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AdvanDx Launches New Tools for Detecting Antibiotic Resistance and Virulence Markers in the Highly Aggressive, Community-Acquired MRSA 'Superbug'

Posted on: Monday, 12 June 2006, 06:00 CDT

WOBURN, Mass., June 12 /PRNewswire/ -- AdvanDx announces that at the recent American Society for Microbiology (ASM) meeting in Orlando, Florida, EVIGENE(TM) kits (http://www.evigene-test.com/) for detecting specific antibiotic resistance, virulence, and toxicity markers such as methicillin- resistance, vancomycin-resistance, PVL and TSST-1 in Staphylococcus aureus and enterococci, were launched for research use only in the United States. EVIGENE was officially launched for clinical use in Europe in April, 2006 at the 16th European Congress on Clinical Microbiology and Infectious Diseases (ECCMID) conference in Nice, France.

EVIGENE(TM) kits can be used for epidemiological purposes and help guide infection control measures to prevent serious infections with antibiotic resistant bacteria such as MRSA [(Methicillin-resistant S. aureus) http://www.cdc.gov/ncidod/dhqp/ar_mrsa.html], VRE [(Vancomycin-resistant enterococci) http://www.cdc.gov/ncidod/dhqp/ar_vre.html] and VRSA [(Vancomycin-resistant S. aureus) http://www.cdc.gov/ncidod/dhqp/ar_visavrsa.html].

The tools will also help US researchers develop the means by which to combat the high-profile, community-acquired MRSA (CA-MRSA) "superbug" that is causing serious infections in otherwise healthy adults and children. [See PVL EVIGENE below and link to a USA Today article here: http://www.usatoday.com/news/health/2006-05-10-superbugs-staphylococcus_x.htm

Increasing antibiotic use, especially the widespread overuse of methicillin and vancomycin, has led to the evolution of antibiotic resistant bacteria such as MRSA, VRE and VRSA that are more virulent and cause more severe infections. This has led the CDC to issue specific warnings about the problem Click the following link to see CDC warning: http://www.ohsaa.org/medicine/staph.htm and is forcing hospital infection control and physicians to better understand the infectious bacteria they encounter and develop new strategies for combating them.

Dr. Henrik Stender, Vice President for Research & Development and co- founder of AdvanDx said, "We are very pleased to offer the new EVIGENE(TM) platform for rapid characterization of gene markers in pathogens. Whereas our PNA FISH(TM) products provide rapid speciation, EVIGENE provides a further characterization and classification of the more pathogenic strains. We hope that this information is useful to researchers in the US, and to clinical providers in Europe."

EVIGENE is a qualitative hybridization assay based on nucleic acid signal amplification that provides rapid (3 hrs.) detection of specific gene markers in S. aureus and enterococci isolates.

Clinical Data from 106th ASM General Meeting (Orlando, Florida)

Data presented at the 106th ASM General Meeting demonstrated the high sensitivity and specificity for all available EVIGENE kits.(1)

Two separate posters presented by the CDC (Atlanta, Georgia) and Cedars- Sinai Medical Center (Los Angeles, California) demonstrated high sensitivity (100% and 100% respectively) and specificity (93% and 100% respectively) for PVL EVIGENE in detecting PVL-positive MRSA and MSSA isolates.(2),(3)

Another poster presented by the CDC showed the ability of VRE EVIGENE to detect all six known VRSA (Vancomycin-resistant S. aureus) isolates found thus far in the United States with 100% sensitivity and 100% specificity.(4)

For more information and publication reprints please contact: Henrik Stender, Ph.D. Vice President for Research & Development Phone: +1-781-376-0009 E-mail: news@advandx.com http://www.evigene-test.com/ PVL - Panton-Valentine leukocidin

PVL [(Panton-Valentine leukocidin) http://www.cdc.gov/ncidod/EID/vol9no8/03-0089.htm] is a virulence factor closely associated with community-acquired MRSA. 80-90% of Community-Acquired MRSA are PVL-positive. S. aureus and MRSA have long been recognized as leading causes of hospital-acquired infections, but cases of community-acquired MRSA (CA-MRSA) causing aggressive and difficult to treat infections, even in otherwise healthy adults and children, are on the rise worldwide.

Panton-Valentine leukocidin (PVL) is a cytotoxin virulence factor associated with severe, rapidly progressive, systemic disease including soft tissue infections and necrotizing pneumonia. While PVL is mostly associated with CA-MRSA, PVL positive strains are showing up more frequently in hospitalized patients causing serious infections and requiring more hospitals to develop strategies to detect and control the bacteria.(5)

PVL EVIGENE(TM) (http://www.advandx.com/) provides rapid and accurate identification of PVL-positive S. aureus strains via detection of the lukS- lukF-PV genes.

