证券分析师：陈曦炳 0755-81982939 chenxibing@guosen.com.cn S0980521120001 证券分析师：彭思宇 0755-81982723 pengsiyu@guosen.com.cn S0980521060003 请务必阅读正文之后的免责声明及其项下所有内容 报告摘要 请务必阅读正文之后的免责声明及其项下所有内容 2026年02月02日 证券研究报告 | 2026年02月02日 创新医疗器械盘点系列（4） 肿瘤基因检测的"勇敢者游戏"（上篇） 公司研究 · 深度报告 医药生物 · 医疗器械 投资评级：优于大市（维持） 证券分析师：张超 0755-81982940 zhangchao4@guosen.com.cn S0980522080001 2 ◼ 缘起：肿瘤基因检测行业处于发展快车道。2025年四季度至今肿瘤基因检测领域热点不断，国际重磅交易频出，国内监管革新。2025 年美国肿瘤基因检测龙头股价涨势良好，Natera/Exact Science/Guardant/Grail年度股价涨幅分别达到52%/78%/221%/464%。国际体 外诊断龙头常规业务增长乏力，而肿 ...

Company Overview - GRAIL has made significant progress since launching Galleri in 2021, which allows individuals and their physicians to detect cancers before symptoms appear, often at earlier stages [3] - Galleri is recognized as the first multi-cancer early detection test, establishing a new paradigm in cancer screening [3] Product Performance - The performance of Galleri has been validated through various studies, including a recent analysis involving the first 25,000 participants [3]

Summary of GRAIL's Conference Call Company Overview - **Company**: GRAIL - **Product**: Galleri, a multi-cancer early detection test launched in 2021 - **Industry**: Cancer screening and diagnostics Key Points and Arguments Business Progress and Financials - GRAIL has completed over 800,000 Galleri tests and sold more than 185,000 tests in 2025, indicating strong commercial momentum [4][7] - Revenue for 2025 is projected to be between $147 million and $148 million, representing a growth of approximately 17%-18% over 2024 [9] - The company ended 2025 with $904 million in cash, providing a strong capital position for future growth [5] - Cash burn for 2025 was approximately $274 million, significantly reduced from $579 million in 2024 due to organizational restructuring [10] Market Expansion and Partnerships - GRAIL plans to expand Galleri in the U.S. and international markets, with partnerships established in Israel, Canada, and South Korea [9][24] - The prescriber base grew by approximately 30% in 2025, reaching over 17,000 prescribers, indicating increased adoption among healthcare providers [7] - The company is working with operational partners like Quest and Athena to streamline test ordering and execution [8] Clinical Validation and Performance - Galleri is the only multi-cancer early detection test with published validation data in the intended use population, demonstrating a positive predictive value of 62% and a false positive rate of 0.4% [14][20] - The PATHFINDER 2 study showed a seven-fold increase in cancer detection rates when Galleri was added to standard screenings, with over half of detected cancers found at early stages [19][20] - The test is designed to detect over 100 types of cancer, significantly more than the 14% detection rate of current single cancer screenings [12][15] Future Outlook and Regulatory Plans - GRAIL expects to file for PMA (Pre-Market Approval) in Q1 2026 and present full data sets from major studies in mid-2026 [6][21] - The company anticipates total Galleri revenue growth of 22%-32% in 2026, with cash burn expected to be less than $300 million [10] Strategic Vision - GRAIL aims to transform cancer screening by moving away from individual cancer tests to a comprehensive approach that detects multiple cancers simultaneously [12][13] - The company emphasizes the importance of clinical utility and aims to demonstrate the reduction of late-stage cancer incidence through its testing [22][24] Additional Important Insights - GRAIL's automated lab infrastructure allows for a testing capacity of one million samples per year, with plans for further expansion [18] - The company is focused on achieving FDA approval, which is expected to enhance market adoption and reimbursement opportunities [24] - GRAIL's strategy includes leveraging consumer empowerment trends in healthcare, which may increase self-pay market growth for preventive services like Galleri [24] This summary encapsulates the key points discussed during the conference call, highlighting GRAIL's business progress, market strategies, clinical validation, and future outlook in the cancer screening industry.

