New FDA-Cleared Assay to Aid in Diagnosis of Inflammatory Bowel Disease

A new quantitative ELISA for calprotectin helps diagnosis inflammatory bowel disease as well as differentiates it from irritable bowel syndrome.

INOVA Diagnostics Inc. (San Diego, CA, USA) has launched QUANTA Lite Calprotectin, an important new FDA-cleared in vitro diagnostic (IVD) assay that aids in the diagnosis of Inflammatory Bowel Disease (IBD) and which can also help differentiate IBD from Irritable Bowel Syndrome (IBS) in conjunction with other clinical findings.

The accurate detection of calprotectin levels in stool can provide critical information to physicians in determining appropriate care for patients suffering from gastrointestinal disorders. QUANTA Lite Calprotectin is a 96-well, quantitative enzyme linked immunosorbent assay (ELISA) that detects calprotectin concentration in human feces.

This assay further expands the INOVA Diagnostics portfolio in the area of autoimmune gastrointestinal disorders. "We are very pleased to launch this high-performing assay to meet the increasing demand from laboratories worldwide," said Michael Mahler, PhD, Vice President of Research and Development for INOVA Diagnostics, "Inaccurate diagnosis at the screening level can contribute to unnecessary procedures and increased healthcare costs. The QUANTA Lite Calprotectin assay can improve patient care while potentially reducing overall costs." Roger Inglès, CEO of INOVA Diagnostics, added, "The benefits of fecal calprotectin testing are being recognized by healthcare systems around the world, as evidenced by the recent recommendation from the National Institute for Health and Care Excellence (NICE) in the UK. As a worldwide leader in the autoimmunity IVD market, INOVA Diagnostics is perfectly positioned to quickly increase awareness and adoption of this important new test."

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