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July 06, 2015 8:48 AM ET

Biotechnology

Company Overview of AdvanDx, Inc.

Company Overview

AdvanDx, Inc. 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 components for performing QuickF...

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: 63
Founder, President and Director
Founder, Vice President of Research & Development and Director
Chief Technology Officer
Director of Marketing
Compensation as of Fiscal Year 2015.

AdvanDx, Inc. Key Developments

AdvanDx, Inc. Receives FDA 510(K) Clearance for mecA XpressFISH

AdvanDx, Inc. announced that it has received U.S. Food and Drug Administration 510(k) clearance for its new mecA XpressFISH(TM) assay for the detection of methicillin-resistant and methicillin-susceptible Staphylococcus aureus (MRSA & MSSA) direct from blood culture samples. This phenotypic mRNA-targeting approach makes mecA XpressFISH unique in its mechanism of MRSA identification. mecA XpressFISH also provides results hours or days sooner than conventional laboratory methods which often require 48-72 hours. Drug resistance in MRSA is commonly conferred through expression of the bacterial mecA gene. mecA XpressFISH is a qualitative fluorescence in situ hybridization (FISH) assay that utilizes peptide nucleic acid (PNA) probes to bind and detect mecA messenger RNA (mRNA) sequences in blood cultures from patients infected with Staphylococcus aureus. Positive detection requires that the cells contain a functioning mecA gene.

AdvanDx, Inc. Announces Data from Thirteen Studies Highlighting AdvanDx's Infectious Disease Assays

AdvanDx, Inc. announced that data from thirteen studies will be presented at the General Meeting for the American Society for Microbiology beginning on May 17 in Boston, Massachusetts. Four of the studies will present data on mecA XpressFISH(TM) (FDA clearance pending), a novel method for the rapid detection of methicillin-resistant Staphylococcus aureus (MRSA) from positive blood cultures. AdvanDx recently submitted its mecA XpressFISH assay to the U.S. Food and Drug Administration for 510(k) clearance. In addition, five studies will present data on the Company's QuickFISH products: Staphylococcus QuickFISH (FDA cleared; CE-IVD); Enterococcus QuickFISH (FDA cleared; CE-IVD); Gram-Negative QuickFISH (FDA cleared; CE-IVD); and QuickFISH Candida (CE-IVD).

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.

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