Luminex Corporation Receives FDA Clearance and CE Mark for SYNCT Software
AUSTIN, Texas, April 14, 2016 /PRNewswire/ — Luminex Corporation (NASDAQ: LMNX) today announced that its SYNCT™ Software has received both U.S. Food and Drug Administration (FDA) clearance and CE Marking for use with its ARIES® System and NxTAG® assays on the MAGPIX® System. SYNCT Software is middleware that provides access to data and reports through a single interface, and allows for customizable workflows by connecting ARIES® and NxTAG-enabled MAGPIX workstations in the lab.
Specifically designed for molecular laboratories running ARIES® and NxTAG assays, SYNCT empowers laboratory directors by offering a streamlined workflow, enhanced data management, and the ability to easily add new functionality. From anywhere in the lab, users can create and prepare orders or manage results from all next-generation Luminex instruments, allowing for division of labor and flexibility to work within any lab process connected to SYNCT. Centralized reporting allows for higher-quality results because data can be accumulated in one place and overseen by the laboratory director. Labs with multiple locations can use SYNCT Software to route all results to a single reviewer, anywhere on the lab network, before sending to the lab information system.
“SYNCT is efficient software for our daily workflow,” said Tong Her, Medical Laboratory Scientist, Test Development and Validation, St. John Hospital and Medical Center. “The order management menu makes it easy to order tests and the ‘run report’ tool allows for simple interpretation of test results.”
Optional applications that provide more functionality and value can easily be added with minimal validation effort. As an example, the ARIES® UDP (User Defined Protocol) App enables customers to create assay protocol files for running analyte specific reagents or customer developed primers in laboratory developed tests.
“Challenges associated with software and information systems that don’t talk to each other waste precious time that lab directors would rather spend maximizing efficiency and ensuring the most accurate and reproducible results from their lab,” said Eric Shapiro, Vice President, Global Marketing at Luminex Corporation. “We are proud to offer our molecular lab customers a better way to manage their data while reducing operational costs.”
About the ARIES® System
The ARIES® System is a sample to answer molecular diagnostic system designed to increase laboratory efficiency, ensure result accuracy, and fit seamlessly into today’s lean laboratory environment. ARIES® uses internal barcode scanning and other advanced features to minimize operator errors. Two independent modules each support from one to six cassettes, allowing for both STAT and Batch testing of IVD and homebrew assays using MultiCode® Reagents when using a common Universal Assay Protocol. An integrated touchscreen PC eliminates the need for a separate computer, standalone keyboard, and mouse, maximizing valuable bench space. Learn more about connecting the ARIES® System to your LIS.
About NxTAG
NxTAG Respiratory Pathogen Panel is CE-marked in Europe, and FDA-cleared in the U.S. NxTAG Respiratory Pathogen Panel is an assay that detects relevant viral and bacterial respiratory pathogens, including the atypical bacteria Chlamydophila pneumoniae and Mycoplasma pneumoniae. The panel is the only respiratory assay that enables laboratories to easily and simultaneously detect these respiratory pathogens in a single, closed tube system and in a format that scales to accommodate changes in throughput needed to respond to seasonal changes in demand, especially during flu season. NxTAG Respiratory Pathogen Panel requires only minutes of hands-on time with no upstream reagent preparation. The innovative tube strip design offers laboratories the flexibility to process a single sample or up to 96 samples per run, without wasting consumables or reagents. Total turnaround time is only about three hours for 96 samples (excluding extraction).
About Luminex Corporation
Luminex is committed to applying its passion for innovation toward creating breakthrough solutions to improve health and advance science. The company is transforming global healthcare and life-science research through the development, manufacturing and marketing of proprietary instruments and assays utilizing xMAP® open-architecture multi-analyte platform, MultiCode® real-time polymerase chain reaction (PCR), and multiplex PCR-based technologies, that deliver cost-effective rapid results to clinicians and researchers. Luminex’s technology is commercially available worldwide and in use in leading clinical laboratories, as well as major pharmaceutical, diagnostic, biotechnology and life science companies. Luminex is meeting the needs of customers in markets as diverse as clinical diagnostics, pharmaceutical drug discovery, biomedical research including genomic and proteomic research, personalized medicine, biodefense research and food safety. For further information on Luminex Corporation and the latest advances in multiplexing using award-winning technology, please visit http://www.luminexcorp.com/.
