GARDEN CITY, NY - ProPhase Labs, Inc. (NASDAQ: PRPH), a biotech, genomics, and diagnostics company, is nearing the completion of clinical studies for its BE-SMART esophageal cancer diagnostic test, with plans for commercialization in 2024. The test is designed to detect early signs of cancer in individuals with Barrett's esophagus, a known risk factor for esophageal cancer.
The company has recently analyzed an additional 139 specimens in collaboration with The Mayo Clinic to assess the test's precision and reliability. These specimens have shown positive preliminary results and are currently under review by Genesis Biotechnology Group for independent verification.
BE-SMART is a mass spectrometry-based diagnostic test, which ProPhase Labs claims is the only one of its kind for cancer progression surveillance in Barrett’s esophagus patients. It aims to provide both diagnostic and prognostic capabilities, potentially offering a transformative approach in diagnosing and managing esophageal cancer.
The United States Patent and Trademark Office has granted ProPhase Labs a patent for the BE-SMART technology. The test has demonstrated a molecular precision in excess of 99%, according to a study published in Frontiers in Oncology. It also claims to offer versatility and effectiveness over traditional biopsy methods.
As a laboratory-developed test (LDT), BE-SMART is expected to adapt to new potential protein markers. ProPhase anticipates the completion of the analysis by Genesis Biotechnology Group by early Q2 and is preparing for strategic collaborations to secure reimbursement rates for wide-scale adoption.
Ted Karkus, CEO of ProPhase Labs, stated that BE-SMART could become the standard of care for the over 20 million Americans monitored for Barrett's esophagus. The company aims to achieve reimbursement rates of $1,000 - $2,000, although this cannot be assured.
The BE-Smart Esophageal Pre-Cancer Diagnostic Screening test has been tested on over 200 human samples by mProbe, Inc., and has shown promising results in distinguishing histologic classifications. The goal of widespread adoption would allow health care providers to initiate early treatment processes and potentially reduce unnecessary endoscopies.
ProPhase Labs is focused on creating a healthier world through its contributions to the healthcare sector, including Whole Genome Sequencing solutions and the development of diagnostics and therapeutics in the fight against cancer.
This article is based on a press release statement and includes forward-looking statements that involve risks and uncertainties. The information provided should not be seen as an endorsement of ProPhase Labs or its products.
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