Luminex Receives FDA Clearance To Add New Clinical Targets And Additional Sample Type For Use With xTAG® Gastrointestinal Pathogen Panel
This comprehensive syndromic panel tests for greater than 90% of bacterial, viral, and parasitic causes of infectious gastroenteritis in a single molecular test
AUSTIN, Texas, Sept. 29, 2014 /PRNewswire/ -- Luminex Corporation (NASDAQ: LMNX) today announced it has received U.S. FDA clearance to add three new targets to its xTAG® Gastrointestinal Pathogen Panel (GPP). The targets include Adenovirus 40/41, Entamoeba histolytica and Vibrio cholerae. In addition, FDA has now cleared xTAG GPP for use with specimens in Cary-Blair medium, a common transport medium for collection and preservation of microbiological specimens.
"xTAG GPP helps me quickly identify the causes of gastroenteritis by testing for viruses, bacteria and parasites in one test," said Dr. Anami Patel, Director at Le Bonheur Children's Hospital. "Additionally, I have the flexibility to tailor the xTAG GPP test to physician orders which is useful for customizing the panel to different patient populations. Because I can process many samples at one time with the scalable format of xTAG GPP, I can be more efficient in my laboratory testing meeting increased demand when necessary which is especially important in outbreak situations."
As the first multiplexed U.S. IVD cleared test for infectious gastroenteritis, xTAG GPP simultaneously detects 14 common viral, bacterial, and parasitic causative pathogens from a single patient sample. By testing for greater than 90% of the causative pathogens of infectious gastroenteritis in a single test, clinicians can more quickly identify and treat the causative agent. Additionally co-infections can be more easily identified.
Simultaneous molecular testing on a single sample within a single shift also provides significant benefits to laboratories in terms of workflow and resource utilization. The ability to scale throughput by processing 96-well plates allows laboratories to easily tailor their sample processing to physician demand.
"We are dedicated to our customers and strive to continually update and improve our products to advance the delivery of health care," said Patrick J. Balthrop, president and chief executive officer of Luminex. "We are pleased to receive clearance for this new specimen medium and these additional clinical targets which provide even more flexibility to our customers. As laboratories are being asked to do more with less, we are continually working to deliver solutions that meet the varied needs of our customers."
Luminex will be featuring xTAG GPP at Infectious Disease Week, IDSA Annual Meeting, October 8–12 in Philadelphia, PA, Booth #522. For more information on xTAG GPP, please visit Luminex's website at www.luminexcorp.com.
About Gastroenteritis
Infectious gastroenteritis is an inflammation of the stomach and intestines caused by certain viruses, bacteria, or parasites. Common symptoms include vomiting and diarrhea, which can be more severe in infants, the elderly, and people with suppressed immune systems. Gastroenteritis can be spread easily through person-to-person contact, and contaminated food, water, and surfaces.
Diarrheal disease strikes more than two billion times globally each year, and is a leading cause of child morbidity and mortality worldwide(1). In the United States alone, 99 million cases of Gastrointestinal (GI) infection occur annually, leading to more than 250,000 hospitalizations(2) and 17,000 deaths(3)—inflicting a significant toll on the healthcare system. Diagnosis of some causes of infectious gastroenteritis has traditionally required multiple tests across the microbiology, virology, and molecular laboratories for which results may not be available for several days.
For more information visit www.gastroenteritis.com
About xTAG GPP
xTAG Gastrointestinal Pathogen Panel is a multiplexed nucleic acid test for the detection of multiple viral, parasitic, and bacterial nucleic acids in human stool specimens from individuals with signs and symptoms of infectious colitis or gastroenteritis. xTAG GPP detects the following potential causes of gastroenteritis:
| Bacteria: |
|
| Campylobacter |
|
| Clostridium difficile toxin A/B |
|
| Escherichia coli (E. coli) O157 |
|
| Enterotoxigenic E. coli (ETEC) LT/ST |
|
| Salmonella |
|
| Shigella |
|
| Shiga-like Toxin producing E. coli (STEC) stx 1/stx 2 |
|
| Vibrio cholerae, cholera toxin gene (ctx) |
|
| Virus: |
|
| Adenovirus 40/41 |
|
| Norovirus |
|
| Rotavirus A |
|
| Parasite: |
|
| Cryptosporidium |
|
| Entamoeba histolytica |
|
| Giardia |
The detection and identification of specific gastrointestinal microbial nucleic acid from individuals exhibiting signs and symptoms of gastroenteritis aids in the diagnosis of gastrointestinal infection and the investigation of acute gastroenteritis outbreaks when used in conjunction with clinical evaluation, laboratory findings, and epidemiological information. xTAG GPP positive results are presumptive and must be confirmed by FDA-cleared tests or other acceptable reference methods. The assay is cleared on the Luminex® 100/200™ system.
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.
References:
1) http://www.who.int/mediacentre/factsheets/fs330/en/index.html
2) http://www.clevelandclinicmeded.com/medicalpubs/diseasemanagement/gastroenterology/acute-diarrhea
3) http://www.cdc.gov/media/releases/2012/p0314_gastroenteritis.html
Contact:
Luminex Corporate Contact:
Harriss Currie
Sr. Vice President, Finance and CFO
[email protected]
512.219.8020
Media:
Mimi Torrington
Director of Marketing Communications
[email protected]
512.219.8020
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SOURCE Luminex Corporation
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