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Nanosphere Expects New Study to Augment Clinical Use of Gram-Positive Blood Culture Test

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Molecular diagnostics firm Nanosphere believes the results of a new multicenter study that assessed the performance of its Verigene Gram-Positive Blood Culture Test could lead to broader clinical adoption, according to a company spokesperson.

Lindsay Saxon told BioArray News this week that the results of the study, published recently in the journal PloS Medicine, are "significant" as they "further validate the compelling value" of the test.

While the US Food and Drug Administration cleared the GP-BC test for clinical use last year, company executives acknowledged in the firm's first quarter earnings call that it has taken "longer than initially anticipated" for first adopters to validate and implement the test (BAN 5/13/2013). To accelerate adoption of the array-based test, the company has invested in commercialization efforts, including providing new clients with access to reference data. The new study could potentially aid them in winning over new customers, who have traditionally relied on culture.

As detailed in the new paper, a team led by researchers at the Medical College of Wisconsin evaluated Nanosphere's GP-BC Test to detect Staphylococcus aureus and 11 other gram-positive bacterial gene targets known to cause bloodstream infections, as well as three genetic resistance determinants, directly from positive blood culture media.

A retrospective analysis of turn-around time found that the Verigene BC-GP Test identified methicillin-resistant Staphylococcus aureus and vancomycin-resistant Enterococcus species an average of 42 hours faster than reference methods.

Corresponding author Nathan Ledeboer, an associate professor of pathology at MCW, said in a statement that the researchers found the GP-BC test to be capable of detecting the "leading causes of gram-positive bacterial bloodstream infections" directly from positive blood cultures, and said the test has the "potential to markedly reduce turn-around time for reporting."

Saxon said that the publication "helps elevate understanding of the important role molecular diagnostics play in the … detection of bacteria known to cause bloodstream infections," and that the Northbrook, Ill.-based company anticipates that there will be additional studies published over the coming months that "demonstrate the clinical and economic benefits" of the GP-BC test.

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