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Biomerica Announces CMS Medicare Payment Rate of $300 for Revolutionary inFoods® IBS Test
Globenewswire· 2025-12-23 13:19
Core Insights - Biomerica, Inc. announced that the Centers for Medicare & Medicaid Services (CMS) has set a national Medicare payment rate of $300 for its inFoods® IBS test, effective January 1, 2026, under the Clinical Laboratory Fee Schedule (CLFS) [1][9] - The establishment of a dedicated CPT® Proprietary Laboratory Analyses (PLA) code for inFoods® IBS, effective October 1, 2025, enhances the test's market position and patient access [2] Commercial Milestone - The $300 payment rate from CMS provides a foundation for negotiations with private insurers, as CMS is the largest payer in the U.S. healthcare system, accounting for approximately 21% of total healthcare expenditure [3][9] - The CEO of Biomerica emphasized that the pricing determination is a significant milestone for both the company and patients suffering from IBS, positioning the company for commercial growth in 2026 and beyond [4] Market Need - Irritable bowel syndrome (IBS) affects about 10% to 15% of adults in the U.S., translating to over 30 million potential patients, highlighting a significant unmet medical need [4] - Current treatment options for IBS often provide inconsistent relief and may involve side effects, with no FDA-approved drugs for the IBS-M subtype, which represents about one-third of the IBS market [4] Product Efficacy - The inFoods® IBS test utilizes a personalized diagnostic approach to identify food triggers for IBS symptoms, allowing for targeted dietary recommendations [5] - Clinical trials demonstrated that 59.6% of patients who eliminated identified trigger foods met the FDA-standard target for abdominal pain reduction, compared to 42.2% in the control group [6] - Notable efficacy was observed in difficult-to-treat populations, with 67.1% of IBS-C patients and 66% of IBS-M patients achieving FDA-target pain reduction [7] Strategic Positioning - The combination of clinical evidence, a dedicated PLA code, and a national CLFS price represents a pivotal moment for inFoods® IBS [8] - The company plans to work with Medicare Administrative Contractors to secure coverage for the inFoods® IBS test and leverage the established pricing to negotiate with private insurers [10] Value Proposition - The CMS pricing announcement enhances Biomerica's market opportunity by providing a differentiated offering, a large patient population, a personalized medicine approach, and platform potential for additional gastrointestinal conditions [11]
Viewbix: Quantum X Labs Announces Provisional Patent Filing for Quantum-Enhanced Clinical Trials Technology
Globenewswire· 2025-12-22 13:55
Core Viewpoint - Viewbix Inc. is set to acquire Quantum X Labs, which has developed a groundbreaking quantum computing technology that enhances clinical trial methodologies, potentially transforming the pharmaceutical and drug discovery markets [4][5]. Group 1: Acquisition Details - Viewbix has signed a definitive agreement to acquire up to 100% (and not less than 85%) of Quantum X Labs, which includes its expanding patent portfolio [5]. - The acquisition is expected to close within 90 days from December 15, 2025, pending due diligence and regulatory approvals [5]. Group 2: Technological Advancements - Quantum X Labs has filed a provisional patent for a technology that improves Markov Chain Monte Carlo methods using quantum computing, allowing for more efficient sampling from complex probability distributions [2]. - The new methodology aims to reveal hidden biological structures and dependencies in clinical data, enabling better identification of patient clusters and treatment responses with potentially fewer samples than traditional methods [3]. Group 3: Market Implications - The advancements from Quantum X Labs could convert underpowered clinical trial datasets into robust mechanistic evidence, enhancing the success rates of personalized medicine [4]. - As quantum computing technology matures, it positions Viewbix to capture significant value in the pharmaceutical sector by reducing trial costs and timelines [4].