Group 1 - Grail Inc. (NASDAQ:GRAL) experienced a significant increase of 379.5 percent in 2025, driven by positive analyst ratings and confidence in its early cancer detection test kit, Galleri [1] - Galleri is a single blood test designed to screen over 50 types of cancer, with a reported positive predictive value of 61.6 percent from its Pathfinder 2 clinical study [1] - Samsung group has backed Grail Inc. for the exclusive distribution of Galleri in South Korea and other key Asian markets, acquiring a $110 million stake at a price of $70.05 per share [2] Group 2 - Analysts have shown optimism towards Grail Inc., with Canaccord issuing a "buy" recommendation and raising its price target to $105, while Morgan Stanley increased its target to $110, maintaining an "equal weight" rating [2] - Grail Inc. plans to seek FDA pre-market approval for Galleri within the first quarter of 2026 [2]

Summary of Conference Call on Grail's MCED Technology Company Overview - **Company**: Grail - **Industry**: Multi-Cancer Early Detection (MCED) technology - **Founded**: 2015 - **Key Product**: Galleri test for early cancer detection Core Points and Arguments Market Position and Technology - Grail is recognized as the oldest MCED company, aiming to revolutionize cancer detection by addressing the limitations of current single cancer screening tests, which only detect about 14% of all cancers, while 80% of cancer deaths arise from undetected cancers [2][3] - The company has developed innovative technology validated through rigorous studies, including randomized clinical trials, to seek FDA approval, which is seen as a competitive advantage [3][4] FDA Approval and Data Submission - Grail is in the process of a modular PMA submission to the FDA, expected to be completed in Q1 2026, involving over 100,000 subjects, making it one of the largest data submissions for a diagnostic test [5][6] - The test detects methylated DNA signals in blood, providing high specificity for cancer with a low false positive rate [6][10] Performance Metrics - The Galleri test has a false positive rate of 0.4%, significantly lower than traditional tests, and a positive predictive value of 62% [10][11] - In trials, adding Galleri to standard care increased cancer detection rates by over sevenfold, with over half of detected cancers in stages one and two [9][10] Market Strategy and Growth - Grail anticipates strong demand for Galleri in 2026 and 2027, with plans for annual testing to ensure early detection of rapidly progressing cancers [13][26] - The company is exploring partnerships with digital health platforms and self-pay markets, which are expected to grow as consumers gain more control over their healthcare spending [15][16] Reimbursement and Legislative Context - Currently, about 60% of Grail's business is self-pay, with 30%-40% reimbursed by employers and life insurance partners [19] - The company is optimistic about gaining Medicare coverage following FDA approval, contingent on pending MCED legislation [20][21] Competitive Landscape - Grail welcomes new entrants in the MCED market, such as Exact Sciences and Guardant Health, but maintains that its product performance and validation in screening populations provide a significant competitive edge [22][23] International Expansion - Grail has launched its product in Canada and Israel, with plans for further expansion in Asia through a partnership with Samsung [32][33] - The company expects international markets to contribute to revenue growth, albeit at a slower pace compared to the U.S. market [32] Financial Outlook - Grail has raised $325 million through a PIPE and anticipates additional funding from Samsung, which will support operations into 2030 [34] - The company aims to optimize costs and improve gross margins as it scales operations [27][29] Additional Important Insights - The NHS Galleri study, anticipated for mid-2026, is expected to provide significant data that could influence market access in the U.K. and beyond [24][25] - Grail's focus on interventional studies rather than solely case-control studies is highlighted as a critical differentiator in ensuring the safety and efficacy of its product [11]

