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Natera, Inc.

Natera公司。

(NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, today commented on recent updates by the NCCN on circulating tumor DNA (ctDNA) molecular residual disease (MRD) testing in the Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for colon cancer, rectal cancer, and merkel cell carcinoma (MCC)..

（纳斯达克：NTRA），无细胞DNA和基因检测的全球领导者，今天评论了NCCN最近在《肿瘤学临床实践指南》（NCCN Guidelines®）中对结肠癌、直肠癌和默克尔细胞癌（MCC）循环肿瘤DNA（ctDNA）分子残留病（MRD）检测的最新更新。。

In its updated guidelines for colon cancer

在其最新的结肠癌指南中

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and for rectal cancer

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, NCCN now includes ctDNA as a high risk factor for recurrence in the adjuvant setting, recognizing its prognostic value. This represents a significant step forward as it’s the first time the committee has formally recognized ctDNA as being prognostic. The guidelines remain cautious about ctDNA for surveillance, as expected.

，NCCN现在将ctDNA作为辅助治疗复发的高危因素，认识到其预后价值。这是向前迈出的重要一步，因为这是委员会首次正式承认ctDNA具有预后作用。正如预期的那样，指南对ctDNA的监测仍持谨慎态度。

The NCCN finalized these updates before data from the phase III CALGB (Alliance) / SWOG 80702 study were presented at ASCO GI in January, supporting the predictive nature of Signatera in the adjuvant setting..

NCCN在1月ASCO GI上提交第三阶段CALGB（联盟）/SWOG 80702研究的数据之前完成了这些更新，支持了Signatera在佐剂环境中的预测性质。。

For MCC, the updated NCCN guidelines state that “

对于MCC，最新的NCCN指南指出“

ctDNA can assess disease burden in both virus-positive and virus-negative MCC and typically becomes positive prior to or at the time of a clinically evident recurrence. For surveillance, this test is often obtained every 3 months.”

ctDNA可以评估病毒阳性和病毒阴性MCC的疾病负担，通常在临床明显复发之前或之时呈阳性。为了进行监督，通常每3个月进行一次测试。”

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In addition, the guideline specifically references a Signatera publication with data from a prospective multicenter study published in 2024 in the

此外，该指南特别引用了Signatera出版物中2024年发表的一项前瞻性多中心研究的数据

Journal of Clinical Oncology

临床肿瘤学杂志

(JCO). The study demonstrated excellent performance of Signatera, with 95% detection at time of enrollment and 20x higher risk of recurrence among patients who were persistently Signatera positive. Natera believes this positive update on MCC can set a precedent for the important role of ctDNA testing across other indications..

（JCO）。该研究表明Signatera表现出色，入选时检出率为95%，持续Signatera阳性患者的复发风险高20倍。纳特拉认为，MCC的这一积极更新可以为ctDNA检测在其他适应症中的重要作用开创先例。。

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Signatera tumor-informed ctDNA testing is a highly accurate and prognostic biomarker for surveillance of high- and low-risk patients with MCC to help determine imaging frequency,” said Lisa Zaba, M.D., Ph.D., associate professor of dermatology, director of the MCC multi-disciplinary clinic and member of the supportive oncodermatology group at the Stanford Cancer Center..

Signatera肿瘤知情ctDNA检测是一种高度准确和预后的生物标志物，可用于监测MCC高危和低危患者，以帮助确定成像频率，”Lisa Zaba，医学博士，皮肤病学副教授，MCC多学科诊所主任，斯坦福癌症中心肿瘤皮肤病支持小组成员说道。。

MCC is a rare skin cancer (~3,000 patients diagnosed annually) which disproportionately affects the elderly with most patients diagnosed above age 70.

MCC是一种罕见的皮肤癌（每年诊断约3000例），对老年人的影响不成比例，大多数患者被诊断为70岁以上。

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MCC has high mortality and a recurrence rate of 40% within 5 years.

MCC死亡率高，5年内复发率为40%。

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These guideline changes came faster than expected given the typical timelines to be included,” said Alexey Aleshin, M.D., corporate chief medical officer and general manager of oncology for Natera. “

考虑到典型的时间表，这些指南的变化比预期的要快，”纳特拉公司首席医疗官兼肿瘤学总经理Alexey Aleshin医学博士说。“”

The inclusion of ctDNA testing in NCCN guidelines for these histologies is another step toward more personalized care for patients with cancer.”

将ctDNA检测纳入NCCN的这些组织学指南是为癌症患者提供更个性化护理的又一步。”

About Signatera

关于Signatera

Signatera

签名

is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard-of-care tools, and help optimize treatment decisions.

