Core Viewpoint - 20/20 BioLabs, Inc. has launched its Class A ordinary shares on the Nasdaq Capital Market under the ticker symbol "AIDX," aiming to scale growth through AI-powered blood tests for cancer and chronic disease detection [1][6]. Financing and Growth Strategy - The company has entered a contingent financing agreement that could provide up to $40 million, with the first $5 million expected to close today [2]. - The CEO emphasized that the Nasdaq listing is a significant milestone that positions the company for substantial growth through both organic means and mergers and acquisitions [6][7]. Product Offerings - 20/20 BioLabs offers OneTest™ for Cancer, an AI-powered multi-cancer early detection blood test that analyzes tumor-associated protein biomarkers, allowing for earlier detection of multiple cancers at a lower price point than competing tests [4][11]. - The upcoming OneTest for Longevity™, expected to launch by the end of February, will track inflammatory biomarkers associated with chronic diseases, enabling consumers to make lifestyle changes to reduce disease risk [5][11]. Technological Innovation - The company's diagnostics leverage AI models built with real-world data, enhancing accuracy and clinical usefulness, and allowing for convenient home access through new blood collection devices [3][11]. - The OneTest for Cancer may be the first multi-cancer early detection test that can be self-collected at home, which is a significant advancement in the field [4]. Regulatory Environment - Recent legislation passed by Congress aims to facilitate Medicare reimbursement for multi-cancer early detection tests by 2028, which could positively impact the company's market potential [4]. Investor Relations - 20/20 BioLabs has launched an Investor Relations section on its website, providing various resources for investors, including press releases, current share prices, and SEC filings [8].

Core Insights - Biomerica, Inc. has received approval from Vietnam's Hanoi Department of Health for its EZ Detect™ colorectal disease at-home screening test, marking a significant step in the company's global expansion into Southeast Asia [1][2][11] Group 1: Product Overview - EZ Detect™ is an FDA-cleared two-minute at-home screening test designed to detect early warning signs of colorectal cancer and other colorectal diseases [2][7] - The test identifies occult blood in stool, which is a critical early indicator of colorectal diseases, including cancer [8] - The test is user-friendly, requiring no special preparation or handling of stool, and can be completed privately at home [8][9] Group 2: Market Opportunity - Colorectal cancer is a significant public health issue in Vietnam, with 16,835 new cases reported in 2022, making it the fourth most common cancer in the country [3] - The five-year survival rate for colorectal cancer in Vietnam is only 45%, compared to 91% in the United States when detected early [3][10] - The global market for colorectal cancer screening is substantial, with approximately 1.93 million new cases and over 900,000 deaths worldwide in 2022, and these figures are expected to rise significantly by 2050 [5] Group 3: Strategic Importance - The approval of EZ Detect™ represents a milestone for Biomerica's strategic entry into Southeast Asia's rapidly growing healthcare market, which has over 680 million people and increasing healthcare spending [2][11] - The company aims to work with a major healthcare distributor in Vietnam to ensure widespread availability of the product through various sales channels [1][11] - This approval serves as a template for potential expansion into other Southeast Asian markets, emphasizing the importance of accessible at-home screening tests [11]

Core Insights - Bluejay Diagnostics has successfully enrolled 545 patients in its SYMON™ II multicenter clinical study, exceeding initial expectations with a target of 750 patients [1][2] - The company is making significant progress in manufacturing readiness and technology transfer initiatives, marking a key transition from clinical enrollment to data analysis and commercialization [1][5] Clinical Study Progress - The SYMON™ II study focuses on IL-6 monitoring, with all patient enrollments conducted under approved IRB protocols [2] - The scale and diversity of the dataset are expected to enhance the company's regulatory positioning and facilitate discussions with future partners and stakeholders [3] Manufacturing Readiness - Manufacturing readiness activities are advancing across multiple workstreams, including antibodies, tooling, analytical validation, and commercial manufacturing infrastructure [4] - Key developments include the completion of monoclonal and polyclonal antibody production, which provides supply capacity for over 10 million test cartridges [8] - Technology transfer activities are progressing effectively, supported by strategies to mitigate timing and scale-up risks [4] Future Outlook - As Bluejay enters 2026, the company believes it is in a stronger execution position with reduced clinical risk and a heightened focus on value realization through data analysis and regulatory engagement [5]

