Company Overview of AdvanDx, Inc.
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...
Woburn, MA 01801
Founded in 2002
Key Executives for AdvanDx, Inc.
Chief Executive Officer and Director
Compensation as of Fiscal Year 2014.
AdvanDx, Inc. Key Developments
AdvanDx, Inc. Announces Data from Thirteen Studies Highlighting AdvanDx's Infectious Disease Assays
May 16 14
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)
Mar 18 14
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
Nov 19 13
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.
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March 31, 2014