Core Insights - Grail is a leader in the multi-cancer early detection (MCED) market, with its stock rising 20.1% in November following positive third-quarter results and an analyst day [1] Company Overview - Grail's Galleri test screens for over 50 types of cancer and is the first MCED available commercially, although it has not yet received FDA approval, which management aims to achieve by the first half of 2026 [2] - The company faces competition from larger firms like Exact Sciences, which has its own MCED product, CancerGuard [2] Strategic Goals - Grail aims to grow commercial sales of Galleri while reducing cash burn, with a reported 39% year-over-year growth in Galleri tests in Q3, generating $32.6 million in revenue [3] - Cash burn has decreased to $59 million from $71.8 million in the previous quarter and $105.2 million a year ago [3] Financial Position - Following a successful private placement, Grail has a cash position of $850 million with no long-term debt, providing significant resources ahead of potential FDA approval for Galleri [4] Market Dynamics - The recent acquisition of Exact Sciences by Abbott Labs for a substantial premium underscores the attractiveness of the MCED market, raising speculation about potential acquisitions, including Grail [5] - Grail's Galleri test offers significant benefits for early cancer detection, positioning the company as a strong candidate for acquisition by larger firms [6] Acquisition Potential - Larger companies are likely to acquire firms like Grail and Exact Sciences due to their resources and market presence, with Grail being viewed as a more attractive acquisition target compared to Exact Sciences, which already has an FDA-approved product [7]

Summary of Exact Sciences FY Conference Call - November 14, 2025 Industry Overview - The conference is part of the seventh annual Healthcare Symposium, focusing on healthcare investment and innovations in cancer detection and treatment [1][2] - The aging population is a significant concern, with the percentage of individuals aged 65 and older increasing, necessitating better healthcare solutions [2] - U.S. healthcare spending is projected to rise from 18% of GDP to 20% by the early 2030s, driven by the burden of diseases like cancer [3] Key Points on Cancer Detection and Treatment - Cancer cases are expected to rise significantly, with projections of over 35 million cases and 18.5 million deaths by 2050 [3] - The symposium discusses the importance of early cancer detection, particularly through multi-cancer early detection (MCED) technologies [10][52] - Advances in treatment have shifted cancer from a death sentence to a manageable chronic disease, emphasizing the need for early detection [10] Company-Specific Insights Exact Sciences - Exact Sciences aims to prevent cancer, detect it earlier, and optimize treatment, with a focus on expanding from colorectal cancer to multiple cancers [14][15] - The flagship product, Cologuard, has screened over 20 million people, significantly impacting survival rates [27] - Exact Sciences is developing a multi-cancer early detection test, which is seen as complementary to existing screening methods [28] Quest Diagnostics - Quest emphasizes access to innovative cancer detection technologies and partnerships with various organizations to enhance screening capabilities [12][31] - The company is developing a multi-cancer risk test in collaboration with MD Anderson, focusing on identifying cancer risk through circulating tumor proteins [35] Guardant Health - Guardant's mission is to conquer cancer with data, focusing on early-stage detection and utilizing a common tech stack for various cancer indications [16][17] - The company is actively involved in trials for detecting multiple cancers, starting with colorectal cancer [21][24] Grail - Grail was founded to develop blood tests capable of detecting multiple cancers, with its product Galleri able to detect up to 50 cancers [18][19] - The company emphasizes the importance of education in shifting the market towards multi-cancer screening [20] Economic and Healthcare Implications - Early detection through MCED could reduce stage four cancer incidence by over 40% and overall cancer mortality by 18% [57] - The cost of detecting cancer at earlier stages is significantly lower than at later stages, highlighting the economic benefits of early screening [58] - The healthcare system must adapt to recognize the value of diagnostics, which are currently undervalued compared to treatment interventions [62] Challenges and Future Directions - The panelists discussed the need for collaboration with insurance companies and government to align incentives for early testing [60][65] - There is a focus on developing evidence strategies to demonstrate the clinical utility of MCED tests to secure reimbursement [65] - The potential for early detection of pancreatic cancer is promising, with technologies showing high performance in identifying this type of cancer [76][78] Conclusion - The symposium highlighted the collaborative efforts among various companies to advance cancer detection technologies and improve patient outcomes through early intervention and innovative partnerships [9][46]

