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AdvanDx Receives FDA 510(k) Clearance for mecA XpressFISH?


WOBURN, Mass., Nov. 18, 2014 /PRNewswire/ AdvanDx, a leader in the development of advanced molecular diagnostic products for the diagnosis and treatment of life-threatening infections, today announced that it has received U.S. Food and Drug Administration 510(k) clearance for its newmecA XpressFISH? assay for the detection of methicillin-resistantand methicillin-susceptible Staphylococcus aureus(MRSA & MSSA) direct from blood culture samples.
This “phenotypic” mRNA-targeting approach makesmecA 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.
“mecA XpressFISH enables clinical microbiology laboratories to definitively identify MRSA and MSSA in about an hour. Rapid results allow for the most appropriate antimicrobial therapy, which will improve patient outcomes and empower antibiotic stewardship programs,” said Dr. Thomas Davis, Director of Clinical Microbiology at Indiana University School of Medicine.
Drug resistance in MRSA is commonly conferred through expression of the bacterialmecAgene. mecA XpressFISH is a qualitative fluorescence in situ hybridization (FISH) assay that utilizes peptide nucleic acid (PNA) probes to bind and detectmecAmessenger RNA (mRNA) sequences in blood cultures from patients infected with Staphylococcus aureus. Positive detection requires that the cells contain a functioning mecA gene.
“It is known that some S. aureus isolates carry an inactive mecA gene,” said Geoffrey A. McKinley, Ph.D., Senior Vice President of R&D and Business Development for AdvanDx. “mecA XpressFISH detects and identifies expression of the gene which will help clinicians determine if the infection is resistant to commonly used, well tolerated drugs. The test will guide caregivers to the best course of antibiotic treatment, discontinuing the use of broad spectrum antibiotics for patients with routine Staphylococcus aureus infections.”
MRSA infections kill thousands of people annually. Approximately 12,000 people died of MRSA in the United States in 2011 according to the Center for Disease Control. Unlike MRSA, MSSA can be treated with a number of commonly used and well-tolerated antibiotics. Physicians must be able to distinguish MRSA from MSSA in order to determine the most appropriate therapy for their patients.
About AdvanDx
AdvanDx develops advanced molecular diagnostic products for the diagnosis and treatment of life-threatening infections. Its proprietary technology platform enables the creation of molecular diagnostic product families which rapidly deliver clinically actionable microbiological information that improves patient health outcomes, while reducing healthcare costs and unnecessary antibiotic use. The company has three product families: PNA FISH, 90-minute pathogen ID; QuickFISH, 20 minute pathogen ID; and XpressFISH, 70 minute mecA resistance ID. Merck Global Health Innovation Fund, SLS Invest AB, and LD Pensions are investors in AdvanDx. For more information

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