- ProPhase Labs' BE-Smart™ test achieves over 95% success in esophageal cancer detection.
- Launch expected in 2-3 quarters, targeting a $10 billion market with expanded coverage for 73 million U.S. lives.
- Test compatible with both forceps and brush biopsies, addressing diagnostic gaps in traditional methods.
ProPhase Labs Inc. (PRPH, Financial), a leader in biotech and genomics, announced a key milestone with their BE-Smart™ molecular diagnostic test, which has demonstrated a technical success rate exceeding 95% in detecting esophageal cancer biomarkers. This success comes from a validation study utilizing esophageal brush cytology samples, marking a significant advancement in early cancer detection.
The BE-Smart™ test, notable for its dual compatibility with forceps and brush biopsies, addresses the clinical challenges posed by traditional diagnostic methods, which can miss significant areas of Barrett's esophagus. Brush biopsies, known for lower costs and fewer complications, are increasingly favored in clinical practice, making the BE-Smart™ test a timely innovation.
ProPhase plans to launch the BE-Smart™ test clinically within the next 2-3 quarters as a laboratory-developed test (LDT), which often involves a streamlined regulatory pathway compared to FDA-approved diagnostics. This strategic move could potentially position the company advantageously in the $10 billion market for esophageal disease diagnostics.
With expanded payer coverage reaching over 73 million U.S. lives, the BE-Smart™ test is poised to become a major player in esophageal disease surveillance and management. This is particularly crucial given the rising incidence of esophageal adenocarcinoma, a deadly cancer with a 79% mortality rate and significant growth since the 1970s.
