Expanded EBLIS study with up to 12 years of clinical follow-up across all subtypes of breast cancer

扩大了EBLIS研究，对所有乳腺癌亚型进行了长达12年的临床随访

AUSTIN, Texas--(BUSINESS WIRE)-- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, today announced a new publication in JCO Precision Oncology reporting on the ability of its personalized and tumor-informed molecular residual disease (MRD) test, Signatera, to detect recurrence early in patients with early-stage breast cancer.

德克萨斯州奥斯汀——（商业新闻短讯）——无细胞DNA和基因检测领域的全球领导者Natera，Inc.（纳斯达克：NTRA）今天在JCO Precision Oncology上发布了一份新出版物，报告了其个性化和肿瘤信息分子残留病（MRD）检测Signatera的能力，以早期检测早期乳腺癌患者的复发。

The full study can be found here..

完整的研究可以在这里找到。。

The study evaluated a total of 1,136 prospectively collected and banked plasma samples from 156 early-stage breast cancer patients enrolled in the multi-site Exploratory Breast Lead Interval Study (EBLIS). Patients were followed for up to 12 years after surgery and adjuvant chemotherapy, with blood samples collected semi-annually and then analyzed using Signatera.

该研究评估了参加多部位探索性乳腺癌导联间隔研究（EBLIS）的156名早期乳腺癌患者的1136份前瞻性收集和储存的血浆样本。手术和辅助化疗后对患者进行长达12年的随访，每半年采集一次血样，然后使用Signatera进行分析。

Key findings include:.

主要发现包括：。

Signatera detected relapse up to 38 months earlier than imaging (median lead time 10.5 months), with an overall sensitivity of 88.2% (30/34)

Signatera比成像早38个月发现复发（中位前置时间10.5个月），总体敏感性为88.2%（30/34）

Relapse-free survival (RFS) and overall survival (OS) were significantly worse in patients who were ctDNA-positive, regardless of hormone receptor and HER2 subtype (HR 52.98 and 53.69, respectively). In a multivariate analysis, ctDNA status was the most significant factor associated with RFS and OS..

无论激素受体和HER2亚型如何，ctDNA阳性患者的无复发生存期（RFS）和总生存期（OS）均显着较差（分别为HR 52.98和53.69）。在多变量分析中，ctDNA状态是与RFS和OS相关的最重要因素。。

“The EBLIS study shows that post-operative monitoring with Signatera can detect recurrence much earlier than scans, opening up a critical window for early therapeutic intervention and clinical trials focused on molecular recurrence,” said Charles Coombes, MD, PhD professor of medical oncology at the Imperial College London and principal investigator of the EBLIS study.

“EBLIS研究表明，使用Signatera进行术后监测可以比扫描更早地发现复发，为早期治疗干预和专注于分子复发的临床试验打开了一个关键窗口，”伦敦帝国理工学院医学肿瘤学博士教授兼EBLIS研究首席研究员Charles Coombes说。

“Additionally, we demonstrate the value of longitudinal testing in providing reassurance to breast cancer patients, as those who test serially ctDNA-negative show better clinical outcomes.”.

“此外，我们证明了纵向检测在为乳腺癌患者提供保证方面的价值，因为那些连续检测ctDNA阴性的患者显示出更好的临床结果。”。

Breast cancer is the most common cancer in women in the U.S. and the second leading cause of cancer death in women.1 The current standard of care for most patients with early-stage breast cancer consists of surgery and adjuvant chemotherapy and/or endocrine therapy.2,3 However, patients with early-stage breast cancer experience a rate of local recurrence of roughly 15% and distant metastases of 21% after primary treatment.4.

乳腺癌是美国女性中最常见的癌症，也是女性癌症死亡的第二大原因[1]。目前大多数早期乳腺癌患者的护理标准包括手术和辅助化疗和/或内分泌治疗[2,3]。然而，早期乳腺癌患者在初次治疗后局部复发率约为15%，远处转移率为21%。

“This expanded EBLIS study reinforces the importance of early recurrence detection with Signatera and the potential to improve care management for patients with breast cancer,” said Minetta Liu, MD, chief medical officer of oncology. “The findings also bolster the evidence for long-term monitoring of high-risk breast cancer patients, who often face late recurrences.”.

肿瘤学首席医学官Minetta Liu医学博士说：“这项扩展的EBLIS研究强化了Signatera早期复发检测的重要性，以及改善乳腺癌患者护理管理的潜力。”。“这些发现也为长期监测经常面临晚期复发的高危乳腺癌患者提供了证据。”。

About Signatera

关于Signatera

Signatera 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.

Signatera是一种针对先前诊断为癌症的患者的个性化，肿瘤信息，分子残留疾病测试。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 more than 60 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60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 supported by more than 200 peer-reviewed publications that demonstrate excellent performance. 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 www.natera.com..

Natera的测试得到了200多份同行评审出版物的支持，这些出版物表现出优异的性能。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。。

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, 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，或我们的测试和产品对患者，提供者和付款人的益处。

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 www.natera.com/investors and www.sec.gov..

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和www.sec.gov上查阅。。

References

参考文献

American Cancer Society. Cancer Facts and Figures 2024. Atlanta: American Cancer Society; 2024.

美国癌症协会。2024年癌症事实和数字。亚特兰大：美国癌症协会；2024

Gradishar WJ, Moran MS, Abraham J, et al. NCCN Guidelines® Insights: Breast Cancer, Version 4.2023. J Natl Compr Canc Netw. 2023;21(6):594-608.

Gradishar WJ，Moran MS，Abraham J等人。NCCN指南®见解：乳腺癌，版本4.2023。J国家压缩机网络。2023年；21（6）：594-608。

Senkus E, Kyriakides S, Ohno S et al. Primary breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 2015;26 Suppl 5: v8-30.

Senkus E，Kyriakides S，Ohno S等。原发性乳腺癌：ESMO诊断，治疗和随访的临床实践指南。Ann Oncol 2015；26供油5:v8-30。

Lyngholm CD, Laurberg T, Alsner J, Damsgaard TE, Overgaard J, Christiansen PM. Failure pattern and survival after breast conserving therapy. Long-term results of the Danish Breast Cancer Group (DBCG) 89 TM cohort. Acta Oncol. 2016;55(8):983-92.

Lyngholm CD，Laurberg T，Alsner J，Damsgaard TE，Overgaard J，Christiansen PM。保乳治疗后的失败模式和生存率。丹麦乳腺癌组（DBCG）89 TM队列的长期结果。肿瘤学学报。2016年；55（8）：983-92。

View source version on businesswire.com: https://www.businesswire.com/news/home/20240503118111/en/

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Contacts

联系人

Investor Relations: Mike Brophy, CFO, Natera, Inc., 510-826-2350, investor@natera.com

投资者关系：Mike Brophy，首席财务官，Natera，Inc.，510-826-2350，investor@natera.com

Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., pr@natera.com

媒体：LesleyBogdanow，Natera公司企业传播副总裁。，pr@natera.com

Source: Natera, Inc.

资料来源：Natera公司。

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在线查看此新闻稿，网址为：

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