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Accelerate Diagnostics Spikes Higher On FDA News

Accelerate Diagnostics Spikes Higher On FDA News

Shares of Accelerate Diagnostics Inc (NASDAQ: AXDX), an in-vitro diagnostics company, spiked higher by more than 15 percent early Friday morning after the company provided an update relating to its Accelerate Pheno system and Accelerate PhenoTest BC kit.

Accelerate confirmed in a press release that the U.S. Food and Drug Administration granted its request to market the Accelerate Pheno system and PhenoTest BC kit for the identification and antibiotic susceptibility testing of pathogens directly from positive blood culture samples.

Typically speaking, culture-based identification and susceptibility systems require laboratory testings and can take more than 48 hours. However, Accelerate's labs can reduce the turnaround time by testing directly from a positive blood culture sample and can produce results up to 40 hours faster.

Related Link: GenMark, T2 And Accelerate Diagnostics Impress Analysts At Microbiology Forum

The company further cited data from to the Centers for Disease Control and Prevention, which stated that at least 2 million people are infected with antibiotic-resistant bacteria across the United States on a yearly basis. Moreover, antibiotic resistance contributes to the morbidity and mortality of healthcare-associated infections (HAI), which kill an estimated 75,000 people annually.

Proven Track Record

Accelerate further pointed out in its press release that a clinical study was conducted in which 39,000 tests were performed on 1,850 samples across 13 trial sites. This was a necessary pre-conduction for the FDA's approval and the results showed an overall sensitivity of 97.4 percent and specificity of 99.3 percent for identification. For susceptibility, overall essential and categorical agreement versus standard broth microdilution was 96.3 percent and 96.4 percent respectively.

Accelerate received a de novo classification, which provides a regulatory pathway toward an expedited FDA review of novel low-to-moderate risk devices for which no predicate device exists when special and general controls demonstrate reasonable assurance of safety and effectiveness.

At last check, shares of Accelerate Diagnostics were up 16.16 percent at $28.75.

Posted-In: Accelerate DiagnosticsBiotech News Health Care FDA Movers Trading Ideas General Best of Benzinga


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