Next-generation-sequencing-based homologous recombination deficiency (HRD) assay based on QIAGEN’s QIAseq xHYB technology, QIAGEN Digital Insight solutions, and Myriad’s proprietary, FDA-approved MyChoice CDx® biomarkers

基于QIAGEN的QIAseq xHYB技术、QIAGEN Digital Insight solutions和Myriad的专有、FDA批准的MyChoice CDx®生物标志物的下一代基于测序的同源重组缺陷（HRD）检测

QIAGEN to make kit-based HRD test available globally to support research and companion diagnostics development in collaboration with pharmaceutical partners enabling wider adoption and potential clinical indication expansion for MyChoice CDx

QIAGEN将在全球范围内提供基于试剂盒的HRD测试，以支持与制药合作伙伴合作的研究和伴随诊断开发，从而使MyChoice CDx获得更广泛的采用和潜在的临床适应症扩展

Project builds on recently announced master collaboration agreement between the two companies

该项目以两家公司最近宣布的主合作协议为基础

VENLO, The Netherlands and SALT LAKE CITY, May 30, 2024 (GLOBE NEWSWIRE) -- QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) and Myriad Genetics, Inc. (NASDAQ: MYGN) today announced they will develop a globally distributable kit-based test for analyzing Homologous Recombination Deficiency (HRD) status.

荷兰芬洛和盐湖城，2024年5月30日（环球新闻网）——QIAGEN（纽约证券交易所：QGEN；法兰克福主要标准：QIA）和Myriad Genetics，Inc.（纳斯达克：MYGN）今天宣布，他们将开发一种全球可分发的基于试剂盒的测试，用于分析同源重组缺陷（HRD）状态。

This next-generation sequencing (NGS) test aims to support research into personalized medicine in multiple solid tumor types, including ovarian cancer and is expected to enhance decentralized testing capacities once a regulated product is developed with pharmaceutical partners. The project builds on the recently announced master collaboration agreement between the two companies..

这项下一代测序（NGS）测试旨在支持多种实体瘤类型（包括卵巢癌）的个性化医学研究，一旦与药物合作伙伴开发出受监管的产品，预计将增强分散测试能力。该项目以两家公司最近宣布的主合作协议为基础。。

The test will be based on QIAGEN’s QIAseq xHYB technology, QIAGEN Digital Insight solutions, which creates a sample to insight HRD solutions, and Myriad’s proprietary FDA-approved MyChoice CDx, a single-site PMA-approved centralized testing service for analyzing HRD in certain tumors. MyChoice CDx assesses the HRD status by examining a tumor’s DNA repair capabilities, particularly focusing on BRCA1 and BRCA2 gene mutations and calculating a Genome Instability Score (GIS).

该测试将基于QIAGEN的QIAseq xHYB技术，QIAGEN Digital Insight solutions，它创建了一个样本到Insight HRD解决方案，以及Myriad专有的FDA批准的MyChoice CDx，这是一个单站点PMA批准的集中测试服务，用于分析某些肿瘤中的HRD。MyChoice CDx通过检查肿瘤的DNA修复能力来评估HRD状态，特别是关注BRCA1和BRCA2基因突变并计算基因组不稳定性评分（GIS）。

The GIS aids in pinpointing ovarian cancer patients who are most likely to benefit from targeted treatments, such as LYNPARZA® (olaparib) by AstraZeneca..

GIS有助于确定最有可能从靶向治疗中受益的卵巢癌患者，例如阿斯利康的LYNPARZA®（olaparib）。。

“Our partnership with Myriad Genetics underscores a shared commitment to advancing cancer diagnostics. Together, we aim to broaden the accessibility of HRD tests, allowing an increasing number of cancer patients to benefit from tailored treatments,” said Fernando Beils, Senior Vice President and head of the Molecular Diagnostics Business Area.

“我们与Myriad Genetics的合作突显了我们对推进癌症诊断的共同承诺。我们共同致力于扩大HRD检测的可及性，使越来越多的癌症患者受益于量身定制的治疗，”高级副总裁兼分子诊断业务领域负责人Fernando Beils说。

“By introducing a distributable HRD test, we anticipate a reduction in the time required for therapy decisions, a decrease in associated costs, and shorter turnaround times compared to outsourced testing, ultimately benefitting the patients.”.

“通过引入可分配的HRD测试，我们预计与外包测试相比，治疗决策所需的时间减少，相关成本降低，周转时间缩短，最终使患者受益。”。

The MyChoice CDx assay can identify 34% more tumors with HRD using the GIS score compared to other methods only using percent loss of heterozygosity (%LOH)1. Given that approximately 48% of ovarian cancer tumors exhibit HRD2, often due to specific mutations within the tumor, expanding access to this assay is vital for advancing personalized medicine and ensuring that patients receive the most appropriate treatments..

