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Co-Diagnostics Performs Analysis of Influenza Co-Primers® to Confirm Reactivity Against Flu A H3N2 Mutation
Prnewswire· 2025-12-17 14:00
Core Viewpoint - Co-Diagnostics, Inc. has conducted an in silico analysis of its Logix Smart ABC test, confirming its effectiveness against the influenza A H3N2 subclade K, which is significant due to the current flu season and vaccine mismatch [1][2][3]. Group 1: Company Developments - The Logix Smart ABC test has shown high homology against 3,900 influenza sequences, indicating comparable reactivity against the H3N2 subclade K [1]. - The test received CE-marking in November 2020 for the simultaneous detection of influenza A, influenza B, and SARS-CoV-2, with no concerns regarding sensitivity from emerging H3N2 strains [3]. - In November 2025, the company initiated clinical performance testing for a new PCR Flu A/B, COVID-19, RSV point-of-care multiplex test, aimed at FDA 510(k) clearance [4]. Group 2: Industry Context - The World Health Organization reports that seasonal influenza leads to approximately 3–5 million severe illness cases and 290,000–650,000 respiratory fatalities annually [2]. - The current flu vaccine is mismatched with the H3N2 subclade K, which has limited natural immunity in communities, raising concerns about higher hospitalization and death rates [2]. - Preliminary data indicates that countries like Japan and the UK are experiencing earlier flu seasons in 2025, following a record flu season in Australia [2].
Volition Issues Business Review 2025
Prnewswire· 2025-12-17 13:45
Core Insights - VolitionRx Limited has made significant progress in 2025, focusing on the commercialization of its Nu.Q® platform for human diagnostics, with key milestones achieved in cancer and sepsis detection [2][3][4] Group 1: Business Developments - The company received its first order for Nu.Q® Cancer assays for clinical certification in lung cancer and included the Nu.Q® NETs assay in a government-backed program in France for early sepsis detection, valued at approximately $7.3 million [3][4] - Volition signed two licensing agreements with major companies, Werfen and Hologic, marking a strategic move into the human diagnostics market [5] - The company is in discussions with around 10 leading diagnostic and liquid biopsy companies to secure additional licensing agreements, anticipating announcements throughout 2026 [6][7] Group 2: Financial Opportunities - The Total Addressable Markets (TAMs) for Volition's technologies are substantial, including $2.3 billion for lung cancer screening, $23 billion for multi-cancer early detection, and $2.8 billion for sepsis early detection [11] - The company aims to replicate its successful licensing strategy in the veterinary market within the human diagnostics space, with potential for diverse deal structures and recurring revenue [7][10] Group 3: Scientific and Clinical Progress - Volition's Nu.Q® NETs assay is being evaluated in over 20 hospitals across 10 countries for various clinical use cases, indicating its potential to become a routine blood test [8] - The company has achieved significant scientific advancements, including the development of a lateral flow test for quantifying nucleosomes, which aids in clinical decision-making [10] - A large-scale study demonstrated that the Nu.Q® NETs H3.1 biomarker is an independent predictor of mortality in sepsis patients, showcasing the assay's clinical relevance [10]
Landmark Study Shows Combination of Castle Biosciences' DecisionDx®-UM and PRAME Outperforms Gene Mutation Analysis in Predicting Survival Outcomes in Uveal Melanoma
Globenewswire· 2025-12-17 12:00
Core Insights - Castle Biosciences, Inc. announced new data from the largest prospective, multicenter study comparing next-generation sequencing (NGS)-based gene mutation analysis with the combination of DecisionDx-UM and PRAME gene expression for predicting outcomes in uveal melanoma (UM) patients [1][2] Study Findings - The study validated that the combination of DecisionDx-UM and PRAME provides more precise metastatic risk prediction for UM patients than either test used independently [2] - The combination of DecisionDx-UM and PRAME delivers superior predictions of metastasis-free survival (MFS) and overall survival (OS) compared to NGS-based mutation analysis [2] - The study analyzed 1,140 primary UM tumors, including 131 small, early-stage tumors, using NGS to assess seven clusters of recurrent genetic mutations [2] Test Offerings - Castle currently offers three tests for UM: DecisionDx-UM, DecisionDx-PRAME, and DecisionDx-UMSeq, all from a single biopsy sample [3] - These tests provide comprehensive molecular insights for