Core Insights - CareDx (CDNA) announced clinical validation data for AlloHeme, a blood-based monitoring test aimed at predicting relapses in acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) post-allogeneic hematopoietic cell transplant (HCT) [1][4] Group 1: AlloHeme Test Details - AlloHeme utilizes next-generation sequencing and artificial intelligence to enhance sensitivity in detecting early relapse signals compared to traditional methods [2][4] - The ACROBAT clinical study demonstrated that AlloHeme achieved 85% sensitivity and 92% specificity, detecting relapses a median of 41 days earlier than standard clinical diagnosis [9][12] - The assay's performance metrics indicate a 95% negative predictive value and a 79% positive predictive value, with an area under the curve of 0.89 [11] Group 2: Commercialization and Market Strategy - CareDx plans to roll out AlloHeme in the U.S. starting with CLIA readiness in 2026, followed by commercialization in 2027 and expected payer coverage by 2028 [3][9] - The company aims to expand its Transplant+ strategy into cell therapy and hematologic oncology, addressing unmet needs in AML and MDS monitoring [3][6] - The integrated offering will combine diagnostics, digital tools, and patient support solutions tailored for the cell therapy ecosystem [4][7] Group 3: Market Performance and Growth Potential - Following the announcement, CDNA shares increased by 2.8%, with a 65.6% rise over the past six months, significantly outperforming the industry and S&P 500 [5] - The clinical validation of AlloHeme is seen as a significant growth catalyst, enhancing CareDx's position in the cell therapy and hematologic oncology markets [6][7] - The cell therapy market is projected to reach $9.13 billion by 2026, with a compound annual growth rate (CAGR) of 22.9% through 2034, driven by advancements in technology and increasing disease prevalence [14][15]

Core Insights - Exact Sciences Corp. reported revenue of $878 million for Q4 2025 and $3.25 billion for the full year 2025, both ending December 31, 2025 [1] Group 1: Financial Performance - The company achieved a revenue of $878 million in the fourth quarter of 2025 [1] - For the full year 2025, Exact Sciences generated a total revenue of $3.25 billion [1] Group 2: Operational Highlights - In 2025, Exact Sciences screened more individuals than ever before, contributing to personalized treatment decisions [1] - The company successfully launched three new tests during the year [1]

Core Insights - QuidelOrtho Corporation (QDEL) reported adjusted earnings per share (EPS) of 46 cents for Q4 2025, a decrease from 63 cents year-over-year, but exceeded the Zacks Consensus Estimate by 6.9% [1] - The company registered revenues of $723.6 million in Q4 2025, reflecting a 2.2% year-over-year increase and surpassing the Zacks Consensus Estimate by 3.6% [2] Financial Performance - The GAAP loss per share for Q4 was $1.92, an improvement from a loss of $2.65 in the same quarter last year [1] - Adjusted gross profit declined 1.8% year-over-year to $325.2 million, with an adjusted gross margin contracting by 190 basis points to 44.9% [9] - Adjusted operating profit totaled $89.3 million, down 8.7% from the prior-year quarter, with an adjusted operating margin of 12.3%, a contraction of 150 basis points [10] Revenue Breakdown - Respiratory revenues were $123.3 million, down 13.9% year-over-year, while Non-Respiratory revenues increased to $600.3 million, up 6.3% [2] - Labs revenues reached $389.2 million, an 8.1% increase, while Immunohematology revenues were $141 million, up 3.4% [3][4] - Donor Screening revenues fell significantly to $11.8 million, down 40.1%, and Point of Care revenues declined to $173.1 million, down 6.4% [4] Geographical Performance - North America revenues were $390.1 million, reflecting a decline of 2.4%, while EMEA revenues increased by 9.3% to $92.7 million [6] - Revenues from China amounted to $91.7 million, up 5.5%, and Latin America revenues increased by 22% to $73.2 million [8] Future Guidance - For 2026, QuidelOrtho expects total revenues to be in the range of $2.7 billion to $2.9 billion, with a consensus estimate of $2.71 billion [12] - The company anticipates steady growth in its core Labs business and low-single-digit growth in Immunohematology, while Point-of-Care revenues are expected to remain flat [13][14]