与仅使用杂合性丢失百分比（%LOH）1的其他方法相比，使用GIS评分，MyChoice CDx分析可以识别出HRD的肿瘤多34%。鉴于大约48%的卵巢癌肿瘤表现出HRD2，这通常是由于肿瘤内的特定突变所致，因此扩大这种检测方法的使用范围对于推进个性化医学和确保患者接受最合适的治疗至关重要。。

“We’re excited to share this milestone in our partnership with QIAGEN as we work collectively to advance cancer care worldwide,” said Patrick Burke, Executive Vice President of Strategy and Innovation, Myriad Genetics. “By extending the global reach and ease of access to Myriad’s gold-standard HRD-testing technology we aim to help drive wide-spread and broader clinical adoption of HRD testing.

Myriad Genetics战略与创新执行副总裁帕特里克·伯克（PatrickBurke）表示：“我们很高兴与QIAGEN分享我们合作伙伴关系中的这一里程碑，因为我们共同努力推进全球癌症治疗。”。“通过扩大Myriad黄金标准人力资源开发测试技术的全球范围和易用性，我们旨在帮助推动人力资源开发测试的广泛推广和更广泛的临床应用。

This milestone demonstrates what the QIAGEN and Myriad partnership is uniquely able to deliver to pharmaceutical partners – propriety content, cutting edge assay platforms, clinical trial execution, and world-wide CDx product distribution.”.

这一里程碑证明了QIAGEN和Myriad partnership能够为制药合作伙伴提供独特的服务-适当的内容，尖端的检测平台，临床试验执行以及全球CDx产品分销。”。

QIAGEN will manage the development and distribution of the kit-based HRD test outside of the United States. The IP license grants QIAGEN the capability to collaborate with pharmaceutical partners to create an IVD-validated test, intended for use as a companion diagnostic outside of the United States.

QIAGEN将管理美国境外基于试剂盒的人力资源开发测试的开发和分发。IP许可证授予QIAGEN与制药合作伙伴合作创建IVD验证测试的能力，该测试旨在用作美国以外的伴随诊断。

The combined regulatory expertise of QIAGEN and Myriad enables seamless compliance and integration in clinical and companion diagnostic applications..

QIAGEN和Myriad的监管专业知识相结合，可以在临床和伴随诊断应用中实现无缝合规和集成。。

QIAGEN’s QIAseq panels enable efficient and accurate NGS library preparation. Over 4 million samples have been processed with QIAseq panels for cancer testing applications.3

QIAGEN的QIAseq面板可实现高效准确的NGS文库制备。QIAseq面板处理了400多万个样本，用于癌症检测应用。3

QIAGEN has master collaboration agreements to develop and commercialize companion diagnostics with more than 30 global pharma and biotech companies – a deep pipeline that helps advance precision medicine in diverse disease indications, tailoring a patient’s treatment to the genetic profile identified by companion diagnostics testing.

QIAGEN与30多家全球制药和生物技术公司签订了主要合作协议，以开发和商业化伴随诊断，这是一条深入的管道，有助于在各种疾病适应症中推进精准医学，根据伴随诊断测试确定的基因特征调整患者的治疗。

Myriad has provided testing support for hundreds of clinical trials, has obtained 10 companion diagnostic approvals from the FDA and PMDA, and anticipates that the QIAGEN partnership will drive the expansion of the Myriad’s oncology products portfolio..

Myriad为数百项临床试验提供了测试支持，已获得FDA和PMDA的10项伴随诊断批准，并预计QIAGEN合作伙伴关系将推动Myriad肿瘤学产品组合的扩展。。

About Myriad Genetics

关于无数遗传学

Myriad Genetics is a leading genetic testing and precision medicine company dedicated to advancing health and well-being for all. Myriad develops and offers genetic tests that help assess the risk of developing disease or disease progression and guide treatment decisions across medical specialties where genetic insights can significantly improve patient care and lower healthcare costs.

Myriad Genetics是一家领先的基因检测和精准医学公司，致力于促进所有人的健康和福祉。Myriad开发并提供基因检测，帮助评估疾病发展或疾病进展的风险，并指导跨医学专业的治疗决策，在这些专业中，遗传见解可以显着改善患者护理并降低医疗保健成本。

For more information, visit www.myriad.com..

有关更多信息，请访问www.myriad.com。。

About QIAGEN

关于QIAGEN

QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials.

QIAGEN N.V.是一家总部位于荷兰的控股公司，是全球领先的样本到见解解决方案提供商，该解决方案使客户能够从包含生命构建模块的样本中获得有价值的分子见解。我们的样品技术从血液、组织和其他材料中分离和处理DNA、RNA和蛋白质。

Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics).

分析技术使这些生物分子可见并准备进行分析。生物信息学软件和知识库解释数据以报告相关的可行见解。自动化解决方案以无缝且经济高效的工作流将这些功能结合在一起。QIAGEN在分子诊断（人类医疗保健）和生命科学（学术界，制药研发和工业应用，主要是法医学）方面为全球50多万客户提供解决方案。

As of March 31, 2024, QIAGEN employed approximately 5,900 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com..

截至2024年3月31日，QIAGEN在全球35多个地点雇用了约5900人。有关更多信息，请访问http://www.qiagen.com..

Forward-Looking Statement

前瞻性声明

Certain statements contained in this press release may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended, including statements relating to the development of a globally distributable kit-based test for analyzing HRD status and the anticipated benefits of the Myriad and QIAGEN partnership, including that the partnership may drive the expansion of Myriad’s oncology products portfolio and enable potential clinical indication expansion for MyChoice CDx.