precise risk assessment and informed treatment planning for UM patients [3] Collaborative Ocular Oncology Group (COOG) - COOG is the largest collaborative working group in North America focused on intraocular cancers, particularly uveal melanoma, comprising over 25 leading academic and private ocular oncology centers [4] - COOG has conducted two large multicenter prospective studies of prognostic biomarkers in uveal melanoma, the first of their kind in this cancer [4] DecisionDx-UM Overview - DecisionDx-UM is a gene expression profile test that predicts personalized risk of metastasis from uveal melanoma by stratifying patients into low-, intermediate-, or high-risk groups [5] - The test has been widely adopted as the standard of care in the U.S. and is included in the AJCC Staging Manual and NCCN Guidelines, with nearly 80% of newly diagnosed patients undergoing testing [6]
Cofactor Genomics Announces Strategic Investment by Labcorp and Ascension Ventures to Fuel Expansion of Its OncoPrism® Immunotherapy Diagnostic Across U.S. Cancer Care Networks
Businesswire· 2025-12-15 15:00
Core Insights - Cofactor Genomics has received strategic investments from Labcorp and Ascension Ventures to enhance its operations and expand its market presence [1] Company Summary - Cofactor Genomics is a commercial-stage diagnostics company focused on transforming precision oncology through RNA-based predictive tests [1] - The new financing aims to accelerate Cofactor's nationwide expansion and increase patient access to its immunotherapy-response diagnostics [1] Industry Context - Ascension Ventures is the strategic investment arm of 13 leading U.S. health systems across 22 states, representing over $100 billion in assets [1]
Trinity Biotech Expands Global Rollout of High-Capacity Column System for FDA-Cleared HbA1c Testing Solution After Securing Regulatory Clearances
Globenewswire· 2025-12-15 14:15
Core Insights - Trinity Biotech is advancing its mission to deliver next-generation diabetes management solutions and expand its global market penetration, particularly in the $2 billion+ HbA1c market [1][2] Company Developments - Trinity Biotech has secured regulatory clearances in multiple countries for its next-generation high-capacity HbA1c column system for the Premier Hb9210 analyzer, which is now available in over 10 countries, including the United States [1] - The upgraded column system enhances testing throughput by up to four times compared to the existing system, reduces instrument downtime, and minimizes maintenance requirements, leading to improved operational efficiency [3][7] - The Premier Hb9210 solution is recognized as a gold standard in HbA1c testing, with strong clinical performance confirmed by peer-reviewed studies [3] Market Potential - The global laboratory HbA1c market is currently valued at over $2 billion and is projected to exceed $3.5 billion by 2030, driven by the increasing prevalence of diabetes [2] - The launch of the advanced system in key markets positions Trinity Biotech to capture further growth opportunities in the global diabetes care segment [3] Operational Efficiency - The new column system's operational gains create a more efficient workflow for clinical laboratories, supporting broader adoption of the platform [3] - The latest software update enhances automation of routine tasks, enabling greater productivity and cost savings [7]
20/20 GeneSystems(AIDX) - Prospectus
2025-12-12 22:19
As filed with the U.S. Securities and Exchange Commission on December 12, 2025 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 20/20 BIOLABS, INC. (Exact name of registrant as specified in its charter) Delaware 8734 57-2272107 (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) 15810 Gaither ...
Abbott increases quarterly dividend for 54th consecutive year
Prnewswire· 2025-12-12 15:26
Core Viewpoint - Abbott has announced a 6.8% increase in its quarterly common dividend to 63 cents per share, marking its 54th consecutive year of dividend growth and the 408th consecutive quarterly dividend payment since 1924 [1][4]. Group 1: Dividend Information - The quarterly dividend payout has increased more than 70% since 2020 [1][4]. - The cash dividend is payable on February 13, 2026, to shareholders of record as of January 15, 2026 [1]. Group 2: Company Background - Abbott is a global healthcare leader with a diverse portfolio in diagnostics, medical devices, nutritionals, and branded generic medicines, serving over 160 countries [3]. - Abbott is a member of the S&P 500 Dividend Aristocrats Index, which includes companies that have increased dividends annually for at least 25 consecutive years [2].
What Is Driving Hologic's Strength in the US Diagnostics Market?
