FDA awards esophageal DNA test breakthrough device designation

The FDA awarded Pavmed's EsoGuard Esophageal DNA Test breakthrough device designation to aid in diagnosing Barrett's esophagus.

Pavmed created the test to fill the market inefficiency around Barrett's esophagus. Patients with esophageal cancer are often unaware of underlying BE and because of this 80 percent of patients with EAC die within five years of diagnosis.

Pavmed believes the EsoGuard test can capture $2 billion of the U.S. domestic market if it has "very modest penetration."

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