ProPhase Labs Seeks to Transform Esophageal Cancer Detection and Management with Launch of its BE-Smart Test in H2 2024

Garden City, NY, April 10, 2024 (GLOBE NEWSWIRE) -- ProPhase Labs, Inc. (NASDAQ: PRPH) (“ProPhase” or the “Company”), a next-generation biotech, genomics, and diagnostics company, today reported its progress on the commercialization of its breakthrough BE-Smart test for esophageal cancer. The Company is aiming for commercial launch in the second half of 2024.

Ted Karkus, CEO of ProPhase Labs, commented, “The BE-Smart test is more than an advancement in medical technology; it is providing a critical solution to esophageal cancer by enabling early and cost-effective detection. Early detection offers patients the opportunity for more favorable outcomes and a brighter, healthier future. This groundbreaking diagnostic test is a patent-protected method for identifying esophageal cancer markers and a key component of ProPhase Labs’ mission to enhance early detection and facilitate personalized treatment strategies and reflects our commitment to saving lives and improving patient care.”

The BE-Smart test constitutes a major innovation in the detection and management of esophageal adenocarcinoma (“EAC”) and stands at the forefront of a diagnostic revolution. ProPhase intends to pursue and seeks to capture a significant share of a multi-billion-dollar market for EAC diagnostics. The Company anticipates reimbursement rates ranging between $1,000 and $2,000 per test based on CPT codes (as defined below) of similarly complex tests^[1]. By addressing the annual estimated demand for 7 million endoscopies in the U.S. alone for severe GERD and Barrett’s Esophagus cases, the BE-Smart test targets an initial market size of $7 billion to $14 billion.

ProPhase Labs, in collaboration with mProbe Inc., a precision health and medicine company utilizing clinical proteomics in the oncology space, is nearing completion of rigorous validation studies of the BE-Smart test, which at its core aims to accurately implement our patent-protected method for identifying esophageal cancer markers. This phase of analytical validation is being completed in parallel with clinical verification by institutions including the Mayo Clinic and Genesis Clinical, a leader in statistical analysis and algorithm development.