Lucid’s regulatory dreams come true with European approval for esophageal cancer test for people with chronic heartburn

Lucid’s regulatory dreams come true with European approval for esophageal cancer test for people with chronic heartburn

People at a higher risk of contracting esophageal cancer—including those with chronic heartburn and acid reflux—now have a clear pathway to an early diagnosis.

That clarity comes courtesy of PAVmed subsidiary Lucid Diagnostics, which received CE marks for two components of its diagnostic test for Barrett’s esophagus. The precursor condition to esophageal cancer can cause frequent chest pain and heartburn, following long-term damage to the esophagus from acid reflux disease.

The first of the European approvals was awarded at the end of May to its EsoCheck cell collection device: A small swab the size of a drug capsule is attached to a thin tube and swallowed by the patient. Once it reaches the stomach, the ridged swab is inflated and pulled out, gathering samples from the entire length of the esophagus.

The entire process takes about five minutes and does not require a comparatively expensive endoscopy exam, the current method for screening for Barrett’s esophagus. The sample can be run through any commercially available diagnostic test.

The second of Lucid’s CE marks, granted last week, covers its own EsoGuard diagnostic. The test analyzes DNA for 31 biomarkers associated with Barrett’s esophagus.

In a clinical study sponsored by the National Institutes of Health, EsoGuard was proven to detect the condition with 95% sensitivity and 91% specificity when used on cytology brushing samples, and with more than 90% sensitivity and almost 92% specificity when used in tandem with the EsoCheck balloon device.

The company will begin rolling out the two-part system to Europe “in the near future,” Lishan Aklog, Lucid’s executive chairman and CEO of its corporate parent, PAVmed, said in a statement.

“We believe Europe will be an important market for EsoGuard and EsoCheck, where chronic heartburn is as ubiquitous, and esophageal cancer as deadly, as it is in the U.S.,” Aklog said.

Esophageal cancer is the fastest-growing cancer in the U.S., where the disease is estimated to have a five-year survival rate of less than 20%, according to Lucid.

With the two CE marks under its belt, Lucid will now set its sights on obtaining full regulatory approval in the U.S. The EsoCheck device received 510(k) clearance from the FDA in June 2019 and, shortly after, the company launched EsoGuard as a lab-developed test, which typically doesn’t require FDA premarket notification.

After that, Lucid began the process of pursuing an official FDA green light for the EsoGuard diagnostic to be used in widespread screening in the form of either premarket authorization or a de novo approval. It seems to be on the right track: The FDA granted EsoGuard its breakthrough device designation in early 2020, offering it an accelerated regulatory path.

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