AUSTIN, Texas--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced a new study published in Molecular Oncology comparing the performance of mean tumor molecules per milliliter (MTM/mL) against mean variant allele frequency (mVAF) for measuring circulating tumor DNA (ctDNA), using Signatera™, Natera’s personalized and tumor-informed molecular residual disease (MRD) test.

德克萨斯州奥斯汀——（商业新闻短讯）——Natera公司（纳斯达克：NTRA）是无细胞DNA检测的全球领导者，今天宣布了一项发表在《分子肿瘤学》上的新研究，该研究比较了每毫升平均肿瘤分子（MTM/mL）与平均变异等位基因频率（mVAF）的性能，以使用Signatera测量循环肿瘤DNA（ctDNA）™,Natera的个性化和肿瘤信息分子残留病（MRD）测试。

The full study can be found here..

完整的研究可以在这里找到。。

To date, mVAF and MTM/mL are the two main metrics that have been used to quantify ctDNA levels in the blood. Unlike mVAF, which is a fraction that can be confounded by changes in total background cfDNA, MTM/mL takes into account total cfDNA as well as plasma volume. The premise is that MTM/mL is therefore more representative of a patient’s true disease burden, a hypothesis that was validated in this study..

迄今为止，mVAF和MTM/mL是用于量化血液中ctDNA水平的两个主要指标。与mVAF不同，mVAF是一个可以被总背景cfDNA变化混淆的分数，MTM/mL考虑了总cfDNA和血浆体积。前提是MTM/mL因此更能代表患者的真实疾病负担，这一假设在本研究中得到了验证。。

The study analyzed ctDNA data generated in 55,183 ctDNA-positive samples from 23,543 patients who underwent testing with Signatera for various cancer diagnoses, and it reported the correlation between MTM/mL and mVAF, as well as the correlations of each with patient outcomes.

该研究分析了来自23543名接受Signatera检测的各种癌症诊断患者的55183份ctDNA阳性样本中产生的ctDNA数据，并报告了MTM/mL和mVAF之间的相关性，以及每种与患者预后的相关性。

Key findings include:

主要调查结果包括：

Among the 18,426 patients with longitudinal ctDNA measurements, 13.3% had discordant ctDNA trajectories (increase/decrease) when calculated using MTM/mL versus mVAF.

在18426例纵向ctDNA测量患者中，当使用MTM/mL与mVAF计算时，13.3%的患者的ctDNA轨迹不一致（增加/减少）。

In patients with stage IV disease receiving immunotherapy (N=51), ctDNA dynamics measured in MTM/mL were more predictive of therapy response than those measured in mVAF, with a hazard ratio (HR) nearly 2x higher (MTM/mL HR 16, p<0.0001; mVAF HR 8.8, p<0.0001).

在接受免疫治疗的IV期疾病患者（N=51）中，以MTM/mL测量的ctDNA动力学比以mVAF测量的ctDNA动力学更能预测治疗反应，风险比（HR）高近2倍（MTM/mL HR 16，p<0.0001；mVAF HR 8.8，p<0.0001）。

In a case study of a patient with metastatic triple-negative breast cancer, disease progression during systemic therapy was reflected in increasing MTM/mL values, while mVAF levels remained stable.

在转移性三阴性乳腺癌患者的病例研究中，全身治疗期间的疾病进展反映在MTM/mL值增加，而mVAF水平保持稳定。

“We are pleased to see the publication of these important findings, in which MTM/mL provided a more accurate measure of ctDNA than mVAF, particularly for patients undergoing active therapy which can impact the levels of background cfDNA,” said Minetta Liu, M.D., chief medical officer of oncology at Natera.

“我们很高兴看到这些重要发现的公布，其中MTM/mL比mVAF提供了更准确的ctDNA测量，特别是对于接受积极治疗的患者，这可能会影响背景cfDNA的水平，”Natera肿瘤首席医学官Minetta Liu医学博士说。

“Clinicians need tools to enable reliable predictions of therapy response and clinical outcomes. As the only MRD test that uses MTM/mL, this study supports the utility of Signatera for ctDNA quantification, to measure treatment response at critical time points and inform decisions on how patients are managed.”.

“临床医生需要工具来可靠地预测治疗反应和临床结果。作为唯一使用MTM/mL的MRD测试，这项研究支持Signatera用于ctDNA定量的实用性，以测量关键时间点的治疗反应，并告知如何管理患者的决定。”。

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 (stage IIb and higher) 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 50 peer-reviewed papers..

该测试可用于临床和研究用途，适用于结直肠癌，乳腺癌（IIb期及以上）和肌肉浸润性膀胱癌患者的医疗保险，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50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 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.

纳特拉™是无细胞DNA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。我们的目标是使个性化的基因检测和诊断成为保护健康的护理标准的一部分，并为更早，更有针对性的干预措施提供信息，以帮助人们获得更长，更健康的生活。

Natera’s tests are validated by more than 180 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 www.natera.com..

Natera的测试得到了180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在德克萨斯州奥斯汀和加利福尼亚州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提供给患者、提供者和付款人的好处。

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。。