是一种针对先前诊断为癌症的患者的个性化，肿瘤信息，分子残留疾病检测。Signatera为每个人定制，使用循环肿瘤DNA来检测和量化体内残留的癌症，比标准护理工具更早地识别复发，并帮助优化治疗决策。

The test is available for clinical and research use and is covered by Medicare for patients with colorectal cancer, breast cancer, ovarian cancer, and muscle-invasive bladder cancer, as well as for immunotherapy monitoring of any solid tumor. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in over 100 peer-reviewed papers..

该测试可用于临床和研究用途，并由Medicare覆盖，用于结直肠癌，乳腺癌，卵巢癌和肌肉浸润性膀胱癌患者，以及任何实体瘤的免疫治疗监测。Signatera已在多种癌症类型和适应症中得到临床验证，并在100多篇同行评审论文中发表了证据。。

About Natera

关于Natera

Natera™ is a global leader in cell-free DNA and genetic testing, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard of care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives.

Natera™是无细胞DNA和基因检测领域的全球领导者，致力于肿瘤学、女性健康和器官健康。我们的目标是将个性化基因检测和诊断作为护理标准的一部分，以保护健康，并为更早，更有针对性的干预措施提供信息，从而帮助人们获得更长，更健康的生活。

Natera’s tests are validated by more than 250 peer-reviewed publications that demonstrate high accuracy. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California. For more information, visit .

Natera的测试得到了250多份同行评审出版物的验证，这些出版物具有很高的准确性。Natera在德克萨斯州的奥斯汀和加利福尼亚州的圣卡洛斯运营着根据临床实验室改进修正案（CLIA）认证的ISO 13485认证和CAP认证的实验室。有关更多信息，请访问。

www.natera.com

www.natera.com

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Forward-Looking Statements

前瞻性声明

All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements.

除本新闻稿中包含的历史事实声明外，所有声明均为前瞻性声明，并不表示Natera的计划、估计或预期将得以实现。截至本新闻稿发布之日，这些前瞻性声明代表了Natera的期望，Natera不承担更新前瞻性声明的任何义务。

These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy, and performance of our tests, coverage and reimbursement determinations from third-party payers, or our expectations or of the benefits of our tests and product offerings to patients, providers, and payers.

这些前瞻性陈述受到已知和未知风险和不确定性的影响，这些风险和不确定性可能会导致实际结果产生重大差异，包括临床或其他研究的结果是否会支持我们产品的使用，此类研究结果的影响，我们对测试的可靠性，准确性和性能的期望，第三方付款人的覆盖率和报销决定，或者我们对患者，提供者和付款人的测试和产品的期望或益处。

Additional risks and uncertainties are discussed in greater detail in 'Risk Factors' in Natera’s recent filings on Forms 10-K and 10-Q, and in other filings Natera makes with the SEC from time to time. These documents are available at .

Natera最近在10-K和10-Q表格上提交的文件以及Natera不时向SEC提交的其他文件中的“风险因素”更详细地讨论了其他风险和不确定性。这些文件可在。

www.natera.com/investors

www.natera.com/投资者

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References

参考文献

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Colon Cancer Version 1.2025. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed February 7, 2025.

NCCN结肠癌临床实践指南（NCCN Guidelines®）1.2025版。©National Comprehensive Cancer Network，Inc.2025年。保留所有权利。2025年2月7日访问。

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Rectal Cancer Version 1.2025. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed February 7, 2025.

NCCN直肠癌临床实践指南（NCCN Guidelines®）1.2025版。©National Comprehensive Cancer Network，Inc.2025年。保留所有权利。2025年2月7日访问。

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Merkel Cell Carcinoma Version 1.2025. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed January 17, 2025.

默克尔细胞癌1.2025版的NCCN肿瘤学临床实践指南（NCCN Guidelines®）。©National Comprehensive Cancer Network，Inc.2025年。保留所有权利。2025年1月17日访问。

American Cancer Society. Key statistics for Merkel Cell Carcinoma.

美国癌症协会。默克尔细胞癌的关键统计数据。

https://www.cancer.org/cancer/types/merkel-cell-skin-cancer/about/key-statistics.html

https://www.cancer.org/cancer/types/merkel-cell-skin-cancer/about/key-statistics.html

McEvoy AM, Lachance K, Hippe DS, et al. Recurrence and Mortality Risk of Merkel Cell Carcinoma by Cancer Stage and Time From Diagnosis. JAMA Dermatol. 2022;158(4):382-389.

McEvoy AM，Lachance K，Hippe DS等。按癌症分期和诊断时间划分的默克尔细胞癌复发和死亡风险。JAMA皮肤病。2022年；158（4）：382-389。