ZACKS· 2025-12-12 13:36
Core Insights - Hologic (HOLX) is positioned to capture market share in the diagnostics sector, despite recent macroeconomic challenges affecting its performance [1] - The U.S. diagnostics market is projected to grow at a CAGR of 9.12% from 2025 to 2030, indicating strong future potential for Hologic [1] Diagnostics Segment Performance - In Q4 of fiscal 2025, Diagnostics revenues increased by 1.5% in constant currency, driven by higher core U.S. molecular diagnostics sales [2] - Organic diagnostics sales, excluding COVID-19 revenues, grew by 4.4% in constant currency [2] - The Molecular Diagnostics unit is the main growth driver, with significant contributions from BV, CV/TV, and Panther Fusion assays [2] Product Developments and Innovations - The Panther Fusion system is highlighted for its efficiency and ability to consolidate testing, utilizing PCR technology for over 23 assays [3] - Recent approvals for the Genius Digital Diagnostics System and Panther Fusion assays are expected to enhance Hologic's market position [4] Competitive Landscape - Abbott (ABT) has expanded its continuous glucose monitor to Android devices, increasing accessibility for users [5] - Roche Holdings (RHHBY) has received CE Mark approval for its mass spectrometry reagent pack and cobas BV/CV assay, broadening its IVD offerings [6] Stock Performance and Valuation - Hologic shares have increased by 3.8% year-to-date, outperforming the industry growth of 3.1% [7] - The company is trading at a forward five-year price-to-sales (P/S) ratio of 3.86X, which is lower than the industry average of 4.35X [9]
Systematic Review and Meta-Analysis Confirms TissueCypher® Outperforms Traditional Pathology or Clinical Factors Alone to Identify Patients at Increased Risk of Developing Esophageal Cancer
Globenewswire· 2025-12-12 12:00
Core Insights - Castle Biosciences, Inc. announced a systematic review and meta-analysis demonstrating that the TissueCypher® Barrett's Esophagus test provides clinically validated risk stratification for patients with Barrett's esophagus, outperforming traditional pathology or clinical factors in identifying patients at increased risk of developing esophageal cancer [1][2]. Group 1: Study Findings - The systematic review and meta-analysis consolidated data from six studies, confirming that TissueCypher consistently identifies patients at greater risk of progression to high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC) [2]. - The study represents the most comprehensive validation of the TissueCypher test to date, reinforcing its value as an evidence-based tool for risk stratification in Barrett's esophagus [3][5]. - TissueCypher has been shown to be the strongest independent predictor of progression compared to traditional histopathological risk assessment, with high-risk results indicating patients are 6.7 times more likely to progress to HGD or EAC within five years than those with low-risk results [7][9]. Group 2: Clinical Implications - The findings support personalized, risk-aligned patient management aimed at preventing cancer, allowing physicians to identify which patients may benefit from earlier intervention and those who can continue routine surveillance [3][5]. - Patients with high or intermediate-risk results had an annual progression rate of 2.8%, while those with high-risk results had a rate of 5.6% per year, both exceeding the typical 1.7% annual progression rate for patients with low-grade dysplasia [9]. Group 3: Test Overview - TissueCypher is a precision medicine test designed to predict a patient's personalized risk of progression from Barrett's esophagus to high-grade dysplasia or esophageal adenocarcinoma, indicated for patients with non-dysplastic BE, indefinite for dysplasia, or low-grade dysplasia [6]. - The test utilizes an AI-driven spatialomics approach to identify molecular signatures that precede dysplasia development, enabling earlier identification and management of patients at increased risk of cancer [7].
Microbix Schedules Release of Results for Q4 Fiscal 2025
Globenewswire· 2025-12-11 22:00
Core Insights - Microbix Biosystems Inc. is set to release its Q4 2025 financial results on December 18, 2025, prior to market opening, followed by a webinar discussion with key executives [1] Company Overview - Microbix Biosystems Inc. specializes in proprietary biological products for human health, employing over 120 skilled workers and reporting revenues of C$ 25.4 million in the last fiscal year (2024) [3] - The company supports the global diagnostics industry by providing critical ingredients and devices, including antigens for immunoassays and laboratory quality assessment products (QAPs™) [3] - Microbix's products are utilized by approximately 100 diagnostics manufacturers, and its QAPs are available in over 30 countries through a network of international distributors [3] - The company is accredited with ISO 9001 & 13485, registered with the U.S. FDA, Australian TGA, and licensed by Health Canada, ensuring compliance with IVDR and CE marking [3] Product Development - Microbix also develops proprietary products such as Kinlytic® urokinase, a thrombolytic drug for treating blood clots, and reagents for molecular diagnostic testing [4]