Summary of Guardant Health FY Conference Call Company and Industry Overview - **Company**: Guardant Health (NasdaqGS:GH) - **Industry**: Healthcare, specifically focusing on oncology and multi-cancer early detection Key Points and Arguments 1. **Aging Population and Healthcare Spending**: The aging population is increasing, with the percentage of people aged 65 and older projected to grow significantly. Healthcare spending in the U.S. is currently about 18% of GDP and is expected to rise to 20% by the early 2030s, necessitating innovative solutions in healthcare delivery [3][4][5] 2. **Cancer Statistics**: There are currently around 20 million cancer cases and nearly 10 million deaths, projected to rise to over 35 million cases and 18.5 million deaths by 2050. This highlights the urgent need for advancements in cancer detection and treatment [4] 3. **Multi-Cancer Early Detection (MCED)**: The symposium focused on the future of multi-cancer screening, emphasizing the importance of early detection in improving treatment outcomes and reducing mortality rates. Early detection is seen as a key strategy in managing cancer as a chronic disease rather than a terminal one [11][12][54] 4. **Panelist Contributions**: - **Guardant Health**: Focuses on conquering cancer with data, utilizing a common tech stack for various cancer stages and indications. The company emphasizes the importance of early detection through blood tests [18][19][43] - **Exact Sciences**: Aims to prevent cancer and optimize treatment, with a strong focus on colorectal cancer through its Cologuard product. The company is expanding into multi-cancer early detection [16][30] - **Quest Diagnostics**: Highlights the importance of access to innovative testing and the integration of various health dimensions beyond cancer [14][32] - **Grail**: Developed the Galleri test, capable of detecting up to 50 cancers through blood samples, emphasizing the shared signals across different cancer types [20][21] 5. **Economic Impact of Early Detection**: Exact Sciences conducted a health economic model showing that implementing MCED could reduce stage four cancer incidence by over 40% and overall cancer mortality by 18%. Early detection is significantly less expensive than late-stage treatment [57][58] 6. **Partnerships and Collaboration**: The importance of partnerships among companies, healthcare providers, and payers is emphasized to enhance access, streamline processes, and improve patient outcomes. Collaboration is seen as essential for developing effective screening protocols and ensuring patient follow-up [38][60] 7. **Challenges in Implementation**: The panelists discussed the challenges of integrating new testing methods into existing healthcare systems, including the need for education among healthcare providers and patients, as well as the necessity of aligning incentives with payers [42][66] 8. **Future Directions**: The discussion included the potential for advancements in detecting precancerous conditions and the need for ongoing research and partnerships to improve early detection technologies [72][73] Other Important Content - **Vaccine Access**: The symposium also touched on the disparities in vaccine access, with higher-income individuals purchasing a disproportionate share of vaccines, highlighting the need for improved access for lower and middle-income populations [5] - **Healthcare System Navigation**: The complexity of the healthcare system necessitates effective navigation strategies to ensure patients receive timely follow-up care after initial screenings [41][52] This summary encapsulates the critical discussions and insights shared during the Guardant Health FY Conference Call, focusing on the advancements and challenges in the field of oncology and early cancer detection.

Summary of Quest Diagnostics FY Conference Call Company and Industry Overview - **Company**: Quest Diagnostics (NYSE: DGX) - **Industry**: Healthcare, specifically focusing on diagnostics and cancer detection Key Points and Arguments 1. **Healthcare Spending Trends**: - U.S. healthcare spending is currently about 18% of GDP, projected to rise to 20% by the early 2030s [4][4] - The aging population is a significant factor driving healthcare costs, with a notable increase in individuals aged 65 and older [3][3] 2. **Cancer Statistics**: - Current cancer cases are around 20 million with nearly 10 million deaths, expected to rise to over 35 million cases and 18.5 million deaths by 2050 [4][4] - Early detection is emphasized as a critical factor in improving cancer outcomes [11][11] 3. **Multi-Cancer Early Detection (MCED)**: - Quest Diagnostics is focusing on three dimensions for early cancer detection: access to innovation, innovative testing, and whole health considerations [13][13] - The company is developing a multi-cancer risk test in partnership with MD Anderson, aimed at identifying cancer risk through circulating tumor protein assays [47][47] 4. **Panel Discussions**: - Various companies, including Exact Sciences, Guardant Health, and Grail, discussed their approaches to MCED, highlighting the importance of early detection and the need for complementary testing strategies [16][16][20][20] - Grail's Galleri test can detect up to 50 cancers through blood samples, showcasing advancements in technology for early detection [20][20] 5. **Partnerships and Collaborations**: - Quest has established partnerships with multiple organizations to enhance access to cancer screening and testing [42][42] - The importance of collaboration with healthcare providers, payers, and technology partners is emphasized to improve patient access and compliance with screening [50][50] 6. **Economic Impact of Early Detection**: - A health economic model indicated that implementing MCED could reduce stage four cancer incidence by over 40% and overall cancer mortality by 18% [68][68] - Early detection is projected to be significantly less expensive than late-stage treatment, reinforcing the economic benefits of proactive screening [68][68] 7. **Challenges in Implementation**: - The healthcare ecosystem faces challenges in aligning incentives for early detection tests, requiring robust evidence to support reimbursement from payers [70][70] - The need for education and awareness among consumers and healthcare providers is critical to increase adoption of MCED tests [51][51] 8. **Future Directions**: - The panelists discussed the potential for transforming cancer care through MCED, emphasizing the shift towards outpatient follow-up and less invasive procedures [63][63] - There is a focus on developing real-world evidence to support the efficacy and utility of early detection tests in clinical settings [86][86] Additional Important Content - The symposium highlighted the growing importance of addressing healthcare challenges related to an aging population and rising cancer incidence [3][3] - The discussions underscored the need for innovative solutions and collaborative efforts to improve cancer detection and treatment outcomes [49][49]

