Luminex Corporation announced that it has received CE-IVD marking for the ARIES System and ARIES HSV 1&2 Assay. The ARIES System and ARIES HSV 1&2 Assay previously received FDA clearance in October 2015 and were subsequently launched in the US market.
ARIES is a sample to answer system crafted to increase laboratory efficiency, produce accurate results, and fit seamlessly into today's lean laboratory environment.
"We are excited to have received a CE-IVD mark for the ARIES System and ARIES HSV 1&2 Assay and look forward to rapidly launching this revolutionary system in Europe," said Thomas Pracht, managing director, EMEIA, Luminex Corporation. "We believe that ARIES will answer many of our clinical laboratory customers' needs to increase efficiency and reduce errors while delivering accurate and timely data to improve patient care."
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, maximising valuable bench space.
The ARIES HSV 1&2 Assay is a real-time polymerase chain reaction (rt-PCR) based qualitative in vitro diagnostic test for the direct detection and typing of herpes simplex virus (HSV 1&2) DNA in cutaneous or mucocutaneous lesion specimens from symptomatic patients, or in cerebrospinal fluid (CSF) from patients suspected of HSV infections of the central nervous system. The test is indicated for use with symptomatic individuals to aid in the diagnosis of HSV infections. The assay is not intended to be used for prenatal screening. The ARIES HSV 1&2 Assay is indicated for use on the ARIES System.
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. In addition, HSV 1&2 are common causes of viral meningitis and encephalitis, which are inflammation of the membranes surrounding the brain and spinal cord or brain, respectively. 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.