Accelerate Diagnostics Receives FDA Clearance for the Accelerate Pheno™ System and Accelerate PhenoTest™ BC Kit

Accelerate Diagnostics Receives FDA Clearance

for the Accelerate Pheno System and Accelerate PhenoTest BC Kit

First fully automated solution permitted by the FDA for quantitative antibiotic susceptibility testing direct from patient samples


TUCSON, Ariz., Feb 23, 2017 (GLOBE NEWSWIRE) — Accelerate Diagnostics, Inc. (Accelerate) today announced that the U.S. Food and Drug Administration has granted the de novo request to market the Accelerate Pheno™ system and Accelerate PhenoTest™ BC kit for identification and antibiotic susceptibility testing of pathogens directly from positive blood culture samples. The blood culture kit is indicated for susceptibility testing of specific pathogenic bacteria commonly associated with bacteremia, the leading cause of sepsis.

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The Need

The Centers for Disease Control and Prevention estimate at least 2 million people each year are infected with antibiotic resistant bacteria across the U.S. In addition, antibiotic resistance contributes to the morbidity and mortality of healthcare-associated infections (HAI) that kill an estimated 75,000 people annually.1

Early diagnosis of antibiotic resistant bacteria is critical to providing patients optimal therapy. The only way to know which therapy will work is to test a range of antibiotics. Typical, conventional antibiotic susceptibility testing requires time consuming manual procedures, resulting in laboratory processing time that often exceeds 48 hours, leaving clinicians with incomplete information to provide definitive treatment during this critical time period.

The Solution

Using the Accelerate Pheno™ system and PhenoTest™ BC kit, laboratories can substantially reduce the processing time by testing directly from positive blood culture samples, which enables clinicians to provide patients optimal therapy up to 40 hours faster than conventional methods.

The BC kit is capable of simultaneous detection and identification of multiple microbial targets followed by susceptibility testing of appropriate detected bacterial organisms using morphokinetic cellular analysis (MCA) of individual microbial cells and colonies under the challenge of antibiotics. Results are intended to be interpreted in conjunction with Gram stain results.

The Accelerate PhenoTest™ BC kit includes 140 assays for both identification and susceptibility testing, of which 116 were submitted to the FDA. The kit also includes what Accelerate refers to as a “definitive” monomicrobial test indicating when a patient’s positive blood culture sample has only one targeted pathogen. In the Accelerate clinical trial the monomicrobial result had a 99.6% positive predictive value (PPV) when evaluated in combination with the Gram stain. The monomicrobial result, matched with a Gram stain, allows microbiologists to report results without additional laboratory workup. This means lab technicians can have confidence knowing they have complete results requiring no further workup when the system detects a single organism.

The Study

The Accelerate clinical study included more than 1,800 samples across 13 trial sites and exceeded the positive percent agreement (PPA) required by the FDA for identification and antimicrobial susceptibility testing. The study showed overall sensitivity of 97.5% and specificity of 99.3% for identification. For susceptibility, overall essential and categorical agreement versus the gold standard was 96.3% and 96.4% respectively2.


References:
1. Reports from the Centers for Disease Control and Prevention found cdc.gov/hai/surveillance/ and cdc.gov/drugresistance/
2. Overall results are based on FDA/CLSI 2016 breakpoints – see product labeling for additional detail

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