TUCSON, Ariz., Sept. 18, 2019 /PRNewswire/ -- Accelerate Diagnostics, Inc. (AXDX) today announced the release of positive results from three clinical studies on the Accelerate Pheno™ system that will be presented at IDWeek™ 2019.
"We are thrilled with the results of these clinical studies, which provide further evidence of the clinical value of Pheno," commented Dr. Romney Humphries, Chief Scientific Officer of Accelerate Diagnostics. "These data, gathered across four diverse institutions and study designs, demonstrate that Pheno's rapid ID and AST results lead to significant and potentially life-saving therapy optimization for patients with blood stream infections. These results represent a meaningful increase in the body of evidence that Pheno should be standard of care."
The first of these studies is the ARLG-sponsored RAPIDS-GN clinical study conducted at Mayo Clinic and UCLA. The study successfully achieved its primary endpoint, demonstrating a statistically significant reduction in time to first antibiotic change for patients with Gram-negative blood stream infections. Specifically, the study showed a 6.3 hour decrease in time to first antibiotic adjustment and a 24.7 hour improvement in Gram-negative time to antibiotic adjustment, both of which represent statistically significant differences.
RAPIDS-GN is the first multi-center, randomized controlled trial to evaluate the impact of rapid ID and AST technology for the management of patients with blood stream infections. As expected, differences in secondary endpoints like mortality and length of stay did not achieve statistical significance. The study was not designed to include a sufficient number of patients to statistically evaluate these endpoints.
Two abstracts to be presented by the University of Iowa and University of Arkansas Medical System confirm and extend the findings of RAPIDS-GN. The University of Iowa showed antibiotic therapy was optimized within 15.3 hours for patients tested with Pheno. Among 277 interventions made based on Pheno results, 80% resulted in antibiotic change, and over one third were due to the patient not being covered for the causative organism identified. Similarly, UAMS found a 1.1 day improvement in time to optimal therapy and confirmed prior findings that demonstrated between 0.5 and 2.4 days shorter length of stay for patients with bacteremia and tested by Pheno over historical cohorts (p<0.01).
Additional data from these studies will be presented at the IDWeek™ conference in Washington, D.C. on October 3-5, 2019. The Company plans to provide further commentary at that time.
About Accelerate Diagnostics, Inc.
Accelerate Diagnostics, Inc. is an in vitro diagnostics company dedicated to providing solutions for the global challenges of antibiotic resistance and sepsis. The Accelerate Pheno™ system and Accelerate PhenoTest™ BC kit combine several technologies aimed at reducing the time clinicians must wait to determine the optimal antibiotic therapy for deadly infections. The FDA-cleared system and kit fully automate the sample preparation steps to report phenotypic antibiotic susceptibility results in approximately 7 hours, direct from positive blood cultures. Recent external studies indicate the solution offers results 1–2 days faster than existing methods, enabling clinicians to optimize antibiotic selection and dosage—specific to the individual patient's infection—days earlier.
The "ACCELERATE DIAGNOSTICS" and "ACCELERATE PHENO" and "ACCELERATE PHENOTEST" and diamond shaped logos and marks are trademarks or registered trademarks of Accelerate Diagnostics, Inc.
For more information about the company, its products and technology, or recent publications, visit axdx.com.
Certain of the statements made in this press release are forward looking, such as those, among others, about the company's projections as to when certain key business milestones may be achieved, the potential of the company's products or technology, the growth of the market, the company's estimates as to the size of its market opportunity and potential pricing, the company's competitive position and estimates of time reduction to results, and its future development plans and growth strategy. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Information about the risks and uncertainties faced by Accelerate Diagnostics is contained in the section captioned "Risk Factors" in the company's most recent Annual Report on Form 10-K, filed with the Securities and Exchange Commission. The company's forward-looking statements could be affected by general industry and market conditions. Except as required by federal securities laws, the company undertakes no obligation to update or revise these forward-looking statements to reflect new events, uncertainties, or other contingencies.
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