FDA News

FDA clears EsoCheck device

The FDA has given 510(k) clearance to the EsoCheck Cell Collection Device, a non-invasive device that assists in the collection of cells to test for Barrett's esophagus, according to a press release from the manufacturer, Lucid Diagnostics.

Amitabh Chak, MD, of Case Western Reserve University School of Medicine, said the device allows for the collection of cells from the esophagus using a small inflatable encapsulated balloon attached to a small catheter. The device protects the sampled cells inside the capsule as it is withdrawn, helping to avoid contamination.

“Barrett’s [esophagus] and esophageal cancer develops in the lower end of the esophagus. So, that’s the area we want to target, and the device gets a little swab of the lower esophagus,” he told Healio Gastroenterology and Liver Disease. “Then, that sample is inverted back into the protected capsule, so we get a very select sample of the targeted ... lower esophagus.”
Chak said the sample is sent away for DNA testing to identify Barrett’s esophagus or esophageal cancer.

Chak said the EsoCheck has advantages over the currently available, sponge-like sampling devices in both time and accuracy.

“The sponge on a string takes a lot longer because you have to wait for the capsule to dissolve,” he said. “It’s a bigger capsule, and the whole sponge inside the capsule is much bigger. The sponge samples the entire esophagus and what’s in the mouth. There’s more potential for contamination.”

Disclosures: Chak reports consulting for Lucid Diagnostics.

The FDA has given 510(k) clearance to the EsoCheck Cell Collection Device, a non-invasive device that assists in the collection of cells to test for Barrett's esophagus, according to a press release from the manufacturer, Lucid Diagnostics.

Amitabh Chak, MD, of Case Western Reserve University School of Medicine, said the device allows for the collection of cells from the esophagus using a small inflatable encapsulated balloon attached to a small catheter. The device protects the sampled cells inside the capsule as it is withdrawn, helping to avoid contamination.

“Barrett’s [esophagus] and esophageal cancer develops in the lower end of the esophagus. So, that’s the area we want to target, and the device gets a little swab of the lower esophagus,” he told Healio Gastroenterology and Liver Disease. “Then, that sample is inverted back into the protected capsule, so we get a very select sample of the targeted ... lower esophagus.”
Chak said the sample is sent away for DNA testing to identify Barrett’s esophagus or esophageal cancer.

Chak said the EsoCheck has advantages over the currently available, sponge-like sampling devices in both time and accuracy.

“The sponge on a string takes a lot longer because you have to wait for the capsule to dissolve,” he said. “It’s a bigger capsule, and the whole sponge inside the capsule is much bigger. The sponge samples the entire esophagus and what’s in the mouth. There’s more potential for contamination.”

Disclosures: Chak reports consulting for Lucid Diagnostics.