Meridian submits Curian™ analyzer and the Curian™ HpSA assay to the FDA
November 06 2019 - 7:30AM
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.
Contact: Jack Kenny Chief Executive Officer
Meridian Bioscience, Inc. Phone: 513.271.3700
Email: mbi@meridianbioscience.com
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