With this announcement, the company initiated the clinical trial process for the system to be approved by the Food and Drug Administration (FDA). The system is designed to serve as a platform capable of providing both ID and AST services to allow laboratory results to come in quicker than current testing methods from patient samples.
"We are encouraged by the results of the pilot study," Lawrence Mehren, president and CEO of Accelerate Diagnostics, said. "While small, the pilot, combined with the extensive external preclinical work we have done, provides additional confidence in our investigational system, our first investigational test kit and our trial intended to support FDA clearance."
A company representative stated that the system is believed to be able to produce results within hours of receiving a sample rather than several days. This study incorporated 10 sites and analyzed 272 samples. Sensitivity and specificity for identification activity was reported at 96.6 and 99.4 percent, respectively. In AST activity, the essential and categorical agreement was at 94.3 percent and 91.3 percent, respectively.
According to the company website, "Accelerate Diagnostics, Inc., is an in vitro diagnostics company dedicated to providing solutions to the global challenge of drug-resistant organisms and hospital-acquired infections."