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By achieving certification for the assay, called PredictSure IBD, the Cambridge, UK-based firm can sell it for clinical use across Europe.
Researchers hope that understanding the etiology of inappropriate testing will help them design a better computerized support tool.
The spinout of the University of California, Davis Foods For Health Institute intends the test to be used at the point of care in pediatrician's offices.
The companies aim to develop microbiome diagnostic assays for colon cancer and other gastrointestinal diseases including irritable bowel syndrome.
The assay can be used in conjunction with other laboratory and clinical findings to differentiate IBD from irritable bowel syndrome, the firm said.
The platform, which its developers said is well suited to point-of-care testing, uses fluorescent polymers to distinguish between samples from cases and controls.
Exalenz's systems, the BreathID Hp point-of-care system and the BreathID Hp Lab system, were previously cleared by the FDA for use in detecting H. pylori infection in adults.
The tests detect Campylobacter jejuni and Campylobacter coli and improve upon currently available immunoassays and culture tests, the firm said.
Researchers at Cincinnati Children's Hospital have identified markers for earlier detection of the condition, for which patient outcomes hinge on rapid action.
The company said it will use the proceeds to accelerate development of its gastrointestinal platform, including diagnostics and therapeutics for the GI tract.
The firm said that a number of hospitals and labs are expected to evaluate the panel, presenting it with about a $2.0 million annual revenue opportunity.
The Dutch firm expects its product to be the first commercial test on the market to diagnose IBD by analyzing a patient's gut microbiome.
The firm's GI panel has also been recently evaluated in pediatric populations, demonstrating a marked increase in overall pathogen detection.
Nearly 8,000 patients participated in a screening study that used a PCR-based detection assay from Becton Dickinson, uncovering a 5 percent carrier rate.
On an organic basis, Q1 revenues grew more than 11 percent, driven in part by strong sales of its FilmArray, Vidas, and Vitek product portfolios.
The high-throughput system is now approved with the firm's Blood Culture ID, Gastrointestinal, Meningitis/Encephalitis, and the previously approved Respiratory Panel.