Meridian Bioscience Receives FDA-Clearance for the Curian® Campy Assay

Rhea-AI Summary

Meridian Bioscience, a leader in diagnostic testing, announced FDA clearance for its Curian^® Campy assay on Jan. 5, 2022. This rapid test detects Campylobacter-specific antigens in fecal specimens, providing results in approximately 20 minutes. The assay enhances patient care by delivering accurate and timely results for campylobacteriosis, a common gastrointestinal infection. The Curian testing platform, which includes the newly cleared assay, aims to streamline testing in laboratories, following the prior clearance of the Curian HpSA^® assay in March 2020.

Positive

• FDA clearance of the Curian Campy assay enhances product portfolio.
• Rapid results (20 minutes) improve patient care and laboratory efficiency.
• Expansion of the Curian testing platform strengthens market position.

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• None.

CINCINNATI, Jan. 5, 2022 /PRNewswire/ -- Meridian Bioscience, Inc. (NASDAQ: VIVO), a leading global provider of diagnostic testing solutions and life science raw materials, announced today that the Curian^® Campy assay has received U.S. Food and Drug Administration (FDA) clearance.  The Curian Campy assay is a rapid, qualitative fluorescent immunoassay for the detection of a Campylobacter-specific antigen including C. jejuni, C. coli, C. upsaliensis, and C. lari in human fecal specimens.  The assay was developed to be utilized on the Curian immunofluorescent testing platform. 

Campylobacter infection, also known as campylobacteriosis, is one of the most widespread infectious diseases worldwide.  This gastrointestinal disease presents with symptoms of acute watery or bloody diarrhea, abdominal pain, and fever.  The symptoms usually occur 24 to 72 hours after ingestion, and the disease lasts up to six days.  The Curian Campy assay features an easy workflow and produces objective results in about 20 minutes.  Curian Campy offers clinicians accurate and timely results to deliver appropriate care for patients infected with campylobacteriosis. 

The Curian testing platform centers around the innovative Curian analyzer – a compact immunofluorescent instrument that boasts a simple workflow and clean sample handling to provide a rapid result that eliminates the subjectivity of traditional rapid immunoassay diagnostic tests.  The platform can be easily integrated into any laboratory or healthcare system.  Curian Campy is the second FDA-cleared assay on Meridian's expanding Curian testing platform.  The Curian Analyzer and Curian HpSA^® assay received FDA clearance in March 2020.

"Curian Campy follows last year's successful launch of our Curian HpSA assay and is the next step in expanding our Curian test menu for gastrointestinal infections," stated Wes Lindsey, Ph.D., Vice President Global Research and Development - Diagnostics.  "What is most exciting about this platform is that it paves the way for us to continue to develop easy-to-use lateral flow assays with fluorescent detection on an automated analyzer.  This allows for not only increased sensitivity but eliminates the subjectivity that is inherent when manually reading a lateral flow assay."

To learn more about the Curian testing platform and the Curian Campy assay, please visit www.meridianbioscience.com/curian.  For sales inquiries, please contact Meridian Bioscience at 1-888-763-6769 or sales@meridianbioscience.com. For media inquiries, please contact Charlie Wood at charlie.wood@meridianbioscience.com. 

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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SOURCE Meridian Bioscience, Inc.

FAQ

What is the Curian Campy assay by Meridian Bioscience?

The Curian Campy assay is a rapid, qualitative test for detecting Campylobacter-specific antigens in human fecal specimens.

When did Meridian Bioscience receive FDA clearance for the Curian Campy assay?

Meridian Bioscience received FDA clearance for the Curian Campy assay on January 5, 2022.

How quickly can the Curian Campy assay provide results?

The Curian Campy assay can provide results in approximately 20 minutes.

What infections does the Curian Campy assay help diagnose?

The Curian Campy assay helps diagnose campylobacteriosis, caused by Campylobacter infections.

What other assays are available on the Curian testing platform?

The Curian testing platform also includes the Curian HpSA^® assay, which was cleared in March 2020.