×

Twelve Studies Presented at ASM 2014 Highlight New Performance and Clinical Outcome Data Using Select Verigene Infectious Disease Tests

NORTHBROOK, Ill., May 21, 2014 (GLOBE NEWSWIRE) -- Nanosphere, Inc. (Nasdaq:NSPH), a company enhancing medicine through targeted molecular diagnostics, today announced that twelve studies evaluating the performance and clinical impact of select Verigene® multiplex infectious disease tests have been presented at the 114th General Meeting of the American Society for Microbiology (asm2014), held this week in Boston, Massachusetts.

In addition, during the meeting Nanosphere showcased Faces of Sepsis™, a video recently launched by Sepsis Alliance, a non-profit patient advocacy organization, which provides a glimpse into the touching stories of three people whose lives have been affected by sepsis. This video was produced in part with unrestricted support from Nanosphere.

"Antibiotic-resistant bacteria pose a serious threat to human and economic health in the U.S., and significantly complicate the effective treatment of life-threatening infectious diseases like sepsis," said Michael McGarrity, president and chief executive officer of Nanosphere. "We believe our menu of Verigene bloodstream infection tests offers a powerful solution to this growing healthcare challenge, and are pleased with the growing body of clinical evidence that demonstrates the critical impact they can have on the quality of patient care and antimicrobial stewardship efforts in hospitals."

Following are summaries of several of the studies presented. Abstracts for the remaining posters can be found at gm.asm.org.

  • Poster 1141: "De-escalation of Antibiotics in Response to the Nanosphere Verigene Gram-Positive Blood Culture Assay." This study compared patient results and treatment before and after the Verigene Gram-Positive Blood Culture Test (BC-GP) was implemented along with an automated result reporting algorithm that included antibiotic recommendations for the treating doctors. The test led to a 26 hour reduction in the time from sample collection to the first dose of appropriate antibiotics for patients with methicillin-sensitive Staphylococcus aureus (MSSA) and vancomycin-resistant Enterococcus (VRE) infections. Additionally, the percentage of patients placed on targeted therapy within 3 days of collection increased from 62.8% in the pre-implementation group to 81.5% in the post-BC-GP implementation group. The study was conducted at Baylor University Medical Center and med fusion Laboratory (Dallas and Lewisville, TX), led by Dr. S. Beal.
  • Poster 1145: "Comparison of Verigene BC-GP to Peptide Nucleic Acid Fluorescence in situ Hybridization (PNA-FISH) in Conjunction with mecA Gene Detection for Staphylococcus aureus Bacteremia." In this study, each of the 79 S. aureus isolates evaluated was correctly identified by both Verigene BC-GP and PNA-FISH. Verigene BC-GP accurately distinguished methicillin-resistant S. aureus (MRSA) from MSSA in all cases, while mecA gene detection correctly distinguished 78 of 79 cases. Time to pathogen identification and methicillin resistance determination was shortest by Verigene BC-GP and both molecular methods provided more rapid results than the phenotypic method, leading the authors to conclude that use of Verigene BC-GP may lead to improved antibiotic use in patients with S. aureus bacteremia compared to other platforms. The study was conducted at Intermountain Healthcare (Salt Lake City, UT), led by Dr. B. K. Lopansri.
  • Poster 1566: "Evaluation of the Nanosphere Verigene BC-GN for the Identification of Gram-Negative Bacilli and Detection of Antibiotic Resistance Mechanisms Directly from Positive Blood Cultures." In this study, the Verigene Gram-Negative Blood Culture Test (BC-GN) correctly identified 100% of gram-negative bacteria in 33 blood cultures and correctly identified 13 out of 14 carbapenemase resistance markers. Verigene BC-GN decreased the time to bacterial identification by a range of 12 hours 21 minutes to 48 hours 18 minutes when compared to conventional culture methods. In addition, review showed that medical management could have been modified for 7 of 22 patients and the antibiotic change could have been made by an average of 33 hours 26 minutes sooner as compared to acting on the results of conventional culture identification. The study was conducted at Kaiser Permanente Northwest (Portland, OR), led by J.T. Hill.
  • Poster 1568: "Performance of the Nanosphere Verigene BC-GN Assay in an Acute Care Inner-City Hospital." Verigene BC-GN successfully identified the causative pathogen in 100% of the 65 patient cases tested in this study. All resistance determinants were correctly identified based on phenotypic and molecular comparison. In addition, Verigene BC-GN detected organisms that produce the resistance enzyme CTX-M extended-spectrum beta-lactamase (ESBL) in 3% of isolates tested, and identified 1 isolate of Enterobacter species as an ESBL producer that would have otherwise gone undetected by the laboratory. These results led the study authors to conclude that Verigene BC-GN has the potential to detect ESBL and carbapenem resistance determinants routinely encountered at their institution. The study was conducted at Hennepin County Medical Center (Minneapolis, MN), led by Dr. G. Hansen.
  • Poster 1588: "Effects of Blood Volume on the Performance of the Verigene BC-GP Assay in Pediatric Patients." For the 136 pediatric blood cultures tested, Verigene BC-GP correctly identified 123 blood culture bottles with mean blood volume of 1.5 milliliters (mL). For this data set, 93.8% of the bottles containing greater than 3 mL of blood and 90.0% of bottles with blood volume of less than 3 mL were successfully identified by Verigene BC-GP. The 13 discordant results had blood culture bottles with a mean blood volume of 1.7 mL. The authors conclude that obtaining adequate blood volume is an ongoing challenge for the detection of pathogens in bloodstream infections in pediatric patients; however, Verigene BC-GP is highly robust with blood volume having no impact on overall performance and blood volume. The study was conducted at Children's Hospital of Los Angeles, led by Dr. C. M. Polanco.
  • Poster 2533: "Decreasing Turnaround Times in Septic Patients Infected with Carbapenemase Producing Gram-Negative Organisms, a First Look at an Emerging Technology." In this study, sensitivity and specificity of Verigene BC-GN were both 100% for each of the following organisms and carbapenemase-encoding genes: blaOXA23 containing A. baumannii, blaVIM containing C. freundii, blaNDM-1, blaCTX-M-1 containing ATCC BAA2147 K. pneumoniae, blaKPC containing E. cloacae, blaKPC containing E. coli, and blaIMP containing K. pneumoniae. The study was conducted at San Antonio Military Medical Center (Fort Sam Houston, TX), led by E. Steele.

About the Verigene® System

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 blood, 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.

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 and Nanosphere'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.

CONTACT: Investors: Roger Moody, Chief Financial Officer 847-400-9021 rmoody@nanosphere.us Michael Rice, LifeSci Advisors 646-597-6979 mrice@lifesciadvisors.com Media: Lindsey Saxon, Director of Communications 847-400-9173 lsaxon@nanosphere.usSource:Nanosphere, Inc.