CareDx Investor Webinar Call Summary Company Overview - **Company**: CareDx - **Focus**: Development of AlloHeme, an AI-enabled solution for relapse monitoring in Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS) post-cell therapy, aiming to lead in precision medicine for cell therapy [2][9] Key Points Industry Context - **Market Growth**: Solid organ transplantation is a growing market, driven by federal policies and technological advances, with CareDx capturing over 70% of the serviced market [9] - **Cell Therapy Market**: The cell therapy market is expanding rapidly, with allogeneic hematopoietic cell transplants (HCT) and CAR T-cell therapies being primary focuses. The market is expected to grow at a 9% CAGR for HCT and 30% for CAR T-cell therapies from 2024 to 2028 [14][15] AlloHeme Development - **Target Population**: AlloHeme is designed for high-risk patients with hematologic malignancies, particularly those undergoing allogeneic HCT and CAR T-cell therapies [10][12] - **Monitoring Solution**: AlloHeme utilizes next-generation sequencing to analyze micro changes in cell populations from peripheral blood samples, providing a non-invasive method for relapse prediction [17][18] - **Clinical Validation**: The ACROBAT trial demonstrated AlloHeme's high sensitivity (85%) and specificity (92%) for detecting relapse, with a median lead time of 41 days before clinical relapse [41][45] Market Opportunity - **Total Addressable Market (TAM)**: Estimated at approximately $1 billion, driven by an increasing patient population eligible for HCT, with 70% for AML and 45% for MDS [57] - **Commercialization Timeline**: CareDx plans to launch AlloHeme in early 2027, following the publication of the ACROBAT study and completion of CLIA readiness activities [60] Competitive Landscape - **Current Monitoring Tools**: Existing tools for relapse monitoring, such as chimerism testing and MRD approaches, have limitations in sensitivity and require invasive procedures like bone marrow biopsies. AlloHeme aims to fill this gap with a more sensitive, non-invasive alternative [23][24][49] Future Directions - **Standardization Goal**: CareDx aims for AlloHeme to become a standardized tool for monitoring relapse in post-allogeneic HCT patients, addressing the variability in current monitoring practices [63][64] - **Clinical Utility Evidence**: Future studies will focus on demonstrating the clinical utility of AlloHeme in improving health outcomes through earlier detection and intervention [64][66] Additional Insights - **Patient Journey**: The patient journey post-transplant involves intensive monitoring for relapse, with a significant gap in current practices due to the infrequency of sensitive assessments like bone marrow biopsies [21][22] - **Regulatory Considerations**: CareDx anticipates that coverage decisions for AlloHeme will begin in 2028, which will be crucial for market adoption [60] This summary encapsulates the key points discussed during the CareDx Investor Webinar Call, highlighting the company's strategic focus on AlloHeme and its potential impact on the cell therapy market.

Core Viewpoint - Biodesix, Inc. will release its financial results for Q4 and the full year of 2025 on February 26, 2026, followed by a conference call to discuss these results and provide a business update [1]. Company Overview - Biodesix is a leading diagnostic solutions company focused on improving clinical care and outcomes for patients, particularly in lung disease [3]. - The company offers diagnostic tests such as Nodify Lung Nodule Risk Assessment and IQLung Cancer Treatment Guidance, which aid in clinical decision-making [3]. - Biodesix Development Services support biopharmaceutical and life sciences institutions in developing diagnostic tests and therapeutics [3].

Core Insights - QuidelOrtho reported $2.73 billion in revenue for the full year, with non-respiratory revenue growing 5% and Labs business growing 6%, representing 55% of total revenue [1][6] - The company experienced a decline in respiratory revenue, totaling $402 million, primarily due to lower COVID testing [1][6] Financial Performance - For Q4, QuidelOrtho reported revenue of $724 million, a 2% year-over-year increase; excluding COVID and donor screening, revenue growth was 7% [2] - The company achieved $140 million in cost savings, expanded adjusted EBITDA margins to the low 20% range, and reported an adjusted EBITDA margin of 22% for 2025, a 240 basis point improvement year-over-year [3][6] - Adjusted diluted EPS was $0.46 in Q4 and $2.12 for the full year, representing a 15% growth year-over-year [6] Segment and Regional Performance - Labs revenue grew 7% in Q4 and 6% for the full year, driven by strength in clinical chemistry; respiratory revenue declined 14% in Q4 and 20% for the year [8][9] - North America revenue was up 4% in Q4 but down 2% for the year; Europe, Middle East, and Africa was flat in Q4 and up 4% for the year [9] Research and Development - Recent FDA clearances include a high-sensitivity Troponin I assay and a DAT direct anticoagulant test card; plans for the launch of the VITROS 450 platform are underway [5][10] - The Lex molecular platform is in the final stages of FDA review, designed for point-of-care applications [13] 2026 Outlook - Management guided for 2026 revenue of $2.7 billion to $2.9 billion, with expected growth in Labs and Immunohematology, and a decline in molecular diagnostics due to the discontinuation of the Savanna business [17][18] - Adjusted EBITDA is expected to be between $630 million and $670 million, implying an adjusted EBITDA margin of about 23.3% [19] Leadership Update - The CFO, Joe Busky, will retire in June, and the company has initiated a search for a successor [20]

