ProPhase Labs Seeks to Transform Esophageal Cancer Detection and Management with Launch of its BE-Smart Test in H2 2024
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Insights
The commercialization of the BE-Smart test by ProPhase Labs represents a significant stride in the field of oncology diagnostics. The test's focus on esophageal adenocarcinoma (EAC), a cancer with historically poor prognosis due to late detection, could potentially transform the standard of care in this disease space. From a research perspective, the test's reliance on sophisticated proteomics for early detection is noteworthy. Proteomics, the large-scale study of proteins, is important in understanding disease mechanisms and identifying biomarkers for early diagnosis. The BE-Smart test's ability to stratify patients based on risk may lead to more personalized and potentially cost-saving treatment plans, reducing the burden of unnecessary procedures for low-risk individuals while enabling early interventions for high-risk patients.
From a data analysis standpoint, the collaboration with institutions like the Mayo Clinic and Genesis Clinical is pivotal. These partnerships suggest that the test is undergoing rigorous clinical verification and statistical analysis, which are essential for ensuring the accuracy and reliability of diagnostic tests. The anticipated wide clinical use could be a game-changer, considering the current lack of effective targeted treatments for EAC. The validation studies' success could also encourage further investment in research and development within the oncology diagnostic field, potentially leading to advancements in other cancer diagnostics.
Lastly, the test's potential market size, estimated at $7 billion to $14 billion and the expected reimbursement rates of $1,000 to $2,000 per test indicate a substantial economic impact. For investors, the successful commercialization of BE-Smart could mean a significant return on investment, especially if the test becomes the standard of care for EAC screening and monitoring.
ProPhase Labs' announcement on the BE-Smart test's progress is a strong indicator of the company's potential market impact in the near term. The diagnostic market for EAC is currently underpenetrated, presenting a substantial opportunity for growth. The test's ability to leverage existing endoscopy procedures for sample collection is an excellent example of incremental innovation that utilizes current medical practices to enhance patient outcomes without requiring significant changes to existing medical infrastructure.
Moreover, the pursuit of Advanced Diagnostic Laboratory Test (ADLT) status and the importance of obtaining CPT codes cannot be understated. These codes are critical for ensuring that healthcare providers can bill and receive reimbursement for new tests. The successful acquisition of these codes would facilitate the test's adoption by making it financially viable for healthcare providers to offer it to patients.
Investors should note the strategic partnerships with mProbe Inc. and Genesis Clinical, which could provide ProPhase with a competitive edge in the precision health market. The emphasis on clinical proteomics and the development of advanced algorithms for risk stratification are indicative of a trend towards more personalized healthcare solutions. Such partnerships not only enhance the product's credibility but also expand its potential applications, possibly leading to diversification into other areas of oncology diagnostics.
The financial implications of ProPhase Labs' BE-Smart test for esophageal cancer detection are multi-faceted. The projected reimbursement rates and the large addressable market indicate a robust revenue stream upon successful commercial launch. It is essential to consider the cost-effectiveness of the test compared to the current standard of care, which includes frequent endoscopies. If the BE-Smart test can reduce the frequency of these procedures while maintaining or improving diagnostic accuracy, it could result in significant savings for the healthcare system and, by extension, payers and patients.
The validation studies and subsequent partnerships with renowned institutions could serve as catalysts for investor confidence, potentially leading to an increase in the company's stock price as milestones are reached. However, investors should be mindful of the risks involved in the regulatory approval process and the potential for delays in commercialization. The anticipation of CPT code approval in the second half of 2024 suggests a clear timeline, but regulatory hurdles can be unpredictable.
Additionally, the long-term success of the BE-Smart test will depend on its adoption by the medical community and its integration into existing clinical guidelines. Investors should monitor the outcomes of the validation studies and the response from the medical community post-launch to assess the test's market traction and long-term viability.
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
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.