Financial Data and Key Metrics Changes - Fourth quarter revenue was $724 million, representing a 2% year-over-year increase, with a 7% growth in non-respiratory revenue excluding donor screening [7][18] - Full year revenue reached $2.73 billion, achieving the company's financial guidance for 2025, with non-respiratory revenue growing 5% [7][18] - Adjusted EBITDA margin was 22%, reflecting a 240 basis point improvement over the prior year [8][22] - Adjusted diluted EPS was $0.46 in Q4 and $2.12 for the full year, indicating a 15% year-over-year growth [22] Business Line Data and Key Metrics Changes - Labs business reported a strong growth of 7% in Q4 and 6% for the full year, accounting for 55% of total company revenue [7][18] - Immunohematology business grew 3% for the full year, maintaining its leading global market position [18] - Triage business saw a revenue increase of 16% in Q4 and 7% for the full year [18] - Respiratory revenue declined 14% in Q4 and 20% for the full year due to lower COVID testing [18] Market Data and Key Metrics Changes - North America region revenue was up 4% in Q4 but down 2% for the year, excluding donor screening [20] - Europe, Middle East, and Africa showed flat growth for the quarter and 4% growth for the year, with a significant increase in Adjusted EBITDA margins by over 900 basis points [20] - Latin America experienced a 17% increase in Q4 and 18% for the year, while Japan and Asia-Pacific grew 4% in Q4 and 6% for the year [20] - China grew 5% in Q4 and 3% for the full year [21] Company Strategy and Development Direction - The company established three priorities: customer-centric operations, strengthening operational and financial performance, and accelerating product development for long-term growth [6] - The focus is on optimizing the customer experience and driving effective execution across all business dimensions [9] - The company aims to maximize value by delivering superior outcomes for customers and converting that value into attractive returns for shareholders [8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to sustain growth, citing strong market positions and high renewal rates [35] - The company anticipates continued growth in the Labs business and is optimistic about new product launches in 2026 [14][25] - Management acknowledged challenges in cash flow conversion but emphasized ongoing efforts to improve cash flow metrics [31][88] Other Important Information - A significant non-cash goodwill impairment charge of $701 million was recorded in Q3, which does not impact cash or operations [8][22] - Joe Busky, CFO, announced his retirement effective June 2026, with a search for his successor already initiated [9][10] Q&A Session Summary Question: Free cash flow guidance and timing issues - Joe Busky explained that Q4 cash flow was lower than expected due to timing issues with accounts receivable and late revenue collection [30][31] Question: Sustainability of lab growth trends - Brian Blaser highlighted strong underlying growth rates across the business and emphasized opportunities in immunoassay and low market penetration [33][35] Question: China market updates - Management provided updates on potential nationalized value-based procurement programs but noted no new developments [40][41] Question: Gross margin performance - Joe Busky discussed factors affecting gross margins, including tariffs and product mix, and projected flat margins for 2026 [67][68] Question: Lex Diagnostics platform timeline - Jonathan Siegrist confirmed that the FDA review process for the Lex platform is progressing as planned, with no current issues [72] Question: R&D pipeline and product launches - Management indicated a focus on expanding the product portfolio and enhancing offerings in both domestic and international markets [76][78]

Financial Data and Key Metrics Changes - Fourth quarter revenue was $724 million, representing a 2% year-over-year increase from $708 million, with a 7% growth in non-respiratory revenue excluding donor screening [7][18] - Full year revenue reached $2.73 billion, achieving the 2025 financial guidance, with non-respiratory revenue growing 5% [7][18] - Adjusted EBITDA margin was 22%, a 240 basis point improvement over the prior year [8][22] - Adjusted diluted EPS was $0.46 for Q4 and $2.12 for the full year, reflecting a 15% year-over-year growth [22] Business Line Data and Key Metrics Changes - Labs business reported a 7% growth in Q4 and 6% for the full year, representing 55% of total company revenue [7][18] - Immunohematology grew 3% for the full year, maintaining its leading global market position [18] - Triage business revenue increased by 16% in Q4 and 7% for the full year [18] - Respiratory revenue declined by 14% in Q4 and 20% for the full year due to lower COVID testing [18] Market Data and Key Metrics Changes - North America region revenue was up 4% in Q4 but down 2% for the year, excluding donor screening [20] - Europe, Middle East, and Africa (EMEA) growth was flat in Q4 and up 4% for the year, with adjusted EBITDA margins increasing by over 900 basis points [20] - Latin America saw a 17% increase in Q4 and 18% for the year, while Japan and Asia-Pacific grew 4% in Q4 and 6% for the year [20] - China grew 5% in Q4 and 3% for the full year [21] Company Strategy and Development Direction - The company established three priorities: customer-centric operations, strengthening operational and financial performance, and accelerating product development for long-term growth [6][9] - The focus is on optimizing the customer experience and driving effective execution across all business dimensions [9] - The company aims to maximize value by delivering superior outcomes for customers and converting that value into attractive returns for shareholders [8][9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to sustain growth, citing strong market positions and high renewal rates [35] - The company anticipates continued growth in the Labs business and is optimistic about new product launches in 2026 [14][25] - Management acknowledged challenges in cash flow conversion but emphasized ongoing efforts to improve cash flow metrics [31][89] Other Important Information - A significant non-cash goodwill impairment charge of $701 million was recorded in Q3, which does not impact cash or operations [22] - The CFO announced plans to retire in June, with a search for a successor already initiated [9][10] Q&A Session Summary Question: Free cash flow guidance and timing issues - The CFO explained that Q4 cash flow was lower than expected due to timing issues with accounts receivable and late revenue collection [30][31] Question: Sustainability of Labs business growth - Management highlighted strong underlying growth rates and opportunities in immunoassay and underpenetrated markets as key factors for sustaining growth [35] Question: Updates on China market and VBP program - Management stated that there are no new updates on the nationalized VBP program for dry chemistry test strips, with potential impacts estimated at 0.5% to 1% of total revenue [40][41] Question: Gross margin outlook - The CFO discussed factors affecting gross margins, including tariffs and product mix, and projected flat gross margins for 2026 with potential improvements in the following years [68][70] Question: LEX Diagnostics platform timeline - Management indicated that the FDA review process for the LEX platform is progressing as planned, with no current issues [73] Question: R&D pipeline and U.S. market focus - Management confirmed that while OUS markets are a priority, there are plans to enhance the U.S. product offerings through new menu additions [77][79]

