BOTHELL, Wash.--(BUSINESS WIRE)--ELITechGroup Inc., a provider of molecular diagnostic testing solutions, announced today that it has received clearance from the United States Food and Drug Administration (FDA) to market its HSV 1&2 ELITe MGB® Real-Time PCR assay with the ELITe InGenius® sample-to-result instrument. The new molecular test detects and differentiates herpes simplex viruses 1 and 2 nucleic acid isolated from swab specimens from cutaneous (skin) or mucocutaneous (eg., genital, lips, mouth) lesions on symptomatic patients.
ELITechGroup’s molecular assay for HSV 1&2 is a Real-Time PCR ready-to-use reagent, incorporating proprietary Minor Groove Binder (MGB) technology for use on the ELITe InGenius® instrument. The ELITe InGenius® is a fully automated, sample-to-result benchtop molecular diagnostic instrument performing all steps from sample extraction to results analysis that can perform up to 12 tests per run with hands-on time of less than 2 minutes per sample.
The ELITe MGB® HSV 1&2 Assay distinguishes between HSV-1, the virus most associated with cold sores and some genital herpes cases and HSV-2 which is primarily responsible for most genital herpes infections. The Centers for Disease Control and Prevention (CDC) estimate that there are almost 800,000 new cases of herpes in the United States each year, and about 1 in 6 Americans aged 14 to 49 have a genital HSV 2 infection.1
“We are very pleased to receive 510(k) clearance for our ELITe MGB® HSV 1&2 Assay and ELITe InGenius® Sample-to-Results instrument," said Christoph Gauer, chief executive officer of ELITechGroup. "Molecular diagnostics is now the standard of care for infectious disease testing and our platform provides true sample-to-result testing, reducing hands-on time for laboratory technicians while providing the physicians and their patients with accurate and reliable identification of herpes simplex viruses."
The ELITe MGB® HSV 1&2 Assay is ELITechGroup’s first 510(k) cleared assay on the ELITe InGenius® instrument and is now available for sale in the U.S. and Europe. This test joins a number of reagents offered by the ELITechGroup available for use in the ELITe InGenius® platform.
The ELITe InGenius® sample-to-result instrument tests samples from their primary tube with the option to run multiple different tests from one sample at the same time. The system has a touch screen and offers sample and reagent tracking as well as a LIMS (Laboratory Information Management) interface designed for ease of use. ELITechGroup is currently developing additional diagnostic tests utilizing this format. The current 510(k) clearance represents a milestone and a firm commitment to providing molecular diagnostic testing solutions for the clinical laboratory.
About ELITechGroup
ELITechGroup is a privately held group of worldwide manufacturers and distributors of in vitro diagnostic equipment and reagents. By bringing together IVD specialty companies that offer innovative products and solutions, ELITechGroup has become a major contributor in advancing clinical diagnostics to laboratories in the proximity market, those operating closer to the patient. The ELITechGroup manufactures and distributes diagnostic products for clinical chemistry, microbiology, and molecular biology through direct sales and a distribution network encompassing more than 100 countries.
About ELITe InGenius®
ELITe InGenius® is the first sample-to-result solution introduced with a quantitative CE-IVD core menu for transplant pathogen monitoring. ELITe InGenius® is an ease-of-use and highly flexible solution integrating all of the steps of molecular diagnostics: extraction, amplification and results interpretation, in a single platform with best-in-class and proven technologies for nucleic acid extraction and RT-PCR amplification. Built on ELITechGroup expertise to design, optimize and provide efficient PCR solutions for in vitro diagnostic laboratories, the system was CE-IVD marked for IVD applications in Europe in August 2015.
1 http://www.cdc.gov/std/Herpes/STDFact-Herpes.htm