We’re excited to announce two important developments with the U.S. Food and Drug Administration (FDA) that represent significant momentum for SomaFocus and its potential role in human-relevant drug development.
First, the FDA has awarded Diagnostic Biochips a competitive contract over the next 2.5 years.
In collaboration with the Park Lab at Yale University, we will use SomaFocus to develop and evaluate a standardized electrophysiological approach for detecting drug-induced seizure liability in human brain organoids.
The project will investigate the ways in which depth-resolved electrophysiology can provide meaningful insight into drug-induced seizure activity, including potentially localized activity that may be difficult to detect using conventional approaches.
The FDA-supported project will generate proof-of-concept data that can help move SomaFocus toward potential FDA iSTAND qualification, a formal process through which the FDA can qualify a drug development tool for a defined regulatory use.
This project is an important step toward generating the evidence needed to evaluate our instrument's potential as a regulatory-relevant drug safety platform.
Second, the FDA has also purchased a commercial SomaFocus instrument for its research program!
The FDA’s purchase establishes the agency as a SomaFocus user, while the development contract looks toward establishing SomaFocus data as a standard for regulatory submissions by pharmaceutical and biotechnology companies.
For Diagnostic Biochips, these developments add substantial momentum to the growing adoption of SomaFocus, as we expand from neuroscience research into drug development, safety assessment, and regulatory science.
We’re proud to be working alongside researchers at the FDA and Yale on what we believe is an important opportunity for human 3D models and functional electrophysiology.