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BD Gets FDA Clearance for Combo Hospital-Acquired Infections Test

NEW YORK (GenomeWeb News) - The US Food and Drug Administration has cleared a Becton Dickinson DNA-based blood test for two common and dangerous hospital-acquired infections, the company’s BD Diagnostics segment said today.
 
The FDA has granted 510(k) clearance to BD Diagnostics’ GeneOhm StaphSR assay, which identifies Staphylococcus aureus and methicillin-resistant Staphylococcus aureus from patients with positive blood cultures in around two hours, the company said. The test will enable physicians to make earlier diagnoses of these infections, which the firm believes will significantly reduce healthcare costs.
 
BD noted that it recently submitted an application with the FDA to add nasal swab and wound claims to the GeneOhm StaphSR assay. The firm also said it has filed with the FDA for clearance of gene-based tests for two other organisms that cause hospital-acquired-infections: vancomycin-resistant Enterococci and a toxin gene associated with Clostridium difficile.
 
Becton Dickinson bought San Diego-based molecular diagnostics company GeneOhm in early 2006 for $230 million and an extra $25 million in incentives. The acquisition provided the firm with the initial Staphylococcus aureus assay and a pipeline of molecular tests for hospital-acquired infections.
 
In separate news related to BD, the firm’s stock was upgraded today to “overweight” from “neutral” by JPMorgan analyst Michael Weinstein. He also raised his fiscal 2008 profit estimate for the firm to $4.36 per share from $4.32.
 
 

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