Luminex Corporation Receives Medical Device License
News Feb 23, 2016
Luminex Corporation has announced that it has received medical device licenses from Health Canada's Therapeutic Products Directorate, Medical Devices Bureau for the ARIES® System and ARIES® HSV 1&2 Assay. The ARIES® System and HSV 1&2 Assay previously received FDA clearance in October 2015 and were subsequently launched in the U.S. market.
"We are excited to receive medical device licenses for the ARIES® System and the ARIES® HSV 1&2 Assay in Canada. We look forward to rapidly launching this revolutionary system there," said Todd Bennett, VP, Global Sales and Customer Operations, Luminex Corporation. "We are confident that the ARIES® System will answer many of our Canadian clinical laboratory customers' needs by increasing efficiency, reducing errors, and delivering accurate and timely data to improve patient care."
The ARIES® System is a sample to answer system designed to increase laboratory efficiency, ensure result accuracy, and fit seamlessly into lean laboratory environment. The ARIES® System uses internal barcode scanning and other advanced features to minimize operator errors. The system contains two independent modules that support from one to six cassettes each, allowing for both STAT and Batch testing. IVD and MultiCode® Analyte Specific Reagents can be run simultaneously with a common Universal Assay Protocol.
An integrated touchscreen PC eliminates the need for a separate computer, stand-alone keyboard, and mouse, thus maximizing valuable bench space. The ARIES® System is the most powerful and intuitive of any sample to answer solution and provides control of the testing process, from accession of the sample to results reporting.
HSV-1 is a contagious infection, which is common and endemic throughout the world. The virus causes lifelong infection, and there is no cure, although treatment can reduce symptoms. It is mainly transmitted through oral-oral contact and causes "cold sores." HSV-2 infection is widespread and mainly sexually transmitted. It is estimated that up to 20 million people are newly infected with HSV-2 each year.
HSV-2 causes genital herpes, characterized by the occasional appearance of painful genital ulcers. Prescription antivirals to treat herpes simplex include acyclovir, famciclovir, and valacyclovir. Serious complications occur most often in unborn babies, newborns, and people who have a long-term illness such as cancer or HIV/AIDS, or have a weakened immune system.
Researchers have created a portable and fast-acting test that can distinguish Ebola infections from other fever-causing infectious diseases such as Lassa fever and malaria in around 30 minutes. Although further testing is required, this could be useful during febrile disease outbreaks.READ MORE