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EliTech Herpes Simplex Virus Assay, Sample-to-Answer Instrument Get FDA Clearance

NEW YORK (GenomeWeb) – Molecular diagnostics maker EliTech Group has received 510(k) clearance from the US Food and Drug Administration for a sample-to-results diagnostic instrument and an assay to detect and differentiate herpes simplex viruses 1 and 2.

The instrument and assay are now commercially available in the US, the firm said.

The ELITe MGB HSV 1&2 Assay is cleared for use on swab specimens from cutaneous or mucocutaneous lesions in symptomatic patients with cold sores or genital herpes.

The diagnostic instrument, called the Elite InGenius, is a fully automated benchtop instrument that performs real-time PCR-based testing on 12 tests in a run, requiring two minutes of hands-on time per sample.

The instrument integrates extraction, amplification, and results interpretation, and is also an open platform compatible with commonly used fluorescent probes. It contains 12 independent thermal cyclers that can run different PCR profiles in each run, with six detection channels for multiplex detection. It can also run multiple different assays from a single sample tube.

The instrument can be used in various operational modes, including extraction-only, amplification-only, or full-processing extraction, amplification, and result analysis with melt curve analysis capability.

The Elite InGenius was introduced as a CE-IVD marked instrument in 2015 with a core menu of transplant monitoring assays. The firm also currently markets a menu of CE-marked molecular diagnostics kits for detecting hospital-acquired infections, sexually transmitted diseases, respiratory infections, bacterial and viral meningitis, as well as other research-use assays and reagents. In addition, the EliTech Group manufactures and distributes diagnostic products for clinical chemistry, microbiology, and molecular biology.

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