Prophase Labs (NasdaqCM:PRPH) Earnings Call Presentation
2025-12-19 15:00
Business Verticals & Strategic Initiatives - ProPhase Labs is pursuing near-term cash recovery of over $50 million from COVID-19 receivables through Crown Medical Collections [7, 11, 24, 26, 92] - BE-Smart, an esophageal cancer diagnostic test, targets a $7-14 billion market [8, 34] - Nebula Genomics possesses a 16-petabyte DNA dataset, equivalent to roughly 150 million ancestry SNP-based tests, spanning 130 countries [9, 62] - ProPhase Labs signed a Letter of Intent for a proposed reverse merger with Advanced Biological Laboratories S A (ABL), with ABL potentially becoming the majority owner (~76%) [20, 23] BE-Smart Esophageal Cancer Diagnostic - BE-Smart achieved greater than a 95% technical success rate in a key validation study evaluating its performance with esophageal brush cytology samples [44, 93] - The change in the annual incidence of Esophageal Adenocarcinoma (EAC) was 766 67% higher in 2017 compared to 1973 [32] Nebula Genomics - Nebula Genomics' DNA Complete offers Whole Genome Sequencing (WGS) analyzing virtually 100% of an individual's DNA [63] - DNA Expand expands raw DNA data more than 50 times to over 35 million genetic variants [73] Financial Restructuring - ProPhase Labs sold Pharmaloz Manufacturing for $23 6 million [18] - The company is saving over $6 million per year by shutting down the genomics laboratory [18]
Pacira Biosciences Joins PROBE Consortium to Transform Osteoarthritis Research and Care
Globenewswire· 2025-12-18 13:00
Core Insights - Pacira Biosciences has joined the PROBE Consortium to enhance osteoarthritis research and patient care globally, leveraging data from over 70 million individuals [1][3] - The initiative aims to address significant unmet needs in osteoarthritis treatment, particularly due to a lack of innovation since the introduction of ZILRETTA [2][3] Company Overview - Pacira specializes in innovative, non-opioid pain therapies, with three commercial-stage products: EXPAREL, ZILRETTA, and iovera [4] - ZILRETTA is the first and only extended-release intra-articular therapy approved for osteoarthritis knee pain, providing pain relief for up to 16 weeks [5] PROBE Consortium Objectives - The PROBE initiative includes 38 partners from various sectors, aiming to transform osteoarthritis diagnosis and treatment through improved data analysis and trial designs [3][7] - Key strategies include creating a regulation-compliant database network, utilizing AI for disease progression predictions, and developing novel trial endpoints [7]
Allspring Sees Big Opportunities for Small- and Mid-cap Equities in ’26
Yahoo Finance· 2025-12-11 05:02
Group 1 - The S&P SmallCap 600 and MidCap 400 have underperformed compared to the S&P 500 over the past five years, but opportunities for smaller companies are expected to increase as the market shifts focus [2] - Allspring anticipates a rebalancing in the market, with smaller companies and sector-specific players gaining investor attention as AI technology becomes more prevalent [2][3] - Advisors may need to reconsider their allocations as the S&P 500, while currently strong, may become easier to outperform by small and mid-cap stocks in the next phase of AI development [3] Group 2 - AI and technology will remain central themes in 2026, and managers underweight in tech may face significant challenges [4] - Beyond large tech firms, various sectors are expected to benefit from AI integration into business and daily life [4] - The healthcare sector, despite facing challenges such as rising costs and policy uncertainty, is seeing advancements due to AI, which could lead to improved valuations [6] Group 3 - Allspring identifies industrials and materials as key sectors to watch, particularly for their roles in constructing data centers, highlighting companies like Amrize and Gates Corporation [6] - The healthcare sector is experiencing downward pressure on valuations, but AI advancements in personalized medicine present new investment opportunities [5][6]
Resmed Receives FDA Clearance for Personalized Therapy Comfort Settings, to be Marketed as Smart Comfort, an AI-Enabled, Digital Medical Device That Helps Personalize CPAP Therapy
Globenewswire· 2025-12-08 14:00
Core Insights - Resmed has received FDA clearance for its AI-enabled medical device, Smart Comfort, aimed at improving CPAP therapy adherence for patients with obstructive sleep apnea (OSA) [1][2][4] Group 1: Product Overview - Smart Comfort is the first FDA-cleared device that recommends personalized comfort settings for CPAP therapy, launching in early 2026 in a limited U.S. beta version [2] - The device utilizes machine-learning algorithms based on over 100 million nights of de-identified sleep data to tailor comfort settings for users [3] - Smart Comfort aims to address common therapy issues such as comfort and mask fit, promoting long-term adherence to CPAP therapy [3] Group 2: Clinical and Market Impact - The FDA submission was supported by evidence showing that users whose comfort settings matched Smart Comfort recommendations had higher engagement and sustained therapy adherence compared to those using default settings [4] - OSA affects an estimated 61 million people in the U.S., projected to rise to nearly 77 million by 2050, highlighting a significant market opportunity for Resmed [5] - CPAP therapy is recognized as the gold standard treatment for sleep apnea, significantly reducing health risks associated with untreated OSA [5] Group 3: Benefits for Healthcare Providers - Smart Comfort streamlines user setup and follow-up for healthcare providers, allowing clinicians to focus more on clinical decision-making and patient support [6] - The device helps standardize comfort settings, enhancing user confidence that their therapy is personalized [6] Group 4: Company Vision and Commitment - Smart Comfort is part of Resmed's broader connected, personalized sleep-health ecosystem, which integrates AI and cloud-connected devices to enhance therapy efficacy [7] - Resmed is committed to responsible, data-driven innovation to improve sleep health and empower users [8]
Interpace Biosciences Announces Third Quarter 2025 Financial and Business Results
Globenewswire· 2025-11-12 21:01