Financial Data and Key Metrics Changes - Fourth quarter revenue was $724 million, a 2% increase from $708 million in the prior year, with a 7% growth in non-respiratory revenue excluding donor screening [6][18] - Full year revenue reached $2.73 billion, achieving the 2025 financial guidance, with non-respiratory revenue growing 5% [6][18] - Adjusted EBITDA margin was 22%, reflecting a 240 basis point improvement year-over-year [8][21] - Adjusted diluted EPS was $0.46 for Q4 and $2.12 for the full year, representing a 15% year-over-year growth [21] Business Line Data and Key Metrics Changes - Labs business reported a strong growth of 7% in Q4 and 6% for the full year, representing 55% of total company revenue [6][18] - Immunohematology grew 3% for the full year, maintaining its leading global market position [18] - Triage business revenue increased by 16% in Q4 and 7% for the full year [18] - Respiratory revenue declined by 14% in Q4 and 20% for the full year due to lower COVID testing [18] Market Data and Key Metrics Changes - North America region revenue was up 4% in Q4 but down 2% for the year, excluding donor screening [19] - Europe, Middle East, and Africa (EMEA) growth was flat for the quarter and up 4% for the year, with a significant increase in Adjusted EBITDA margins by over 900 basis points [19] - Latin America saw a 17% increase in Q4 and 18% for the year, while Japan and Asia-Pacific grew 4% in Q4 and 6% for the year [19] - China grew 5% in Q4 and 3% for the full year [19] Company Strategy and Development Direction - The company established three priorities: customer-centric operations, strengthening operational and financial performance, and accelerating product development for long-term growth [5] - The focus is on optimizing the customer experience and driving effective execution across all business dimensions [9] - The company aims to maximize value by delivering superior outcomes for customers and converting that value into attractive returns for shareholders [8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to sustain growth, citing strong market positions and high renewal rates [34] - The company anticipates continued growth in the Labs business and expects to launch new products in 2026, including the VITROS 450 platform [14][15] - Management acknowledged challenges in cash flow conversion but emphasized ongoing efforts to improve cash flow and margin performance [88] Other Important Information - A significant non-cash goodwill impairment charge of $701 million was recorded in Q3, which does not impact cash or operations [21] - The CFO announced plans to retire in June, with a search for a successor already initiated [9] Q&A Session Summary Question: Free cash flow guidance and timing of cash collections - Management explained that Q4 cash flow was lower than expected due to timing issues with cash collections, with $45 million expected to be collected in Q4 but realized in January [30][31] Question: Sustainability of lab growth trends - Management expressed optimism about sustaining growth, highlighting strong market positions and opportunities in immunoassay and low market penetration [34] Question: Updates on China and dry slide procurement - Management stated there were no new updates regarding the nationalized VBP program for dry chemistry test strips in China, with potential impacts estimated at 0.5% to 1% of total revenue [40] Question: Margins and direct procurement initiatives - Management indicated that direct procurement initiatives are expected to improve margins over time, with a goal of reaching closer to 50% gross margin in the coming years [68][69]

QuidelOrtho Fourth Quarter and Full-Year 2025 Financial Results February 11, 2026 QuidelOrtho – Proprietary & Confidential. | © 2025. All Rights Reserved. 2 Forward-Looking Statements and Non-GAAP Financial Measures Forward-Looking Statements: This presentation of QuidelOrtho Corporation ("QuidelOrtho" or the "Company") contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are any statement contained herein that is not strictly his ...