Meridian Bioscience Announces FDA Submission for New Curian® Campy Assay
On April 1, 2021, Meridian Bioscience announced a 510(k) submission to the FDA for its new Curian® Campy assay, enhancing its gastrointestinal testing offerings. The assay detects Campylobacter spp. in human stool and aims to streamline testing processes with rapid, objective results. Meridian positions the Curian® platform as a leading solution, reducing user variability in test interpretation. This move strengthens Meridian's role in the diagnostic testing market, essential for healthcare systems focusing on gastrointestinal diseases.
- 510(k) submission to FDA for Curian® Campy assay expands product offerings.
- Rapid, objective results from Curian® enhance testing accuracy and reduce subjectivity.
- None.
CINCINNATI, April 01, 2021 (GLOBE NEWSWIRE) -- Meridian Bioscience, Inc. (NASDAQ: VIVO) a leading global provider of diagnostic testing solutions and life science raw materials, today announced that it has made a 510(k) submission to the U.S. Food and Drug Administration (FDA) for the Company’s new Curian® Campy assay. This assay is one of many assays in the pipeline that expands the Curian® menu, continuing Meridian’s leadership in the gastrointestinal disease and lateral flow testing market.
Curian® Campy, for use with the Curian® Analyzer, is a rapid, qualitative fluorescent immunoassay for the detection of Campylobacter spp. (C. jejuni / C. coli / C. upsaliensis / C. lari) in human stool. The stool sample may be either unpreserved or preserved in Cary-Blair-based transport media.
The Curian® solution provides objective, rapid test results and helps to eliminate subjectivity by reducing user variability related to interpreting and reporting visually-based test results. With a simple workflow and clean, comfortable sample handling, Curian® provides healthcare systems a platform to standardize testing from the industry’s leading experts in stool handling and testing.
For more information on the Curian® platform, please visit https://www.meridianbioscience.com/platform/immunoassay/curian/.
About Meridian Bioscience, Inc.
Meridian is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity that are redefining the possibilities of life from discovery to diagnosis. Through discovery and development, we provide critical life science raw materials used in immunological and molecular tests for human, animal, plant, and environmental applications. Through diagnosis, we provide diagnostic solutions in areas including gastrointestinal and upper respiratory infections and blood lead level testing. We build relationships and provide solutions to hospitals, reference laboratories, research centers, veterinary testing centers, physician offices, diagnostics manufacturers, and biotech companies in more than 70 countries around the world.
Meridian’s shares are traded on the NASDAQ Global Select Market, symbol VIVO. Meridian’s website address is www.meridianbioscience.com.
Contact:
Charlie Wood
Vice President – Investor Relations
Meridian Bioscience, Inc.
Phone: +1 513.271.3700
Email: mbi@meridianbioscience.com
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