Meridian Bioscience Announces FDA-Clearance for New Curian™ Analyzer and the Curian™ HpSA® Assay
March 16 2020 - 8:00AM
Meridian Bioscience, Inc. (NASDAQ: VIVO) a provider of immunoassay,
molecular, and blood chemistry diagnostic testing solutions, today
announced that it has received FDA-clearance for Meridian’s new
Curian™ and Curian™ HpSA® assay. This analyzer and first assay play
an important part in their initiative to maintain leadership in the
gastrointestinal disease testing market.
Curian and Curian HpSA are designed to quickly
detect Helicobacter pylori antigens in human stool using
immunofluorescent technology. Curian HpSA is intended to aid in the
diagnosis of H. pylori infection and to demonstrate loss of H.
pylori antigen following treatment (i.e., confirmation of
eradication). With a simple workflow and clean, comfortable sample
handling; Curian HpSA provides healthcare systems a platform
looking to standardize H. pylori testing from the industry’s
leading experts in stool handling and testing.
The immunofluorescent technology of the Curian
platform provides an objective, rapid H. pylori result with
state-of-the-art clinical sensitivity, specificity, and a lower
limit of detection than traditional rapid immunoassay testing.
Combined with LIS connectivity, the Curian solution helps to
eliminate subjectivity by reducing user variability related to
interpreting and reporting visually based test results. “This
is the first new platform internally developed at Meridian in
several years,” said Dr. Larry Mertz, Senior Vice President of
Research and Development / Clinical, “and the first of many new
products we have in the pipeline continuing Meridian’s rich history
of innovation.”
Meridian Bioscience offers an unparalleled H.
pylori portfolio that accommodates any laboratory setting from low
volume rapid testing to high volume automation, including the
LIAISON® Meridian H. pylori SA test. Jack Kenny,
Chief Executive Officer, commented “Curian offers both competitive
performance and reduced subjectivity with only a three-step
workflow. This is yet another step Meridian is taking toward
providing diagnostic platforms for healthcare systems looking to
standardize testing, improve patient outcomes, and increase
clinician satisfaction rates.”
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 WoodVice President of Investor
RelationsMeridian Bioscience, Inc.Phone: 513.271.3700Email:
mbi@meridianbioscience.com
Meridian Bioscience (NASDAQ:VIVO)
Historical Stock Chart
From Jul 2024 to Aug 2024
Meridian Bioscience (NASDAQ:VIVO)
Historical Stock Chart
From Aug 2023 to Aug 2024