Core Insights - QuidelOrtho Corporation reported a transition from COVID-driven volatility to a more stable and diversified diagnostics business in 2025, with expectations for continued growth and margin expansion in 2026 [1][2] Financial Performance Fourth Quarter 2025 Results - Total revenue reached $724 million, with non-respiratory revenue at $600 million, reflecting a 7% growth in constant currency [1] - Labs revenue grew by 8% as reported and 7% in constant currency, while respiratory revenue declined by 14% to $123 million due to lower COVID-19 testing [1][4] - Flu revenue increased by 6% both as reported and in constant currency [1] Full-Year 2025 Results - Total revenue for the year was $2.73 billion, with non-respiratory revenue at $2.33 billion, marking a 5% growth in constant currency when excluding Donor Screening [1][4] - Respiratory revenue was $402 million, down 20% from the previous year due to reduced COVID-19 testing [1] - Flu revenue grew by 3% both as reported and in constant currency [1] Financial Guidance for 2026 - The company anticipates total revenues between $2.7 billion and $2.9 billion for FY 2026, with adjusted EBITDA projected between $630 million and $670 million [1] - Adjusted EBITDA margin is expected to improve to 23.3%, with adjusted diluted EPS guidance set between $2.00 and $2.42 [1] Cost Management and Cash Flow - Cost-saving initiatives contributed to a significant margin expansion, with free cash flow expected to improve by over $200 million in 2026 [1] - The company reported a net loss of $130.7 million for Q4 2025, with a basic loss per share of $1.92 [3][4] Leadership Transition - Joseph M. Busky, the Chief Financial Officer, announced his retirement effective June 30, 2026, with plans for a smooth transition [1][2] Business Segments Performance - Labs revenue for FY 2025 was $1.51 billion, reflecting a 5.5% increase from the previous year [4] - Immunohematology revenue grew by 4.2% to $543.8 million, while Donor Screening revenue saw a significant decline of 54.3% [4]

Core Viewpoint - Insight Molecular Diagnostics Inc. has announced a registered direct offering of 4,525,976 shares of common stock at an offering price of $5.75 per share, expected to raise approximately $26 million before expenses [1][2]. Group 1: Offering Details - The offering is set to close on February 12, 2026, pending customary closing conditions [1]. - Lake Street Capital Markets, LLC is acting as the sole placement agent for the offering [2]. - The purchase price for pre-funded warrants is the same as the common stock price, minus an exercise price of $0.0001 per share [1]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized for general corporate purposes, particularly for research and development in the transplantation category [2]. - The company aims to expand its GraftAssure product line to include heart transplant rejection testing, in addition to kidney transplant rejection testing [3]. Group 3: Shareholder Participation - Bio-Rad Laboratories, Inc., a significant shareholder of Insight Molecular Diagnostics, participated in the offering on the same terms as other investors [3]. Group 4: Regulatory Information - The securities are being offered under a "shelf" registration statement filed with the SEC, which was declared effective on August 7, 2024 [4]. - A final prospectus supplement will be filed with the SEC and will be available on their website [4]. Group 5: Company Overview - Insight Molecular Diagnostics is focused on democratizing access to novel molecular diagnostic testing to improve patient outcomes [6]. - The company offers various products, including GraftAssureCore™, GraftAssureIQ™, and others [6].

Core Viewpoint - Quest Diagnostics has received a stock upgrade to "Buy" from Jefferies, reflecting confidence in its financial health and growth prospects, with a price target increase from $215 to $220 [1][6] Financial Performance - In Q4 2025, Quest Diagnostics reported revenues of $2.81 billion, a 7.1% increase from the previous year, with diluted EPS rising by 11.8% to $2.18 and adjusted EPS at $2.42 [2] - For the full year 2025, the company achieved revenues of $11.04 billion, an 11.8% increase from 2024, with diluted EPS at $8.75 (up 13.8%) and adjusted EPS at $9.85 (up 10.3%) [3] Future Projections - Quest Diagnostics projects 2026 revenues between $11.70 billion and $11.82 billion, with expected diluted EPS between $9.45 and $9.65, and adjusted EPS ranging from $10.50 to $10.70, supported by strategic focus on clinical innovations [4] Shareholder Returns - The company announced a 7.5% increase in its quarterly dividend to $0.86 per share, marking the 15th consecutive year of dividend increases, and authorized a $1 billion increase in its share repurchase program [5][6]

