Meridian Bioscience (VIVO) Announces Portfolio Expansion, First ASR Products Launch
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Meridian Bioscience, Inc. (Nasdaq: VIVO) announced the launch of their Analyte Specific Reagent (ASR) product line. The first ASR products include a primer set and probes for detection of Helicobacter pylori and the target sequence associated with Clarithromycin-resistant H. pylori strains.
Richard L. Eberly, President, Chief Commercial Officer stated, “As a consistent innovator and market share leader for in vitro diagnostic devices, it is important that Meridian’s diagnostic tools for emerging pathogens be made available early so that evaluations and validations can be undertaken by our customers as they recognize the coming needs of their labs. We are committed to growing our presence in the clinical market by expanding our menu of products to include ASRs and other early stage diagnostics. In the future, we expect to introduce additional ASRs as we expand this product line.”
ASRs are used by laboratories to develop and validate their own tests. In the United States there are no commercially available in vitro diagnostic products for the identification of Clarithromycin-resistant strains; therefore, Meridian’s ASRs address an unmet need, allowing laboratories to develop their own tests.
Helicobacter pylori and Helicobacter pylori Clarithromycin-resistant probes and primers are now available for immediate ordering through Bioline, a wholly-owned subsidiary of Meridian Bioscience, Inc. Meridian’s ASRs are manufactured under strict GMP controls to meet the growing demand for building blocks with a guarantee of purity. In compliance with US regulations, ASRs can only be sold to clinical laboratories regulated under CLIA 1988 as qualified to perform high complexity testing under 42 CFR part 483 or under VHA directive 1106.
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