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FDA Clears Accelerate Dx's Bloodstream Infection Test

NEW YORK (360Dx) – The US Food and Drug Administration has cleared Accelerate Diagnostics' test kit and instrument platform for identifying organisms that cause bloodstream infections, the company said late Thursday.

The kit also provides information about antibiotic sensitivity, and with the clearance Accelerate can market the test and platform in the US.

The PhenoTest BC Kit runs on Accelerate's Pheno System and can identify bacteria or yeast from a positive blood culture in about 1.5 hours, compared to the 24 to 48 hours it takes with traditional identification and antibiotic susceptibility tests, the FDA said.

Also, for some organisms, the test — in about 6.5 hours after the organisms are detected from blood cultures — provides crucial information to guide treatment recommendations, the FDA said. It added that the test can identify 14 different bacterial species and two yeast species that cause bloodstream infections and provides antibiotic sensitivity information on 18 selected antibiotics for a subset of identified organisms as appropriate.

Accelerate said that the blood culture kit is indicated for susceptibility testing of specific pathogenic bacteria associated with bacteremia, the leading cause of sepsis. Citing statistics from the US Centers for Disease Control and Prevention, the company said that at least 2 million people in the US are infected each year with antibiotic-resistant bacteria. Antibiotic resistance also is a major contributor to healthcare-associated infections that kill 75,000 peopole annually.

The PhenoTest BC Kit is a multiplexed in vitro diagnostic test that uses nucleic acid fluorescence in situ hybridization identification and quantitative antimicrobial susceptility testing technology. It can detect and identify multiple microbial targets and then perform susceptibility testing of detected bacterial organisms based on morphokinetic cellular analysis of individual microbial cells and colonies "under the challenge of antibiotics," Accelerate said. 

The PhenoTest BC Kit measures the similarity of an infection-causing organism's genetic material to DNA known to be unique to specific bacteria or yeast, the FDA said. Upon being identified, the organism is mixed with antibiotics and the bacteria's growth is measured by time-lapse images. If the organism does not grow when the antibiotic is present, then the antibiotic may be appropriate for treatment.

The FDA cleared the kit and the Pheno System under its de novo premarket review pathway. It reviewed a clinical study of 39,000 tests conducted on 1,850 positive blood cultures. Accelerate said that the study demonstrated overall sensitivity of 97.4 percent and specificity of 99.3 percent for identification. For susceptibility, the overall essential and categorical agreement, when compared to standard broth microdiultion, was 96.3 percent and 96.4 percent, Accelerate said. 

The kit includes 140 assays for identification and susceptibility testing, of which 116 were submitted to the FDA. It also includes a "definitive" monomicrobial test that indicates when a patient's positive blood culture sample has only one targeted pathogen. 

"We are excited to offer microbiologists and treating physicians earlier intelligence about the infection they fight on a daily basis," Accelerate President and CEO Lawrence Mehren said in a statement. "Bringing this solution to market has been a culmination of years of effort." 

"By identifying organisms and knowing earlier which antibiotics the organism is likely to respond to, healthcare professionals can treat patients with bloodstream infection more appropriately," said Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA's Center for Devices and Radiological Health, in a statement.

In early morning trading on the Nasdaq on Friday, Accelerate's shares were up 15 percent at $28.52.