Meridian submits Curian™ analyzer and the Curian™ HpSA assay to the FDA
CINCINNATI, Nov. 06, 2019 (GLOBE NEWSWIRE) — Meridian Bioscience, Inc. (NASDAQ: VIVO) today announced that it has submitted Curian™ and the Curian™ HpSA assay to the FDA for review. This platform and assay are designed to specifically detect Helicobacter pylori antigens in human stool using fluorescent lateral flow technology. Curian™ HpSA is intended to aid in the diagnosis of H. pylori infection and to monitor response during and post-therapy in patients. The addition of this new platform and assay continues to strengthen Meridian’s strategic positioning in the gastrointestinal disease testing market.
Recent studies have shown that Helicobacter pylori infections are a major public health concern globally. According to the CDC, about two-thirds of the global population is infected with H. pylori. H. pylori infection is considered the leading cause for chronic gastritis and is also considered an etiological agent for gastric cancer (adenocarcinoma) and peptic ulcer disease.1-3 H. pylori infection has also been associated with mucosa-associated lymphoid tissue (MALT) and has been attributed to approximately 89% of gastric cancer diagnoses. 1, 4
Lawrence Mertz, Senior Vice President of Research and Development, stated, “We are excited to be the first to develop a rapid fluorescent lateral flow HpSA assay. The use of fluorescent technology coupled with an automated analyzer readout provides a result that can be read without the risk of subjective analysis by the technician.”
Tony Serafini-Lamanna, Global Vice President and General Manager, said, “The submission of Curian and the Curian HpSA assay is yet another strategic move to maintain our leadership and expertise in gastrointestinal diagnostics testing. Curian is an analyzer that will advance rapid GI disease testing, with HpSA being the first of several tests in development.”
- Hooi James KY, Lai Wan Ying, Ng Wee Khoon, Suen Michael MY. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta-Analysis, Gastroenterology. 2017; Vol 153, No. 2.
- Malfertheiner P, Megraud F, O’Morain C, et al. Current concepts in the management of Helicobacter pylori infection: the Maastricht III Consensus Report. Gut 2007;56:772–781.
- Wang C, Yuan Y, Hunt RH. The association between Helicobacter pylori infection and early gastric cancer: a meta-analysis. Am J Gastroenterol. 2007;102:1789–1798.
- International Agency for Research on Cancer Helicobacter pylori Working Group. Helicobacter pylori Eradication as a Strategy for Preventing Gastric Cancer. (IARC Working Group Reports, No. 8). Lyon, France: International Agency for Research on Cancer, 2014. Available from: https://publications.iarc.fr/Book-And-Report-Series/Iarc-Working-Group-Reports/-Em-Helicobacter-Pylori-Em-Eradication-As-A-Strategy-For-Preventing-Gastric-Cancer-2014. Accessed November 18, 2016.
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.
Chief Executive Officer
Meridian Bioscience, Inc.