ELITechGroup Inc, Bothell, Wash, a provider of molecular diagnostic testing solutions, has received FDA premarket notification (510(k)) clearance to market its HSV 1&2 ELITe MGBreal-time PCR assay with the company’s ELITe InGenius sample-to-result instrument.
The new molecular test detects and differentiates the nucleic acid of herpes simplex viruses 1 and 2 isolated from swab specimens from cutaneous (skin) or mucocutaneous (genital, lips, mouth) lesions on symptomatic patients. The assay provides a real-time polymerase chain reaction-based ready-to-use reagent, and incorporates the company’s proprietary minor groove binder 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. It can perform up to 12 tests per run, with hands-on time of less than 2 minutes per sample.
The ELITe MGBHSV 1&2 assay distinguishes between HSV-1, the virus most associated with cold sores and some genital herpes cases, and HSV-2, which is responsible for most genital herpes infections. The Centers for Disease Control and Prevention (CDC) estimates 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 MGBHSV 1&2 assay and ELITe InGenius sample-to-results instrument,” says 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 MGBHSV 1&2 assay is ELITechGroup’s first 510(k)-cleared assay on the ELITe InGenius instrument and is now available for sale in the United States and Europe. The test joins a number of reagents offered by the ELITechGroup and available for use on the ELITe InGeniusplatform.
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 touchscreen and offers sample and reagent tracking as well as a laboratory information management system 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.
For further information, visit ELITechGroup.
- 1. Genital Herpes: CDC Fact Sheet [online]. Atlanta: Centers for Disease Control and Prevention, 2017. Available at: cdc.gov/std/herpes/stdfact-herpes.htm. Accessed December 18, 2018.