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
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
- 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.
-As a laboratory-developed test (“LDT”), BE-Smart will continue to develop and adapt to new potential protein markers that may arise after the completion of the RNA-Seq data analysis currently being conducted at the
Future Directions and Impact:
As an LDT, BE-Smart's flexibility allows for the incorporation of emerging protein markers, enhancing its diagnostic power. ProPhase anticipates the completion of
“A recent
About the BE-Smart Test
The BE-Smart Esophageal Pre-Cancer Diagnostic Screening test is aimed at early detection of esophageal cancer. It has already been tested by an independent test lab, mProbe, Inc. on over 200 human samples and has shown an area under curve of greater than 99%1 in distinguishing highly impactful histologic classifications.
About
References
1 - Abdo, J., Wichman, C. S., Dietz, N. E., Ciborowski, P., Fleegel, J., Mittal, S. K., & Agrawal, D. K. (2018). Discovery of Novel and Clinically Relevant Markers in Formalin-Fixed Paraffin-Embedded Esophageal Cancer Specimen. Frontiers in Oncology, 8. https://doi.org/10.3389/fonc.2018.00157
Forward Looking Statements
Except for the historical information contained herein, this document contains forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding our strategy, plans, objectives and initiatives, including our anticipated timeline for developing and commercializing the BE-Smart Esophageal Cancer Test and our estimates regarding the target market for esophageal cancer. Management believes that these forward-looking statements are reasonable as and when made. However, such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially from those projected in the forward-looking statements. These risks and uncertainties include but are not limited to our ability to obtain and maintain necessary regulatory approvals, general economic conditions, consumer demand for our products and services, challenges relating to entering into and growing new business lines, the competitive environment, and the risk factors listed from time to time in our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and any other
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investorrelations@prophaselabs.com
ProPhase Retail Investor Relations Contact:
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Jboidman@renmarkfinancial.com
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