Adial Pharma Completes Analytical Validation Of Cheek Swab Collection Method For Testing Patients For Both Clinical Trial Usage As Well As Future Commercial Application

Author: Benzinga Newsdesk | October 09, 2025 08:40am

Adial Pharmaceuticals, Inc. (NASDAQ:ADIL) ("Adial" or the "Company"), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, today 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 (single nucleotide polymorphisms) 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.   

Key Highlights from the Collaboration with Genomind:

• Through the collaboration with Genomind, Adial can now test SNPs in the HTR3A, HTR3B, and SLC6A4 gene.
   
• Additionally, Adial can test long and short forms of the SLC6A4 promoter.
   
• Genomind validated the assay for accuracy, reproducibility, and robustness utilizing commercially sourced human samples.
   
• Genomind's validation process included a multitude of parameters such as inter- and intra-assay precision, diverse sample origins and ethnic backgrounds, operators, instruments, and assay reagent lots.
   
• The assay developed by Adial with the expertise of Genomind demonstrated 100% concordance across all SNP testing.

Posted In: ADIL