Retrogenix® Cell Microarray Technology Accepted into FDA’s ISTAND Pilot Program

We are excited to announce that our unrivaled Retrogenix^® Cell Microarray technology for target deconvolution and off-target safety profiling has been accepted into the FDA’s Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program. This cutting-edge in vitro platform is designed to identify on/off-target interactors for drug candidates, empowering and enabling biopharmaceutical companies to make informed decisions earlier while minimizing the reliance on large animal models.

Achieving this milestone brings the Retrogenix platform one step closer to being a fully recognized drug development tool (DDT) in the next one to two years. The technology has already played a crucial role in more than 100 investigational new drug (IND) submissions worldwide, earning strong recognition from regulators.

As part of the three-stage ISTAND Qualification Process, this acceptance offers a unique opportunity for formal FDA validation, enhancing the credibility and impact of the platform’s data. This development will give our clients even greater confidence that Retrogenix data will carry added weight during regulatory reviews, ultimately streamlining the drug approval process. This recognition from the FDA underscores the platform’s vital role in advancing drug development, benefiting clients across the pharmaceutical industry.

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WEBINAR: Maximize Safer, Targeted Biologic Development with Smarter NAMs-Based Off-Target Screening
This webinar showcases how the Retrogenix^® platform empowers smarter, earlier decisions across biologic formats. You’ll also learn how this platform, recently accepted into the FDA’s ISTAND Pilot Program, aligns with evolving regulatory support for NAMs and the shift toward reduced animal use.
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