PyroDex Contributes to Landmark NIST Study on Sterility Testing

At PyroDex Testing, we are proud to announce our participation in the NIST Interlaboratory Study Number 2, a groundbreaking research initiative that took place from February 12 - March 4, 2025. This study, led by the U.S. National Institute of Standards and Technology (NIST), was designed to evaluate the Monocyte Activation Test (MAT) as a sterility testing tool—marking the first large-scale comparative study of MAT in this field.

The results are in, and they provide strong evidence supporting the MAT as a powerful alternative to conventional sterility tests. This is a major milestone in ensuring the safety of cell and gene therapy products, as traditional sterility tests often fall short in detecting pyrogens that can trigger harmful immune responses in patients.

By contributing to this study, PyroDex has played a key role in shaping the future of sterility testing—one that is more accurate, ethical, and aligned with modern biopharmaceutical innovations.

We believe this research will help drive industry-wide adoption of MAT, improving the safety and reliability of advanced therapies. Stay connected with us as we continue pushing the boundaries of non-animal safety testing in the biopharmaceutical industry.

If you’d like to discuss how our MAT-based sterility testing can support your product development, feel free to reach out!