Core Insights - Interpace Biosciences reported third quarter 2025 net revenue of $8.8 million, a decrease of 29% from $12.3 million in the same quarter of 2024, but an increase of 22% from $7.3 million on a pro forma basis [5][12] - The company achieved income from continuing operations of $1.0 million, down from $1.8 million in the prior year quarter [3][5] - The third quarter marked the first full quarter as a thyroid-only diagnostics testing company, with record thyroid test volumes and revenue [2][4] Financial Performance - Q3 2025 cash collections totaled $10.0 million, compared to $11.2 million in the prior year quarter [5] - Gross profit percentage was 62%, compared to 64% in the prior year quarter [5] - Adjusted EBITDA for Q3 2025 was $1.3 million, down from $2.5 million in the prior year quarter [5][21] Operational Highlights - Thyroid test volume increased by 12% year-over-year, reaching record levels [4] - The average revenue per test increased by 5% due to reimbursement improvements [2] - The company focused on enhancing operational efficiency through AI and automation [2] Strategic Positioning - Interpace's unique combination testing platform, including ThyGeNEXT and ThyraMIRv2, supports physicians in making informed patient-management decisions [2][7] - The company is positioned as an emerging leader in personalized medicine, offering specialized services along the therapeutic value chain [6]
Oracle and Ci4CC Partner to Accelerate Oncology Innovation
Prnewswire· 2025-11-07 14:45
Core Insights - The collaboration between Oracle Health and Life Sciences and the Cancer Center Informatics Society (Ci4CC) aims to advance AI innovation in oncology care and research [1][2] - The partnership will focus on designing an EHR optimized for cancer care, integrating clinical and genomic data for personalized medicine, and pioneering AI-driven approaches for clinical trial innovation [2][3] Collaboration Details - The strategic collaboration combines Oracle's technology with Ci4CC's national network of NCI-Designated and Community Care Cancer Centers [2] - The initiative will include establishing robust real-world evidence frameworks and advancing precision oncology platforms [2][4] Leadership Statements - Seema Verma from Oracle emphasized the potential of AI and data science in combating cancer, highlighting the opportunity to accelerate discoveries [2] - Sorena Nadaf-Rahrov from Ci4CC noted that advancements in cancer research require collaborative networks, which is central to their mission [3][4] Operational Goals - The collaboration aims to turn data into actionable knowledge to improve cancer research and patient care [4] - The agreement is non-binding, indicating a flexible approach to the partnership [4]
Biomarker Deals Accelerate: Strategic Alliances Reshape Life Sciences Innovation
Globenewswire· 2025-11-05 15:13
Core Insights - The report "Biomarker Deals: Terms Value and Trends 2019-2025" indicates a shift in investment priorities and an increase in biomarker innovation through partnerships to enhance development and market reach [1][2] Market Dynamics - The global biomarkers industry is experiencing a surge in strategic transactions, including licensing, acquisitions, and collaborations, with various deal structures such as upfront payments and milestone-based compensation [2] - The demand for precision medicine, early disease detection, and targeted therapies is driving new biomarker-related partnerships and acquisitions [3] Growth Drivers - The rising incidence of chronic and infectious diseases, such as cancer and diabetes, is increasing the need for early diagnosis and effective treatment, thereby driving demand for biomarkers [4] - Advances in omics and imaging technologies are revolutionizing biomarker discovery and validation, making development more efficient and precise [5] - The shift towards personalized medicine is increasing the need for reliable biomarkers, leading to more partnerships and licensing deals focused on targeted diagnostics and therapies [6] Market Segmentation - The report segments the market based on deal type, including licensing, acquisitions, and collaborations, with partnerships expected to dominate through 2025 [13][14] Challenges and Opportunities - Key challenges in the biomarkers market include high development costs and the need for skilled labor, while opportunities lie in emerging markets and the growth of personalized medicine [15] Emerging Startups - Notable emerging startups in the biomarker space include Grail, Nucleix, Biodesix, and SomaLogic [10][19] Market Leaders - Major players in the biomarkers industry include Abbott, Agilent Technologies, Bayer AG, and Thermo Fisher Scientific, among others [20]
Labcorp Positioned For Gradual Upside With Resilient Margins And Dividend Support
Benzinga· 2025-10-28 18:45
Core Insights - Laboratory Corp reported third-quarter 2025 adjusted earnings per share of $4.18, an increase from $3.50 a year ago, surpassing the consensus of $4.18 [1] - Sales rose 8.6% year-over-year to $3.56 billion, also beating the consensus of $3.56 billion [1] - The sales increase was attributed to organic revenue growth of 6.2%, acquisitions net of divestitures at 1.7%, and foreign currency translation contributing 0.7% [1] Financial Performance - Adjusted operating income for the quarter was $396.6 million, representing 11.1% of revenue [1] - The company revised its fiscal year 2025 adjusted earnings guidance from $16.05-$16.50 to $16.15-$16.50, compared to the consensus of $16.32 [3] - LabCorp lowered its 2025 sales guidance from $14.08 billion-$14.23 billion to $13.97 billion-$14.05 billion, against the consensus of $14.01 billion [3] Growth Projections - LabCorp forecasts 2025 sales growth of 7.4%-8%, down from prior guidance of 7.5%-8.6% [3] - The guidance includes Diagnostics Laboratories sales growth of 7.2%-7.8% and Biopharma Laboratory Services sales growth of 5.7%-7.1% [4] Market Position - Analyst Andrew F. Brackmann from William Blair reiterated an Outperform rating, noting LabCorp's steady organic growth in diagnostics and a solid M&A pipeline [4] - The company is positioned for long-term earnings growth, supported by a steady dividend and resilient valuation multiple [4] Stock Performance - Laboratory Corp's stock is down 5.23% at $261.25 as of the last check on Tuesday [5]