MRSA - Methicillin-Resistant S. aureus

In the United States more than 60% of S. aureus isolates are now methicillin-resistant, resulting in significant costs to the healthcare system and greater use of vancomycin at the first hint of infection with a Gram- positive cocci.(6),(7)

Effective programs to control the spread of MRSA include rapid identification methods as part of active surveillance programs, aggressive intervention once MRSA is identified, as well as an active antibiotic utilization program.(8)

MRSA EVIGENE(TM) (http://www.advandx.com/default.asp?id=7681) provides rapid and accurate identification of MRSA via detection of the mecA gene from S. aureus isolates.

TSST-1 - Toxic Shock Syndrome Toxin(1)

Menstrual Toxic Shock Syndrome (mTSS) is associated with menstruation and tampon use and is generally thought to be caused by S. aureus producing TSST- 1. The infection can lead to major systemic effects including fever, hypotension, skin lesions, shock, multiorgan failure, and death and requires immediate and aggressive therapy.

While the incidence of mTSS is rather low, the volume use of tampons and the severity of TSST-1 positive S. aureus infections warrants further investigation into its pathogenicity and disease epidemiology.(9)

TSST-1 EVIGENE(TM) (http://www.advandx.com/) provides rapid and accurate identification of TSST-1 positive S. aureus strains via detection of the tst gene.

VRE - Vancomycin-Resistan Enterococci

Enterococci are bacteria normally present in the human intestine and are spread via direct contact with stool, urine, or blood. While virtually unknown in the United States until the early 1990s, VRE now represents a leading cause of hospital-acquired infections, with over 30% of all enterococci infections in hospital intensive care units due to VRE; likely a result of increased vancomycin usage.(6),(10)

While several genes, including vanA, vanB, vanC, vanD, and vanE, contribute to resistance to vancomycin in enterococci, vanA and vanB are considered to be associated with clinical manifestations of VRE. The vanA gene has even been detected in isolates of vancomycin-resistant S. aureus (VRSA), further stressing the need for rapid and accurate methods for detecting the genetic markers in bacteria.(10),(11)

VRE EVIGENE(TM) (http://www.advandx.com/) provides rapid and accurate detection of the vanA/vanB genes from isolates of enterococci and S. aureus.

About AdvanDx

AdvanDx, Inc. develops and markets in vitro diagnostic kits based on its PNA FISH(TM) and EVIGENE(TM) technologies to aid the diagnosis and prevention of infectious diseases. The PNA FISH and EVIGENE product lines provide rapid identification results for bacteria and yeast to support appropriate antibiotic therapy and overall patient care. Headquartered on the 128 technology highway around Boston, AdvanDx has established R&D facilities both in the United States and Denmark with sales and marketing capabilities located throughout the United States and Europe. For more information please visit http://www.advandx.com/ or call +1-781-376-0009.

(1) Rasmussen, K., et al. EVIGENE(TM) Array for Rapid Identification of Antibiotic Resistance (MRSA and VRSA) and Virulence Factors (PVL and TSST-1) of Staphylococcus aureus. Poster C-062. 106th ASM General Meeting. Orlando, Florida. (2) Limbago, B.A., et al. Evaluation of the AdvanDx PVL EVIGENE(TM) Kit for Use Detecting the PVL Locus in Staphylococcus aureus. Poster C- 061. 106th ASM General Meeting. Orlando, Florida. (3) Guintu, R.C., et al. Rapid Identification/Detection of Panton- Valentine Leukocidin (PVL) Gene in Staphylococcus aureus using PVL EVIGENE(tm) (AdvanDx). Poster C-063. 106th ASM General Meeting. Orlando, Florida. (4) Fosheim, G.E., et al. Evaluation of the AdvanDx VRE Evigene(TM) Kit for Use in Detecting Vancomycin-Resistant Staphylococcus aureus. Poster C-114. 106th ASM General Meeting. Orlando, Florida. (5) Gorwitz et al. Summary of an experts' meeting convened by the Centers for Disease Control and Prevention. 2006. Available at http://www.cdc.gov/ncidod/dhqp/ar_mrsa_ca.html. (6) NNIS System. http://www.cdc.gov/ncidod/dhqp/pdf/ar/ICU_RESTrend1995-2004.pdf (7) Shah et al. Curr Med Res Opin. 2004 Jun; 20(6): 779-90. (8) Bootsma et al. Proc Natl Acad Sci U S A. 2006 Mar 24 (9) Parsonnet et al. J Clin Microbiol. 2005 Sep; 43(9):4628-34. (10) Arthur M, Reynolds P, Courvalin P. Glycopeptide resistance in enterococci. Trends Microbiol 1996; 4:401-7 (11) MMWR Report, July 5, 2002 / 51(26); 565-567. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5126a1.htm

AdvanDx, Inc.

CONTACT: For more information and publication reprints - Henrik Stender,Ph.D., Vice President for Research & Development for AdvanDx, +1-781-376-0009,news@advandx.com, or Joen Johansen of AdvanDX, +1-781-376-0009

Web site: http://www.evigene-test.com/http://www.advandx.com/

Source: PRNewswire

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