What's Happening?
Axion BioSystems announced that its Human iPSC-Cardiomyocyte MEA Assay has been accepted into the FDA's ISTAND Program. This marks the first stem cell-derived cardiac safety assay to be included in the program, which aims to advance innovative methodologies for drug development. The assay uses human-induced pluripotent stem cell-derived cardiomyocytes to assess cardiac electrophysiology, providing insights into clinical cardiovascular repolarization risks. The acceptance into ISTAND reflects the FDA's interest in non-animal testing strategies that enhance early cardiac risk assessment.
Why It's Important?
The inclusion of Axion's assay in the ISTAND Program represents a significant step forward in cardiac safety testing, potentially leading to broader regulatory
acceptance of stem cell-derived data. This advancement could improve the early detection of cardiac risks in drug development, reducing late-stage failures and enhancing patient safety. The move aligns with a growing trend towards human-relevant testing methods, which could transform regulatory practices and drug development processes.
What's Next?
Axion BioSystems will collaborate with the FDA to develop a Qualification Plan for the assay, defining its context of use and validation strategy. Successful qualification could lead to wider adoption of the assay in regulatory settings, influencing future drug development programs. The company will continue to engage in initiatives that promote the use of human-relevant cardiac safety assessments, potentially setting new standards in the industry.