Market Overview - The S&P 500 is down by 0.1% but remains near record highs, with defensive sectors gaining traction [2] - The ten-year Treasury yield has decreased by almost six basis points to 4.14%, influenced by weak retail sales data, which strengthens the case for potential Fed rate cuts [3][5] - Bitcoin has experienced volatility, currently trading just below $69,000 after reaching $60,000 last week [4] Economic Indicators - December retail sales showed stagnation, with eight out of thirteen retail categories reporting declines, indicating potential weakness in consumer spending [5][20] - The upcoming January jobs report is anticipated to provide further insights into the labor market, with a consensus estimate of 65,000 new jobs, although a whisper number suggests only 40,000 [26][28] Company Insights - Goldman Sachs CEO David Solomon expressed confidence in the U.S. economy, suggesting that the recent drop in software stocks may have been overdone [6][7] - Quest Diagnostics reported a record high in shares following strong earnings, raising its dividend and issuing a higher-than-expected adjusted EPS forecast for 2026 [30][31] - The consumer health segment of Quest Diagnostics is projected to grow over 20% this year, driven by increased consumer interest in preventive health measures [36][37] Sector Performance - Small-cap stocks, represented by the Russell 2000, have outperformed large-cap stocks, with a 21% rally over the past six months compared to a 9% gain for the S&P 500 [9][10] - The software sector has seen a significant valuation rerating of about 40% recently, despite facing scrutiny and volatility [15][19] - The healthcare sector, particularly in diagnostics and chronic disease management, is experiencing growth due to rising rates of chronic conditions and advancements in testing technologies [32][44] Future Outlook - The U.S. economy is transitioning from labor force growth to productivity-led growth, with generative AI adoption contributing to a productivity growth rate of 2% over the past few years, surpassing pre-COVID levels [25][98] - CVS is facing challenges due to flat Medicare Advantage rates, which could impact its growth trajectory, particularly as it targets mid-teens EPS growth through 2028 [52][54] - Becton Dickinson's recent merger with Waters aims to position the company as a leader in the life sciences space, focusing on AI and robotics to enhance healthcare delivery [67][68]

Jim, thank you for joining me. Uh, you take a look at the results that you delivered this morning. You boosted your adjusted profit and revenue uh, outlook for 2026.Your shares hitting a record high this morning as well. Talk us through the main growth drivers that you see when you take a look over the course of this year. >> Yeah.Uh, first Katie, thanks for having us on this morning. Um, you know, in terms of the growth drivers, um, we really think there's two or three major things going on. one um unfortu ...

Core Insights - BillionToOne has launched expanded non-invasive prenatal tests (NIPT) for fetal antigen status, specifically targeting hemolytic disease of the fetus and newborn (HDFN) and fetal and neonatal alloimmune thrombocytopenia (FNAIT) [1][4] - The new tests are designed to provide early and accurate determination of fetal antigen status, with over 99.9% sensitivity and specificity, and 100% concordance with neonatal outcomes [2][5] - The expanded offerings include 10 additional red blood cell antigens, covering approximately 99% of antigens associated with HDFN, thus reshaping the standard of care for these conditions [2][3] Company Developments - BillionToOne's UNITY Fetal Antigen NIPT has contributed to recent clinical guideline changes, recommending cfDNA testing for determining fetal antigen status, which reduces unnecessary surveillance for antigen-negative fetuses [3] - The company aims to address clinical gaps in managing platelet antigen incompatibility by introducing the first-ever Platelet Fetal Antigen NIPT, which allows for non-invasive determination of platelet antigen incompatibility in at-risk pregnancies [4][5] - The new tests are expected to redefine care for alloimmune fetal conditions by enabling proactive risk stratification and focusing resources on truly at-risk fetuses [5] Market Context - HDFN and FNAIT affect approximately 1.5-2.5% of pregnancies in the U.S., indicating a significant market opportunity for innovative diagnostic solutions [1] - The introduction of these tests is positioned to close existing gaps in prenatal care, particularly in cases where traditional monitoring methods are inadequate [4][5] - BillionToOne's advancements in molecular diagnostics are set to enhance clinical decision-making and improve patient outcomes in prenatal care [5]

Core Viewpoint - Co-Diagnostics, Inc. will participate in the World Health Expo Labs Dubai to showcase its molecular diagnostic technologies and engage with regional stakeholders, following the establishment of a joint venture to enhance its market presence in the Middle East and North Africa [1][3]. Company Participation - The exhibition will take place from February 10–13, 2026, at the Dubai World Trade Centre, where Co-Diagnostics will have a booth (S17.C79) [3]. - The participation aligns with the company's strategy to expand access to high-quality molecular diagnostics in the region [3]. Joint Venture - Co-Diagnostics has formed a joint venture named CoMira Diagnostics with Arabian Eagle Manufacturing in Saudi Arabia, aimed at localizing the manufacturing and distribution of its technologies across Saudi Arabia and 18 additional countries in the MENA region [3]. Product Information - The Co-Dx PCR platform, which includes various applications and tests, is currently undergoing clinical studies in the United States and is subject to regulatory review [5][6]. - The company's technologies focus on the detection and analysis of nucleic acid molecules (DNA or RNA) for various diagnostic applications [6].