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，而肿瘤基因检测行业维持高景气度。肿 瘤基因检测有望覆盖肿瘤早期筛查、辅助诊断、伴随诊断、疗效监测、复发预测等肿瘤精准治疗全流 程。随着肿瘤MRD、多癌早筛的应用逐步成熟，各应用场景的可及市场规模将呈数倍扩大。 Exact Science：肠癌早筛的领军企业 Exact Sciences是一家全球领先癌症筛查与诊断公司，核心业务是肠癌筛查产品Cologuard。公司2025年 业绩指引为收入32.2-32.35亿美元(+16.7-17.2%)，中期目标(2022-27年)为收入复合增速15%和2027年超 过20%的经调整EBITDA利润率。 美国肠癌筛查的可及市场大约对应1.2亿45-85岁平均风险人群，目前已筛查人群约7000万，其中肠镜占 比77%，Cologuard占比13%。Cologuard的未来增长动力可拆解为：1) ...

证券研究报告 | 2026年02月03日 | 晨会纪要 | | --- | | 数据日期:2026-02-02 | 上证综指 | 深证成指沪深 | 300 指数 | 中小板综指 | 创业板综指 | 科创 50 | | --- | --- | --- | --- | --- | --- | --- | | 收盘指数（点） | 4015.74 | 13824.35 | 4605.97 | 14945.45 | 4041.36 | 1450.89 | | 涨跌幅度（%） | -2.48 | -2.68 | -2.13 | -2.30 | -2.49 | -3.87 | | 成交金额（亿元） | 11635.32 | 14212.32 | 7259.20 | 4906.84 | 6768.90 | 865.95 | $$\overline{{{\mathbb{M}}}}\cong\pm\overline{{{\mathbb{M}}}}$$ (4) [ (4) 384938 1 宏观与策略 固定收益深度:固收+系列之十二-多资产图谱及固收+投资组合构建 策略快评:市场调整的原因及性质 策略周报:ETF 净赎回规模收窄— ...

Investment Rating - The report maintains an "Outperform" rating for the tumor gene testing industry [1] Core Insights - The tumor gene testing industry is on a fast development track, with significant international transactions and domestic regulatory innovations occurring since Q4 2025. The market is expected to expand significantly as applications for tumor MRD and multi-cancer early screening mature [2][6] - Exact Sciences is a leading company in colorectal cancer screening, projecting revenues of $3.22 to $3.235 billion for 2025, representing a growth of 16.7% to 17.2%. The company aims for a compound annual growth rate (CAGR) of 15% from 2022 to 2027 [2][18] - Natera is recognized as a leader in minimal residual disease (MRD) testing, with its core product, Signatera, achieving a sample volume of over 200,000 in Q3 2025, reflecting a year-on-year growth of 54% [2][68] - The report emphasizes the importance of monitoring technological advancements and the positioning of leading companies in the tumor gene testing sector [2] Summary by Sections 1. Tumor Gene Testing Industry Overview - The tumor gene testing sector is experiencing rapid growth, with significant stock price increases for leading companies such as Natera (52%), Exact Science (78%), Guardant (221%), and Grail (464%) in 2025 [2][6] - The market is projected to expand significantly, with potential market sizes for early screening (multi-cancer MCED and colorectal cancer) estimated at $40-50 billion, MRD at $15-20 billion, and companion diagnostics/treatment guidance at $3-5 billion [11][12] 2. Exact Sciences: Colorectal Cancer Screening Leader - Exact Sciences has established a robust medical ecosystem with a testing capacity exceeding 10 million annually. Its core product, Cologuard, has a brand recognition rate of over 90% [18] - The company anticipates maintaining a revenue growth rate of 15% and aims for an adjusted EBITDA margin exceeding 20% by 2027 [18][24] - Cologuard's future growth drivers include rescreening, addressing care gaps, pricing increases for the Plus version, and expanding into younger demographics [45][48] 3. Natera: Leader in MRD Testing - Natera's MRD product, Signatera, is pivotal in assessing treatment efficacy and guiding clinical decisions, with a significant focus on ctDNA mutation detection [2][68] - The company is expanding its presence in women's health and organ health, while also entering the colorectal cancer screening market [2][68] 4. Domestic Company Landscape and Investment Recommendations - The report highlights the innovative developments from domestic companies such as Aide Biology, BGI, and Mirxes, which are making strides in lung cancer MRD products and multi-cancer early screening [2] - The report suggests monitoring the technological advancements and market positioning of these domestic leaders as the industry evolves [2]

