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Nanosphere, Inc. (Nasdaq:NSPH), a company enhancing medicine through targeted molecular diagnostics, offers the Verigene® Gram-Negative Blood Culture Test (BC-GN), approved by the FDA in June 2014 as the first and only FDA-cleared test that rapidly identifies the five carbapenem resistance genes most commonly associated with carbapenem-resistant Enterobacteriaceae (CRE).
Three recent outbreaks of CRE, also known as “superbugs,” are shining light on the dangers associated with multi-drug-resistant infections.
Across three U.S. medical centers, the outbreaks led to two deaths and affected nearly 300 patients overall. While considered rare in the U.S., the U.S. Centers for Disease Control and Prevention (CDC) notes that 48 states have had confirmed cases of CRE infections.
“The recent outbreaks of CRE at multiple institutions in the U.S. illustrate the unfortunate spread and associated need for rapid and accurate diagnostics,” said Michael McGarrity, Nanosphere’s Chief Executive Officer. “Supported by the recent call to action by the CDC to advance antibiotic stewardship and use of diagnostic tests, Nanosphere stands uniquely positioned to address this critical healthcare challenge.”
The Verigene Gram-Negative Blood Culture Test (BC-GN) detects CRE days faster than current testing methods, which Nanosphere believes may enable clinicians to optimize treatment of patients.
The Verigene System uses Nanosphere’s core proprietary gold nanoparticle chemistry to offer highly sensitive, highly specific molecular diagnostic results through low-cost multiplexing. The Verigene System rapidly and accurately detects infectious pathogens and drug resistance markers by targeting conserved genetic regions of a bacterium or virus. Currently, the multiplexed Verigene assays target infections of the bloodstream, respiratory tract and gastrointestinal tract. The information gathered from Verigene test results enables clinicians to make informed patient treatment decisions more quickly, which may result in improved patient outcomes, reduced costs, optimized antibiotic therapy, and reduced spread of antibiotic resistance.
CRE are a group of multi-drug-resistant bacteria sometimes referred to as “superbugs.” They are especially difficult to treat because they have become resistant to a category of antibiotics that includes penicillin, amoxicillin and several other commonly used drugs. According to the CDC, mortality rates associated with CRE infections can be as high as 50%.
