ProPhase Labs Secures Full USPTO Approval for Esophageal Adenocarcinoma Risk Assessment Patent.

ProPhase Labs secured a US patent for its biomarker systems to assess esophageal cancer risk. The BE-Smart diagnostic test achieved a 95% technical success rate, enhancing early detection capabilities. The patent covers key biomarkers and supports new treatment approaches for esophageal diseases. ProPhase CEO Ted Karkus stated that the company is well-positioned to accelerate commercialization and provide wider clinical access to this potentially life-saving technology.

ProPhase Labs, Inc. (Nasdaq: PRPH) has secured a significant milestone with the issuance of U.S. Patent No. 12379378-B2, which protects biomarker-driven systems and methods to assess progression risk in Barrett’s esophagus and esophageal adenocarcinoma [1]. The patent issuance follows the successful validation of the BE-Smart™ molecular diagnostic test, which achieved a 95% technical success rate in detecting key biomarkers [2].

The BE-Smart™ test is designed to work with both forceps and brush biopsies, enhancing early detection capabilities. Brush biopsies capture a broader, more representative epithelial cell population, while forceps biopsies provide targeted tissue sampling. This dual compatibility supports the test's ability to advance early detection and risk stratification in patients with GERD, Barrett’s esophagus, and other distal esophageal disorders [1].

The patented methods involve detecting biomarkers such as ISG15, LTF, CNDP2, DAD1, SET, UBE2N, S100P, and GPI, which are crucial for assessing the risk of Barrett's esophagus pathogenesis and esophageal adenocarcinoma progression. These biomarkers enable novel treatment approaches, including inhibiting cancer cell proliferation and migration and enhancing tumor susceptibility to cytotoxic therapies [1].

The issuance of this patent underscores the strong scientific foundation and clinical relevance of ProPhase Labs’ technology. CEO Ted Karkus stated, "This achievement, coming on the heels of our BE-Smart™ validation demonstrating greater than a 95% technical success rate and dual compatibility with both brush and forceps biopsies, solidifies our leadership in medical innovation and brings us one step closer to transforming early detection and treatment strategies for this serious condition" [1].

ProPhase Labs aims to accelerate commercialization and broaden clinical access to the BE-Smart™ test, which could have a significant impact on the $10 billion target market for esophageal cancer detection [2]. The company's strategic initiatives also include the potential sale of Nebula Genomics and recovering up to $50 million in Covid accounts receivables through the Crown Medical Collections project [2].

References:
[1] https://finance.yahoo.com/news/prophase-labs-announces-full-uspto-120000789.html
[2] https://www.ainvest.com/news/prophase-labs-receives-patent-biomarker-driven-esophageal-cancer-detection-system-2508/