Core Insights - The Healthcare Technology Report announced the Top Healthcare Technology CEOs of 2025, highlighting the evolving expectations for technology in healthcare, focusing on integration, reliable outcomes, and expansion beyond initial deployments [2][5] Company Performance - Natera reported preliminary 2025 results of approximately $2.3 billion in revenue and processed around 769,700 clinical MRD tests, indicating significant adoption of its Signatera product [3] - BillionToOne, under the leadership of Oguzhan Atay, successfully completed a NASDAQ IPO in November 2025, advancing single-molecule counting to a broader commercial stage [4] - Angle Health, led by Ty Wang, secured a $134 million Series B financing, expanding its healthcare benefits technology platform to over 3,000 employers across 44 states [4] Leadership Recognition - The awardees for the Top Healthcare Technology CEOs of 2025 include notable leaders such as Steve Chapman (Natera), Oguzhan Atay (BillionToOne), and Ty Wang (Angle Health), among others, who have contributed to enhancing healthcare connectivity and efficiency [6][5]

Market Overview - The US equity market ended Q4 2025 positively, with the S&P 500 increasing by 2.7%, reflecting steady upward momentum [1] - Investor optimism was bolstered by better-than-expected corporate earnings, the US Federal Reserve's interest rate easing stance, and a resilient macroeconomic backdrop [1] - Clarity on trade policy provided additional support, although there was increasing divergence below the index level [1] Investment Trends - There is growing skepticism regarding AI investments due to bottlenecks, financing challenges, and uncertainty about return generation [1] - The firm continues to identify secular trends that present attractive investment opportunities for small-cap stocks [1] Fund Performance - In Q4 2025, Class A shares of the Alger Small Cap Focus Fund outperformed the Russell 2000 Growth Index [1] - The Utilities and Financials sectors contributed positively to the Fund's performance, while the Consumer Discretionary and Information Technology sectors detracted from it [1] Company Spotlight: Natera, Inc. - Natera, Inc. (NASDAQ:NTRA) is highlighted as a leading diagnostics and research company specializing in molecular testing services [2][3] - The stock had a one-month return of -0.31% but gained 46.03% over the last 52 weeks, closing at $231.25 per share with a market capitalization of $32.248 billion on January 16, 2026 [2] - Natera provides high-value genetic testing across reproductive health, oncology, and transplant, utilizing a proprietary cell-free DNA liquid biopsy platform [3] - The company reported strong fiscal Q3 earnings, with management indicating revenue and margin performance exceeding expectations due to higher test volumes and favorable reimbursement dynamics, particularly in the Signatera franchise [3]

Core Insights - Natera's mission is to transform disease management globally through proprietary technology that detects minute quantities of DNA, combining molecular and bioinformatics techniques [2] - The company launched its first product, Panorama, in 2013, a cell-free fetal DNA test for chromosomal abnormalities, and has since become the market leader with over 50% market share [3] - Natera has expanded its technology applications to organ health with Prospera, which non-invasively identifies organ transplant rejection using donor-derived cell-free DNA, and to oncology with Signatera, which monitors minimal residual disease and recurrence through circulating tumor DNA [3]

Summary of Natera's Conference Call Company Overview - **Company**: Natera - **Industry**: Life Sciences, Diagnostics, Oncology, Women's Health - **Core Mission**: Transforming disease management globally through proprietary technology that detects small quantities of DNA [2][3] Key Products and Market Position - **Panorama**: A cell-free fetal DNA test for chromosomal abnormalities, leading with over 50% market share [2] - **Prospera**: A test for organ transplant rejection using donor-derived cell-free DNA [2] - **Signatera**: A circulating tumor DNA test for minimal residual disease (MRD) monitoring, achieving record growth with 22,000 clinical MRD tests in Q4 [3][4] Financial Performance - **Q4 2025 Revenue**: $660 million, up 39% year-over-year, driven by strong average selling prices (ASPs) and volume growth [4] - **Free Cash Flow**: Exceeded $100 million for the year [5] - **Unit Sales**: 924,000 units in Q4, with significant growth in oncology and women's health [3][4] Innovations and Future Growth Drivers - **Fetal Focus**: A new 21-gene single-gene NIPT test aimed at severe genetic disorders, filling a gap in clinical care [5][6] - **Signatera Enhancements**: Incorporation of phased variants technology for improved sensitivity, targeting a limit of detection (LOD) down to one part per 10 million [10][11] - **AI Integration**: Development of an augmented MRD score using AI and a foundation model to enhance precision in risk assessment [12][13] Clinical Trials and Partnerships - **Clinical Trials**: Significant investments in clinical trials, particularly in breast cancer, with over $100 million allocated for evidence generation [16][17] - **STELLAR Trial**: A pivotal phase three trial in colorectal cancer, leveraging Signatera for patient enrollment [18][35] - **Partnerships**: Collaborations with NVIDIA for AI initiatives and Ultima Genomics for new product launches [22] Market Dynamics and Competitive Landscape - **Market Share**: Natera holds over 50% market share in women's health and is focused on maintaining and expanding its position through innovation and clinical evidence [25][39] - **Lymphoma Market**: Interest in expanding into lymphoma and hematologic cancers, leveraging Foresight Diagnostics' technology [27][28] Regulatory and Reimbursement Strategies - **Medicare Coverage**: Ongoing efforts to expand Multi-X coverage, with 30% of tests currently not covered under Medicare [21] - **Reimbursement Process**: Coordination with MolDX for new assay coverage, emphasizing the importance of generating data [32] Future Outlook - **2026 Goals**: Plans to complete enrollment for the FIND study in early cancer detection and launch new products incorporating advanced technologies [21][22] - **Operating Margins**: Expectation of growing into profitability as revenue matures, with a focus on maintaining operational efficiency [46][48] Conclusion Natera is positioned for significant growth through innovative product offerings, strategic partnerships, and a strong focus on clinical evidence generation. The company aims to leverage its market leadership in diagnostics to expand into new therapeutic areas while enhancing its existing product lines.

