (CiPA). CiPA was included in the new guideline ICH E14/S7B by ICH in February 2022 and will be implemented in China in July 2023. As a member of HESI, the company participated in the revision of the new guidelines and developed iPS derived cardiomyocytes (iPSC CM) - Cardiosight®, which is crucial for CiPA detection， Created a new cardiac safety testing method and obtained international ISO17025 certification. Nuoxinte Biotechnology utilizes its self-developed Cardiosight® The product provides CiPA technology services for cardiac safety, with significant advantages in trial design and cost, and can provide the most accurate results according to the latest standards. For more detailed information, please contact us.

hERG assay is a fundamental experimental method for evaluating the toxicity of arrhythmia in cardiac safety pharmacology. The hERG channel is an essential ion channel (K+) in cardiac electrical activity. The blockade of hERG channel by drugs can cause QT interval prolongation as an indicator for detecting the possibility of arrhythmia. However, simply detecting the impact on hERG channels can result in incorrect results such as false positives or false negatives, leading to the erroneous exclusion of drugs with potential good efficacy or the incorrect introduction of drugs with cardiac toxicity into the market. The new strategy CiPA utilizes iPSC CM modeling to more accurately assess the risk of arrhythmia by detecting a wider range of cardiac ion channels (Na2+, Ca2+, K+) compared to hERG assay. In addition, CiPA can also be used for high-throughput drug screening in vitro.

NUOXINTE utilizes the company's self-developed iPSC CM Cardiosight® Provide CiPA technical services and verify their excellence through various methods. The CiPA project lists 28 representative drugs related to cardiac safety pharmacological trials, divided into three categories from low to high-risk groups. We are already in Cardiosight® 28 drugs were tested and analyzed using an electrode array (MEA), and the results showed consistency with the drug risk group classification, proving Cardiosight® Accuracy of drug response.

NUOXINTE CiPA technology service confirms the possibility of arrhythmia by measuring the electrical signals of actual beating of myocardial cells. Compared with hERG assay, it has higher accuracy and detection speed. Our MEA testing method has obtained international ISO17025 certification and has been granted multiple patents.

NUOXINTE has a CiPA professional technical team to assist clients in designing the required experiments and recommend suitable testing platforms based on the experimental objectives. The company currently has platform equipment including Agilent's CardioECR myocardial cell function analyzer, Axion's microelectrode array (MEA), Nanion's FLEXcyte 96 myocardial cell contractility measurement instrument, and CardioExcyte 96 myocardial cell analyzer. MEA can measure the electrical signals of myocardial cells, while FLEXcyte 96 can measure the contractile force of myocardial cells. CardioExcyte 96 and CardioECR can simultaneously measure the electrical signals and contractility of myocardial cells. For more information, please contact our professional technical team.

NUOXINTE CiPA technology services provide a variety of analytical indicators, including Field Potential Duration (FPD; Field Potential Duration); Beat rate; Spike amplitude (height of active potential amplitude); Beating irregularity (continuity of field potential); Conductivity (direction and conductivity of electrical signal transmission). These indicators will be converted into change rates (percentage%), analyzed for the possibility of TdP arrhythmia, and a report will be provided to customers. The results report of CiPA technical services includes the concentration of the commissioned drug, experimental design, equipment information, and result analysis. The report also includes raw data, which can be submitted as materials required for the drug to enter clinical practice.

The CiPA technical service takes approximately one month from testing to submitting the final report. If the customer requires, experimental result data can be provided within 2 weeks in advance. NUOXINTE suggests that drugs should be dissolved in solvents as much as possible and provided in liquid form. Please contact us for detailed service procedures.