NORTHBROOK, IL September 19, 2013 -- Nanosphere, Inc. (NASDAQ: NSPH)
- Announces support for CDC report on antibiotic resistance in the United States
- Submits Gram-Negative Blood Culture Test to FDA that will expand its infectious disease portfolio
Nanosphere, Inc., a company enhancing medicine through targeted molecular diagnostics, today announced its support of the Centers for Disease Control and Prevention (CDC) first-ever report on antibiotic resistance threats in the United States, issued earlier this week.
Every year, more than two million people get antibiotic-resistant infections, leading to complications such as sepsis and even death. At least 23,000 deaths are linked to antibiotic resistance each year, and another 14,000 people die due to Clostridium difficile (C. difficile), a diarrheal infection associated with antibiotic use. These infections cost the United States economy as much as $20 billion per year. To curb this threat to human and economic health, the CDC has called for improved antibiotic stewardship and the development of new diagnostic tests to track resistance among other things.
“The CDC landmark report highlights the critical problem of antibiotic-resistant bacteria and calls for action, including the adoption and implementation of diagnostic tests to advance more targeted therapy associated with antibiotic stewardship,” said Michael McGarrity, Nanosphere’s president and chief executive officer. “We believe our growing menu of infectious disease tests has the ability to provide every hospital in the U.S. and globally with this directed capability of more effectively diagnosing and treating patients with these critical infections.”
Nanosphere currently manufactures and markets the FDA-cleared Verigene Gram-Positive Nucleic Acid Blood Culture (BC-GP) and C. difficile Nucleic Acid Tests, which not only rapidly and accurately identify infections like sepsis and C. difficile, but also pinpoint antibiotic resistance, leading to optimized therapy and improved antibiotic stewardship. Studies presented at the recent Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) and General Meeting of the American Society for Microbiology (ASM) showed that clinicians changed therapy more frequently based on Verigene BC-GP test results, leading to more optimized care.
In addition, Nanosphere filed a 510(k) submission with the U.S. Food and Drug Administration (FDA) in early September seeking clearance for theVerigene Gram-Negative Blood Culture Nucleic Acid (BC-GN) Test to aid in the diagnosis of bacterial bloodstream infections. The Verigene BC-GN test simultaneously detects a broad panel of gram-negative bacteria commonly associated with bloodstream infections and the critical genetic markers of antimicrobial resistance, including the KPC and NDM genes, which can identify Carbapenem-resistant Enterobacteriaceae (CRE) and other antibiotic-resistant bloodstream infections.
If cleared, the 14 target panel will further strengthen Nanosphere’s portfolio of rapid molecular bloodstream infection diagnostic tests. The Company has already obtained CE IVD Mark under the European Directive on In Vitro Diagnostic Medical Devices for the Verigene BC-GN test.
About the Verigene[R] System
The Verigene System uses 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 mapping the genome of a particular bacterium. Currently, Verigene assays target infections of the bloodstream, respiratory tract and gastrointestinal tract. The System also offers additional capabilities in cancer, cardiovascular disease and autoimmune disease. The information gathered from Verigene enables clinicians to identify diseases earlier and make informed patient treatment decisions more quickly, which may result in improved patient outcomes, reduced costs, optimized antibiotic therapy, reduced spread of antibiotic resistance and potentially, saved lives.
About Nanosphere, Inc.
Nanosphere is enhancing medicine through targeted molecular diagnostics that result in earlier disease detection, optimal patient treatment and improved healthcare economics. The Company’s versatile technology platform, the Verigene® System, enables clinicians to rapidly detect the most complex, costly and deadly infectious diseases through a low cost and simple-to-use multiplexed diagnostic test. The combination of this innovative technology andNanosphere’s customer-driven solutions keeps commitment to the patient at the forefront of its business. Nanosphere is based in Northbrook, IL. Additional information is available at http://www.nanosphere.us.
Roger Moody, Chief Financial Officer
Michael Rice, LifeSci Advisors
Lindsey Saxon, Director of Communications
Geoff Curtis, Edelman
SOURCE Nanosphere, Inc.