NEW YORK ─ Accelerate Diagnostics said on Tuesday that it has obtained the CE mark for a new configuration of its Accelerate PhenoTest BC kit, enabling its use in the European Union and other regions that accept the designation.
The new configuration provides antimicrobial susceptibility testing, or AST, results in approximately seven hours directly from positive blood cultures, and runs on the Accelerate Pheno system in laboratories that already have a rapid identification system.
The AST configuration provides a new option for the company's US Food and Drug Administration-cleared Accelerate PhenoTest BC kit for ID/AST testing, which also runs on the Pheno system.
"This product expansion provides fast phenotypic, [minimum inhibitory concentration]-based AST results and unique flexible workflow options to accommodate the different clinical and laboratories settings across Europe," Cherif Bousselham, Accelerate Diagnostics' senior vice president and head of sales for Europe, the Middle East, and Africa, said in a statement.
Last month, the Tucson, Arizona-based company launched the new AST configuration in the US.
Its Pheno system enables improvements in clinical outcomes including time to results, time to optimal therapy, duration of therapy, and hospital length of stay, Accelerate said, citing outcomes data from peer-reviewed publications.