ProPhase Labs Announces Significant Progress in BE-Smart Esophageal Cancer Test Development USPTO grants additional broad patents for BE-SMART

Garden City, NY, Feb. 20, 2024 (GLOBE NEWSWIRE) -- ProPhase Labs, Inc. (NASDAQ: PRPH), a next generation biotech, genomics and diagnostics company, today announced important developments in the Company’s efforts to commercialize its novel BE-SMART esophageal cancer diagnostic test.

BE-Smart is a novel diagnostic test that is intended to detect and quantify early signs of certain types of cancer in individuals with Barrett's esophagus, a condition known to significantly increase the risk of developing esophageal cancer. This breakthrough test, in development for nearly five years, is nearing completion of clinical studies. If the clinical trial results are successful, the Company will be aiming for commercial launch during 2024. Recently, an additional 139 specimens were analyzed in collaboration with The Mayo Clinic, for the purposes of assessing the test's precision and reliability in identifying esophageal adenocarcinoma risk. These additional specimens continue to achieve consistently positive preliminary results. All tested samples are currently under review by Genesis Biotechnology Group (“Genesis”), a leading independent statistical analysis firm, for independent verification of the results.

Key Milestones and Innovations:

-BE-Smart is the only mass spectrometry-based diagnostic intended for cancer progression surveillance in Barrett’s esophagus patients. The test is believed to have both high diagnostic (disease type and stages confirmation) and prognostic (molecular analysis of tissue indicative of disease progression or stability) capabilities. Subject to successfully completing the testing phase and regulatory compliance, both aspects of the test will be bundled into one offering for use by gastroenterologists, and GI pathologists and other health care professionals. The ability to identify whether an individual is at high-risk would offer a transformative approach in diagnosing and managing this deadly disease, potentially saving lives and reducing healthcare costs.
- The United States Patent and Trademark Office (USPTO) has granted ProPhase Labs a patent safeguarding the BE-Smart technology and extending protection to similar biomarker discovery processes for various diseases.
- The test has demonstrated molecular precision in excess of 99%¹, which is a remarkably precise accomplishment in cancerous tissue analysis.
- Recent studies on additional samples using a brush technique appear to confirm the test's versatility and effectiveness compared to traditional biopsy methods.