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Specific Diagnostics Gets CE-IVD Mark for Rapid AST System

NEW YORK – Mountain View, California-based diagnostics developer Specific Diagnostics announced Thursday it has obtained CE-IVD registration for its rapid antimicrobial susceptibility testing system.

The system, called Reveal, uses volatile organic compound-based metabolomic signature technology to obtain antibiotic susceptibility information directly from positive blood cultures in less than five hours. It will initially be launched at six evaluation sites in France. 

"Reveal will provide hospital microbiology laboratories a much needed option for rapidly obtaining a susceptibility profile," said Specific's CEO Paul Rhodes in a statement. "The system's affordable cost, ease of use and high throughput is compatible with the requirements of hardpressed microbiology laboratories." 

The firm also announced completion of a successful ISO-13485 quality system audit. 

Mountain View, California-based Specific intends to offer Reveal for evaluation and clinical use in France and the United Kingdom during Q4 2020 and Q1 2021, with availability in additional markets thereafter.