Summary of GRAIL Analyst Day - November 13, 2025 Company Overview - **Company**: GRAIL (NasdaqGS:GRAL) - **Industry**: Multi-Cancer Early Detection (MCED) Testing Key Highlights 1. **Introduction and Purpose**: The Analyst Day aimed to share key business highlights and progress since GRAIL became a public company in June 2024, focusing on population-scale multi-cancer early detection [8][9][10] 2. **Financial Performance**: - Revenue for 2024 was $125 million, with a growth rate of 25% year-over-year for the first nine months of 2025 [12] - A $325 million PIPE financing was announced, providing capital for future growth [13] - Cash burn for the year was reduced to $290 million, with improved margins increasing to 55% from 41% the previous year [14] 3. **Operational Capacity**: GRAIL's lab can run up to 1 million tests, showcasing significant automation and efficiency improvements [12][15] Clinical and Research Insights 1. **Cancer Detection Landscape**: - Cancer is projected to become the leading cause of death globally, surpassing cardiovascular disease [16] - The current screening tests only detect about 14% of incident cancers, generating over 8 million false positives annually in the U.S. [23][24] 2. **Galleri Test Performance**: - The Galleri test has shown a positive predictive value (PPV) of 62% in the PATHFINDER II study, significantly higher than traditional single cancer screening methods [21][32] - The specificity of the Galleri test was reported at 99.6%, minimizing false positives [33] - Episode sensitivity for all cancers was 40.4%, with higher sensitivity for cancers responsible for two-thirds of U.S. cancer deaths at 74% [34] 3. **PATHFINDER II Study**: - Enrolled nearly 35,000 participants, making it the largest interventional MCED study in the U.S. [30] - The study demonstrated that the Galleri test could detect cancers earlier, with 69% of identified cancers being in early stages [36] - The study also showed a low rate of invasive procedures (0.6%) due to positive test results, indicating a favorable safety profile [37] Future Directions 1. **FDA Submission**: GRAIL plans to submit data from the PATHFINDER II study to the FDA by Q1 2026, aiming for Galleri to be the first FDA-approved MCED test [26][27] 2. **NHS-Galleri Study**: A large-scale study in the UK involving 140,000 participants is underway to assess the utility of the Galleri test in a screening population [42][43] 3. **Reimbursement Pathways**: Discussions on alternative reimbursement strategies, including potential use as a surveillance tool for high-risk populations, are ongoing [66] Additional Insights - The importance of building a robust evidence base for the Galleri test was emphasized, with a focus on clinical validation and performance rather than mortality outcomes [57][58] - The potential for Galleri to complement existing single cancer screening tests was highlighted, aiming to improve overall cancer detection rates and reduce healthcare costs associated with false positives [24][25] This summary encapsulates the critical points discussed during the GRAIL Analyst Day, focusing on the company's advancements in cancer detection technology and its strategic direction moving forward.