本新闻稿中的某些声明可能被视为1933年《美国证券法》第27A节（经修订）和1934年《美国证券交易法》第21E节（经修订）所指的前瞻性声明，包括与开发全球可分发的基于试剂盒的测试以分析人力资源开发状况以及Myriad和QIAGEN合伙企业的预期收益有关的声明，包括该合伙企业可能会推动Myriad肿瘤产品组合的扩展，并使MyChoice CDx的潜在临床适应症扩展成为可能。

To the extent that any of the statements contained herein relating to QIAGEN's products, timing for launch and development, marketing and/or regulatory approvals, financial and operational outlook, growth and expansion, collaborations, markets, strategy or operating results, including without limitation its expected adjusted net sales and adjusted diluted earnings results, are forward-looking, such statements are based on current expectations and assumptions that involve a number of uncertainties and risks.

如果本文中包含的与QIAGEN产品、发布和开发时间、营销和/或监管批准、财务和运营前景、增长和扩张、合作、市场、战略或运营结果（包括但不限于其预期的调整后净销售额和调整后的稀释收益结果）有关的任何报表都是前瞻性的，则此类报表基于当前的预期和假设，涉及许多不确定性和风险。

Such uncertainties and risks include, but are not limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations, regulatory processes and dependence on logistics), variability of operating results and allocations between customer classes, the commercial development of markets for our products to customers in academia, pharma, applied testing and molecular diagnostics; changing relationships with customers, suppliers and strategic partners; competition; rapid or unexpected changes in technologies; fluctuations in demand for QIAGEN's products (including fluctuations due to general economic conditions, the level a.

此类不确定性和风险包括但不限于与增长管理和国际运营相关的风险（包括货币波动的影响、监管流程和对物流的依赖）、经营成果的可变性和客户类别之间的分配、我们的产品在学术界、制药、应用测试和分子诊断领域的客户市场的商业开发；改变与客户、供应商和战略合作伙伴的关系；竞争；技术的快速或意外变化；QIAGEN产品的需求波动（包括一般经济条件引起的波动，a级）。

Any “forward-looking statements” relating to Myriad or the development of a globally distributable kit-based test for analyzing HRD status are Myriad's management’s expectations of future events as of the date hereof and are subject to known and unknown risks and uncertainties that could cause actual results, conditions, and events to differ materially and adversely from those anticipated.

与Myriad相关的任何“前瞻性声明”或用于分析人力资源开发状况的全球可分发工具包测试的开发都是Myriad管理层对截至本协议日期的未来事件的预期，并且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导致实际结果、条件和事件与预期存在重大不利差异。

Such factors include those risks described in Myriad’s filings with the U.S. Securities and Exchange Commission, including Myriad’s Annual Report on Form 10-K filed on February 28, 2024, as well as any updates to those risk factors filed from time to time Myriad’s Quarterly Reports on Form 10-Q or Current Reports on Form 8-K.

这些因素包括Myriad向美国证券交易委员会提交的文件中描述的风险，包括Myriad于2024年2月28日提交的10-K表格年度报告，以及Myriad不时提交的10-Q表格季度报告或8-K表格当前报告中对这些风险因素的任何更新。

Myriad is not under any obligation, and it expressly disclaims any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise except as required by law..

Myriad没有任何义务，也明确否认有义务更新或更改任何前瞻性声明，无论是由于新信息、未来事件还是其他原因，除非法律要求。。

Contacts QIAGEN:

联系人QIAGEN：

Investor Relations

投资者关系

Public Relations

公共关系

John Gilardi

约翰·吉拉迪

Domenica Martorana

Martorana周日

+49 2103 29 11711

+49 2103 29 11711

+49 2103 29 11244

+49 2103 29 11244

Thomas Theuringer

Thomas Theuringer

Lisa Mannagottera

Lisa Mannagottera

+49 2103 29 11826

+49 2103 29 11826

+49 2103 29 14181

+49 2103 29 14181

e-mail:ir@QIAGEN.com

电子邮件ir@QIAGEN.com

e-mail:pr@QIAGEN.com

电子邮件pr@QIAGEN.com

Contacts MYRIAD:

联系人无数：

Investor Contact

投资者联系人

Media Contact

媒体联系人

Matt Scalo

Matt Scalo

+1-801-584-3532

+1-801-584-3532

Glenn Farrell

格伦·法雷尔

+1-385-318-3718

+1-385-318-3718

IR@myriad.com

IR@myriad.com

PR@myriad.com

PR@myriad.com

1 Timms, et al. JClinOnc 2020 38:15_suppl, 1586-1586.

1 Timms等人，JClinonc 2020 38:15，1586-1586。

2 Moore et. al, Lancet Oncol 2019

2 Moore等人，Lancet Oncol 2019

3 QIAseq products are intended for molecular biology applications. These products are not intended for the diagnosis, prevention, or treatment of a disease.

3 QIAseq产品用于分子生物学应用。这些产品不用于疾病的诊断、预防或治疗。