Natera, Inc. Investor presentation J.P. Morgan Healthcare Conference January 13, 2026 1 Safe harbor statement This presentation containsforward-looking statements under the meaning of the Private Securities Litigation Reform Act of 1995. Allstatements other than statements of historical facts contained in this presentation, including statements regarding our market opportunity, our anticipated products and launch schedules, our reimbursement coverage and our product costs, our commercial and strategic partn ...

Core Insights - Exelixis, Inc. (EXEL) has announced a collaboration with Natera (NTRA) for the STELLAR-316 study, a phase III trial evaluating zanzalintinib in patients with resected stage II/III colorectal cancer (CRC) [1][3] - Following the announcement, Exelixis' stock rose by 6% on January 7, and the shares have increased by 33.9% over the past year, outperforming the industry gain of 17.2% [1] Study Details - The STELLAR-316 study is set to begin in mid-2026 and will assess zanzalintinib, a novel oral kinase inhibitor, both alone and in combination with an immune checkpoint inhibitor [3][7] - Eligible patients for the trial are those with molecular residual disease (MRD)-positive CRC, as determined by Natera's Signatera test, after definitive therapy [3][4] - The primary endpoint of the study is disease-free survival, with a secondary endpoint focusing on the clearance of circulating tumor DNA [4][7] Zanzalintinib Development - Zanzalintinib is also being evaluated for advanced solid tumors, including CRC, kidney cancer, and neuroendocrine tumors [8] - Exelixis has submitted a new drug application (NDA) to the FDA for zanzalintinib in combination with Roche's Tecentriq for previously treated metastatic colorectal cancer, supported by positive results from the STELLAR-303 study [9][10] - The STELLAR-303 trial demonstrated a statistically significant reduction in the risk of death compared to Stivarga, with consistent overall survival benefits across various subgroups [10][11] Future Plans - Exelixis is planning additional pivotal trials for zanzalintinib, including studies in post-chemotherapy adjuvant CRC settings and high-grade recurrent meningiomas [12][13] - The company aims to expand its oncology portfolio beyond its lead drug, Cabometyx, which has recently received label expansion for treating neuroendocrine tumors [14]

Core Insights - Natera, Inc. announced new data from the ALTAIR trial will be presented at the 2026 ASCO GI Symposium, highlighting advancements in precision medicine and cell-free DNA technology [1] Group 1: ALTAIR Trial Findings - The ALTAIR trial, a randomized, double-blind, phase III study, demonstrated a statistically significant disease-free survival (DFS) benefit for Trifluridine/Tipiracil (FTD/TPI) compared to placebo in Signatera-positive patients with stage I-IV colorectal cancer, with median DFS of 9.23 months versus 5.55 months (HR: 0.75, 95% CI: 0.55-0.98; P=0.0406) [2] - This analysis represents a significant update from previous ALTAIR findings, which did not show a statistically significant DFS improvement in the full study population [2] Group 2: Prognostic Studies - Natera will present a large-scale study on Signatera velocity as a prognostic marker for relapse risk, indicating that CRC patients with Signatera levels doubling in one month or less had approximately 40% shorter recurrence-free survival compared to those with slower doubling times [3] - The prognostic association of circulating tumor DNA (ctDNA) increase and recurrence risk was significant for both patients who received adjuvant chemotherapy and those who did not [3] Group 3: Company Positioning and Future Directions - Natera's extensive evidence across various tumor types positions the company to define ctDNA dynamics, translating them into actionable clinical insights for cancer management [4] - The company aims to integrate personalized genetic testing and diagnostics into standard care, supported by over 325 peer-reviewed publications demonstrating excellent performance [10]