April 20, 2014 8:03 PM ET

Biotechnology

Company Overview of AdvanDx, Inc.

Company Overview

AdvanDx, Inc., a diagnostics company, provides molecular diagnostic tests for the identification of pathogens causing critical infections in hospitalized patients. The company specializes in the molecular testing of positive blood cultures that enable clinical microbiology labs to report pathogen identification results earlier than with conventional testing methods. It offers QuickFISH and PNA FISH tests for the identification of bacteria and yeast directly from positive blood cultures; and PNA Probes for ribosomal RNA sequences found in bacteria and fungi. The company also offers a starter system; accessories, such as microscope slides, cover slips, control slides, and PNA FISH kit componen...

400 TradeCenter

Woburn, MA 01801

United States

Founded in 2002

Phone:

781-376-0009

Fax:

781-376-0111

Key Executives for AdvanDx, Inc.

Chief Executive Officer and Director
Age: 61
Chief Financial Officer
Age: 42
Chief Technology Officer
Compensation as of Fiscal Year 2013.

AdvanDx, Inc. Key Developments

AdvanDx, Inc. Announces FDA 510(K) Submission for mecA XpressFISH(TM)

AdvanDx announced that it has submitted to the U.S. Food and Drug Administration for 510(k) clearance its new mecA XpressFISH(TM) test for the rapid detection of methicillin-resistant Staphylococcus aureus (MRSA) from S. aureus positive blood cultures. This assay will provide physicians with a new way to rapidly identify MRSA enabling them to implement appropriate treatment for patients with bloodstream infections. Methicillin-resistant Staphylococcus aureus (MRSA) is resistant to antibiotics commonly used to treat ordinary staphylococcal infections. An estimated 80,461 invasive MRSA infections occurred in the U.S. in 2011. Of these, 48,353 were healthcare associated community onset infections; 14,156 were hospital-onset infections; and 16,560 were community-associated infections. Methicillin-resistance is almost exclusively caused by the presence and expression of the mecA gene that encodes a unique penicillin-binding protein (PBP2a) that has low affinity for methicillin and other b-lactam drugs. mecA XpressFISH is a qualitative fluorescence in situ hybridization (FISH) assay that utilizes peptide nucleic acid (PNA) probes hybridizing to mecA messenger RNA (mRNA) sequences on smears from blood cultures containing Staphylococcus aureus (SA). This "phenotypic" mRNA-targeting approach makes XpressFISH unique in its mechanism of MRSA identification. Although identification of MRSA is used to guide effective therapy, conventional laboratory methods can take 48 hours to determine whether S. aureus bacteria are resistant. mecA XpressFISH will enable laboratories to rapidly detect MRSA directly from S. aureus positive blood cultures in about an hour. The rapid determination of MRSA by mecA XpressFISH should enable clinicians to prescribe more effective appropriate therapy sooner for MRSA-infected patients. mecA XpressFISH is the latest addition to AdvanDx's easy-to-use, molecular-based diagnostics platform that provides rapid identification of bloodstream pathogens in minutes instead of days. AdvanDx also markets the QuickFISH platform for rapid identification of Gram-positive and Gram-negative bacteria as well as PNA FISH for Candida species.

AdvanDx Launches Candida QuickFISH

AdvanDx announced that it has launched the Candida QuickFISH, a new CE Marked 20-minute rapid diagnostic that can identify up to three Candida species, including C. albicans, C. glabrata, and C. parapsilosis, directly from yeast-positive blood cultures. The nucleic acid–based test enables the microbiologist to report pathogen-identification results 2 to 5 days earlier than conventional methods, aiding clinicians in selecting appropriate antifungal therapy for candidemia patients. QuickFISH Features: QuickFISH is a new, 2nd-generation, molecular-based, rapid diagnostic platform, developed by AdvanDx based on its clinically proven, molecular PNA FISH technology. The new rapid diagnostics enable unprecedented species identification of bacteria and yeast directly from positive blood cultures, allowing pathogen-ID and Gram-stain reporting simultaneously. 5-minute hands-on time: Simplifies laboratory workflow. 20-minute turnaround time: Reported out with Gram-stain results. Built-in, universal controls: Streamlines quality assurance. Minimal instrumentation: Easy start-up.

AdvanDx, Inc. Adds Gram-Negative BC Assay to U.S. and E.U. Commercial Launch of QuickFISH BC

AdvanDx, Inc. announcef the commercial launch of Gram-NegativeQuickFISH BC. Gram-Negative QuickFISH BC is a new rapid molecular diagnostic test that identifies potentially life threatening bloodstream infections caused by Escherichia coli, and/orPseudomonas aeruginosa and/orKlebsiella pneumoniae, within 20 minutes of a positive blood culture, making it the fastest method of identifying gram-negative species in positive blood cultures on the market. The new gram-negative assay is immediately available and further expands AdvanDx's QuickFISH Platform that can now identify the pathogens responsible for 90% of positive blood cultures.[1] Today's announcement of the commercial launch of Gram-Negative QuickFISH BC adds to AdvanDx's two gram-positive QuickFISH tests: Staphylococcus QuickFISH BC for the identification of Staphylococcus aureus and/or coagulase-negative staphylococci; and Enterococcus QuickFISH BC, for the identification of Enterococcus faecalis and/or selected other enterococci. AdvanDx anticipates commercial launch of the fourthQuickFISH assay for identification of Candida species from positive blood cultures in the second half of 2013, following regulatory clearance. Gram-negative bloodstream infections, especially those caused by Pseudomonas aeruginosa, are associated with high mortality rates and can be difficult to treat due to increasing resistance to antimicrobial agents. Traditional laboratory testing methods take 24 to 48 hours or longer to identify the causative pathogen, forcing clinicians to treat patients based on limited information. This presents a challenge for the health care provider as the decision to add an anti-pseudomonal drug should ideally be based primarily on knowledge of the infecting species. As a result, patients with gram-negative bloodstream infections are often either subjected to broader than necessary antimicrobial therapies, which may be toxic and may promote the development of drug resistance, or they may be undertreated, increasing their risk for adverse outcomes. QuickFISH is a new, rapid, molecular diagnostic platform developed by AdvanDx based on its clinically- proven, proprietary PNA technology. The new platform enables unprecedented (20 minute) species identification of bacteria directly from positive blood cultures, allowing the reporting of pathogen identification at the same time as the reporting of Gram stain results.

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