“Once completed, we anticipate that the analytical validation studies will demonstrate to the scientific and medical community the BE-Smart test’s reliability, accuracy, and readiness for widespread clinical use,” said Igor Ban, PhD, director of Research and Development at ProPhase. “Understanding the critical role of extensive data in improving diagnostic tools, we are reaching out to research hospitals across the US and Europe to form partnerships. These collaborations will provide BE-Smart with access to a wider array of esophageal tissue samples, including those from diverse patient demographics and various stages of Barrett’s Esophagus and EAC. Following commercialization, this invaluable data pool will enable BE-Smart to conduct more nuanced analyses, continuously advancing the test's sensitivity, specificity, and overall utility.”
Within the coming months, the Company anticipates submitting the documentation required for BE-Smart’s Advanced Diagnostic Laboratory Test (ADLT) application, a subclass of the Current Procedural Terminology (“CPT”) Proprietary Laboratory Analyses (“PLA”) coding system. ProPhase plans to commercially launch BE-Smart following CPT code approval, which is anticipated in the second half of 2024, paving the way for a new era in cancer diagnostics.
Obtaining CPT codes is important for billing purposes, enabling ProPhase Labs to bill for providing the test services and receive reimbursement from insurance companies. The Company is diligently preparing and compiling all necessary documentation to ensure compliance with regulatory standards.
Developed over six years, the BE-Smart test leverages sophisticated proteomics to improve early detection of EAC, a valuable tool given that EAC is among the deadliest cancers with no effective currently available targeted treatments. This unfortunate situation, where approximately 80
Through its partnership with Genesis Clinical, the Company is bolstering BE-Smart's capability to stratify esophageal cancer risk accurately, a development of immense value to patients and insurance providers. The test's innovative approach not only promises early detection but also promises to stratify patients into low or high-risk groups with remarkable accuracy.
Mr. Karkus continued, “This risk assessment is crucial, offering peace of mind to those at low risk and potentially sparing them from unnecessary and costly annual endoscopies. For high-risk individuals, it facilitates timely interventions, such as ablation procedures reimbursed by insurance, offering a lifesaving and cost-effective solution compared to the management of advanced disease. Being able to provide targeted patient care strategies, we believe that the BE-Smart test stands at the forefront of transforming patient management in EAC, embodying a holistic approach to enhancing patient outcomes through state-of-the-art early detection and personalized care plans. And the beauty of the test is that it is performed on slivers of tissue specimens that are already being extracted during routine endoscopy procedures.”
About ProPhase Labs
ProPhase Labs, Inc. (Nasdaq: PRPH) (“ProPhase”) is a next-generation biotech, genomics, therapeutics and diagnostics company. Our goal is to create a healthier world with bold action and the power of insight. We’re revolutionizing healthcare with industry-leading Whole Genome Sequencing solutions, while developing potential game changer diagnostics and therapeutics in the fight against cancer. This includes a potentially life-saving cancer test focused on early detection of esophageal cancer and potential breakthrough cancer therapeutics with novel mechanisms of action. Our world-class CLIA labs and cutting-edge diagnostic technology provide wellness solutions for healthcare providers and consumers. We develop, manufacture, and commercialize health and wellness solutions to enable people to live their best lives. We are committed to executional excellence, smart diversification, and a synergistic, omni-channel approach. ProPhase Labs’ valuable subsidiaries, their synergies and significant growth underscore our multi-billion-dollar potential.
Footnotes –
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 plans to grow our subsidiaries and build a multi-billion dollar company, our anticipated timeline for developing and commercializing the BE-Smart test, our estimates regarding the target market for esophageal cancer, and the anticipated reimbursement rates for the Be-Smart test. 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 SEC filings. The Company undertakes no obligation to update forward-looking statements except as required by applicable securities laws. Readers are cautioned that forward-looking statements are not guarantees of future performance and are cautioned not to place undue reliance on any forward-looking statements.
For more information, visit www.ProPhaseLabs.com
ProPhase Media Relations and Institutional Investor Contact:
ProPhase Labs, Inc.
267-880-1111
investorrelations@prophaselabs.com
ProPhase Retail Investor Relations Contact:
Renmark Financial Communications
John Boidman
514-939-3989
Jboidman@renmarkfinancial.com
Source: ProPhase Labs, Inc.
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