Cyted snags FDA 510(k) clearance for non-endoscopic esophageal precancer test

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The FDA granted 510(k) clearance to Cyted’s EndoSign, a non-endoscopic capsule sponge device intended to gather pan-esophageal samples for early detection of esophageal cancer as well as other conditions, according to a company release.

“The current paradigm of endoscopy-based screening to prevent esophageal cancer has not decreased the incidence of this deadly disease,” Nicholas J. Shaheen MD, MPH, professor of medicine and chief of the division of gastroenterology and hepatology at the University of North Carolina School of Medicine, said in the release. “Non-endoscopic screening offers a promising, cost-effective new direction to decrease cancer deaths. I am pleased that new modalities such as EndoSign will be available for our patients.”

“Non-endoscopic screening offers a promising, cost-effective new direction to decrease [esophageal] cancer deaths.” ― Nicholas J. Shaheen MD, MPH

EndoSign is part of the Heartburn Health Check program currently used in the United Kingdom, which identifies patients at risk for developing esophageal cancer through early investigation of symptoms such as persistent heartburn and gastroesophageal reflux, the company noted.

“This clearance opens up significant opportunities for Cyted across new geographies and health systems and confirms our device is safe and effective for use in the U.S.,” Marcel Gehrung, CEO and co-founder of Cyted, said in the release. “Combined with novel biomarkers, Cyted’s potential to transform the way patients with chronic reflux are identified and monitored is significant and this clearance is a major step for our expansion.”

Cyted noted that it has also received a $1.3 million grant from the U.K. government for expanding its offerings into precision medicine to diagnose and predict treatment response for eosinophilic esophagitis.

“Building on their achievements in the United Kingdom, Cyted’s FDA clearance marks an exciting milestone for the global business,” Gail Marcus, chair and non-executive director of Cyted, said in the release. “We are excited to continue to empower patients by providing innovative solutions for diagnosing gastrointestinal diseases.”

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Cyted snags FDA 510(k) clearance for non-endoscopic esophageal precancer test

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