Adial Pharmaceuticals (ADIL) announced the successful completion of the analytical validation of a cheek swab collection method for testing patients for both clinical trial usage as well as future commercial application. This major step marks a key milestone in advancing AD04 toward Food & Drug Administration, FDA, registration. The objective of the partnership was to develop an analytically validated gene test in a CLIA-certified laboratory that would identify the important SNPs of the serotonergic system used for identifying patients for the upcoming Phase 3 program for AD04. This would serve as the starting point for development of a commercial companion diagnostic test for which a cheek swab specimen can be easily collected in a physician’s office or at home.
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