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. Meridian Bioscience advises 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.
Meridian Bioscience notes 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.”