AUSTIN, Texas--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA (cfDNA) and genetic testing, today announced the launch of a new cfDNA-based fetal RhD test. This comes at a critical time for the healthcare industry, helping physicians navigate patient care given nationwide shortages of Rho(D) immune globulin therapy (RhIg)..

德克萨斯州奥斯汀--（商业新闻短讯）--无细胞DNA（cfDNA）和基因检测领域的全球领导者Natera，Inc.（纳斯达克：NTRA）今天宣布推出一种新的基于cfDNA的胎儿RhD检测。这正值医疗保健行业的关键时刻，帮助医生在全国范围内缺乏Rho（D）免疫球蛋白疗法（RhIg）的情况下管理患者护理。。

Natera’s test can be performed as early as nine weeks gestation and determines fetal RhD status from the blood of a pregnant patient, including complex pseudogene and RhD-CE-D hybrid variants. The vast majority of other NIPT laboratories do not offer fetal RhD assessment, which makes it a key differentiator in addition to Natera’s core SNP-based technology..

Natera的测试最早可以在妊娠9周时进行，并从孕妇的血液中确定胎儿RhD的状态，包括复杂的假基因和RhD-CE-D杂交变体。绝大多数其他NIPT实验室不提供胎儿RhD评估，这使得它成为Natera基于SNP的核心技术之外的关键区别。。

Up to 15 percent of pregnant patients are RhD-negative1. When the maternal blood type is RhD-negative and the fetal blood type is RhD-positive, antibodies can develop (alloimmunization) that can lead to hemolytic disease of the fetus and newborn. Historically, this risk is well managed by giving RhIg to all RhD-negative patients despite the fact that only 60%2 of them carry an RhD-positive fetus.

高达15%的孕妇RhD阴性1。当母体血型为RhD阴性而胎儿血型为RhD阳性时，会产生抗体（同种免疫），从而导致胎儿和新生儿的溶血病。从历史上看，尽管其中只有60%的患者携带RhD阳性胎儿，但通过向所有RhD阴性患者提供RhIg可以很好地控制这种风险。

In response to the nationwide shortage of RhIg, the American College of Obstetricians and Gynecologists (ACOG) recently stated that using NIPT to “prioritize use of RhIg and conserve RhIg supply is a reasonable consideration.”.

为了应对全国范围内RhIg的短缺，美国妇产科学会（ACOG）最近表示，使用NIPT“优先使用RhIg并保存RhIg供应是一个合理的考虑因素。”。

The product launch is backed by a validation study that included fetal RhD status confirmed via newborn serology in more than 650 RhD-negative pregnancies. This is roughly 10 times more patients with confirmed outcomes than validation studies from other laboratories. Natera’s test performed with 100% sensitivity and greater than 99% specificity..

该产品的推出得到了一项验证研究的支持，该研究包括通过新生儿血清学证实的650多例RhD阴性妊娠的胎儿RhD状态。与其他实验室的验证研究相比，这大约是确诊结果患者的10倍。Natera的测试具有100%的敏感性和99%以上的特异性。。

Natera’s study was accepted as a late-breaking abstract for ACOG’s Annual Clinical & Scientific Meeting, and the results will be presented at the meeting on May 18, 2024. This clinical validation is Natera’s second study on fetal RhD. In 2023, Natera presented data at the American Society of Human Genetics (ASHG) Annual Meeting on 180 RhD-negative pregnancies, which showed similar performance..

纳特拉的研究被公认为ACOG年度临床与科学会议的最新摘要，研究结果将在2024年5月18日的会议上公布。这项临床验证是Natera对胎儿RhD的第二项研究。2023年，纳特拉在美国人类遗传学学会（ASHG）年会上提交了180例RhD阴性妊娠的数据，表现相似。。

“Having an accurate, well-validated fetal RhD test is critical given the current shortage of RhIg and the tremendous complications alloimmunization can cause to a baby’s health in a subsequent pregnancy,” said Victor Klein, M.D., M.B.A., System Director of Quality & Patient Safety for Obstetrics & Gynecology at Northwell Health.

Northwell health妇产科质量与患者安全系统总监、医学博士维克多·克莱因（Victor Klein）表示：“鉴于目前缺乏RhIg以及同种免疫可能在随后的妊娠中对婴儿健康造成的巨大并发症，进行准确、经过充分验证的胎儿RhD检测至关重要。”。

“It is especially important that clinicians have access to these tools right now to help determine which patients are most in need of RhIg.”.

“临床医生现在可以使用这些工具来帮助确定哪些患者最需要RhIg，这一点尤为重要。”。

“We are proud to offer this highly validated fetal RhD test at a time of critical need in the prenatal community,” said Jeffrey Meltzer, M.D., Senior Medical Director, Women’s Health at Natera.

Natera妇女健康高级医学主任JeffreyMeltzer医学博士说：“在产前社区急需的时候，我们很自豪能提供这种经过高度验证的胎儿RhD检测。”。

The RhD test is a new offering within Natera’s women’s health suite of products, which also includes Panorama, the No. 1 ordered noninvasive prenatal test in the U.S.

RhD测试是Natera女性健康系列产品中的一项新产品，其中还包括Panorama，这是美国排名第一的无创产前检查。

About Panorama

关于全景

Panorama screens for severe genetic disorders as early as nine weeks into pregnancy. The test uses a unique single-nucleotide polymorphism (SNP)-based technology to analyze fetal (placental) DNA obtained through a maternal blood draw. It is the only commercially available NIPT that differentiates between maternal and fetal DNA to assess the risk of aneuploidies.

Panorama最早在怀孕九周时就筛查出严重的遗传疾病。该测试使用独特的基于单核苷酸多态性（SNP）的技术来分析通过母体抽血获得的胎儿（胎盘）DNA。它是唯一可用于区分母体和胎儿DNA以评估非整倍体风险的市售NIPT。

Panorama has been the subject of more than 40 peer-reviewed publications of over 2 million patients. Panorama has been developed and its performance characteristics determined by Natera, the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the US Food and Drug Administration (FDA).

Panorama是200多万患者的40多篇同行评审出版物的主题。Panorama已经开发出来，其性能特征由进行测试的CLIA认证实验室Natera确定。该测试尚未获得美国食品和药物管理局（FDA）的批准或批准。

CAP accredited, ISO 13485 certified, and CLIA certified..

CAP认证、ISO 13485认证和CLIA认证。。

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 200 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200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, or our expectations 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，或我们对我们的测试和产品对患者，提供者和付款人的益处的期望。

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

Zipursky A, Paul VK. The global burden of Rh disease. Arch Dis Child Fetal Neonatal Ed 2011;96:F84–5. (Level III)

Zipursky A，Paul VK。Rh疾病的全球负担。Arch Dis儿童胎儿新生儿Ed 2011；96：F84–5。（三级）

ACOG. Practice Bulletin 181: Prevention of Rh D Alloimmunization. 2017. https://journals.lww.com/greenjournal/fulltext/2017/08000/practice_bulletin_no__181_summary__prevention_of.48.aspx

ACOG公司。实践公告181：预防Rh D同种免疫。2017https://journals.lww.com/greenjournal/fulltext/2017/08000/practice_bulletin_no__181_summary__prevention_of.48.aspx