Summary of Natera FY Conference Call - September 23, 2025 Company Overview - **Company**: Natera (NasdaqGS:NTRA) - **Industry**: Life Sciences Tools and Diagnostics Key Points Market Opportunity - The addressable market for Minimal Residual Disease (MRD) testing is significant, with approximately 2 million cancer diagnoses annually in the U.S. [9] - It is estimated that 1.5 million of these diagnoses are relevant for MRD and recurrence monitoring, leading to a potential total addressable market (TAM) of around $30 billion based on an average selling price (ASP) of $2,000 per test [12] - Current revenue from Signatera is projected to be around $1 billion, indicating substantial growth potential [12] Product and Technology - Natera's Signatera test is positioned as a leader in MRD testing, with a focus on identifying cancer recurrences earlier than traditional methods [22] - The company is developing a tumor-naive test, Latitude, to address patients without viable tissue samples, which represents an unmet need in the market [51] - The blended cost of goods sold (COGS) for Signatera is competitive, allowing for sustainable growth and investment in clinical trials [14][60] Clinical Trials and Evidence Generation - Natera is conducting multiple clinical trials to build evidence for the clinical utility of Signatera, including a Phase III trial in muscle invasive bladder cancer [24] - The company emphasizes the importance of prospective clinical trials to demonstrate the effectiveness of their tests, which is crucial for adoption by physicians [42][43] Competitive Landscape - The company acknowledges the presence of competition in the MRD testing space but believes that their focus on solving unmet patient needs will differentiate them [36] - Natera's strategy involves leveraging their existing relationships in oncology and primary care to enhance market penetration [68] Future Outlook - Natera anticipates that the adoption of MRD testing will increase as more data becomes available, and they expect to see a rise in ASP as reimbursement becomes more consistent [57] - The company is optimistic about the future of their products and believes that the market has not fully priced in the potential of Signatera [79] Additional Insights - The company is aware of the challenges in the blood-based early cancer detection market, particularly for colorectal cancer, and is focused on addressing these challenges through innovative solutions [67] - Natera's leadership emphasizes the importance of transparency and data sharing with investors to build trust and confidence in their products [70] Conclusion Natera is positioned for significant growth in the MRD testing market, with a strong focus on clinical evidence, competitive differentiation, and addressing unmet patient needs. The company is optimistic about future adoption and market potential, despite existing competition.

Core Insights - Illumina has launched TSO 500 v2, an advanced assay that enhances tumor profiling capabilities with built-in HRD detection, faster turnaround times, and reduced tissue requirements [1][2] - The assay assesses hundreds of genes and immuno-oncology biomarkers, facilitating personalized treatment and improving patient outcomes when used early in cancer diagnosis [1] Product Enhancements - TSO 500 v2 includes HRD status analysis at no additional cost, utilizing a Genomic Instability Scoring (GIS) algorithm from Myriad Genetics, expanding research into HRD biomarkers across various cancer types [2] - The new workflow is designed to be faster and more efficient, with improved accuracy compared to previous solutions from other vendors [4] - The updated packaging and kit configuration reduce the number of boxes and tubes, enhancing user experience and minimizing errors during the workflow [5] Workflow Efficiency - The streamlined workflow reduces turnaround time and hands-on time, with sensitive variant calling and better coverage of difficult genomic regions [7] - New kit configurations feature 50% less packaging and 70% fewer tubes, improving sustainability and usability with a color-coded tubing system [7] - Integrated data analysis is supported by DRAGEN™ secondary analysis and Illumina Connected Insights, with compatibility across various sequencers [7] Strategic Partnerships - Illumina has partnered with Pillar BioSciences to offer targeted molecular profiling tests, including the upcoming Pillar oncoReveal CDx IVD kit [8]