Boston, US, and Rolle, Switzerland, September 5, 2024 – SOPHiA GENETICS (Nasdaq: SOPH), a cloud-native healthcare technology company and a global leader in data-driven medicine, today announced an update from the Company’s work with biopharma company Boundless Bio. SOPHiA GENETICS first partnered with Boundless Bio in 2022 to develop and deploy Boundless Bio’s extrachromosomal DNA (ecDNA) detection algorithm as a clinical trial device, to identify patients with ecDNA amplified tumors using the SOPHiA DDM™ Platform.

美国波士顿和瑞士罗尔，2024年9月5日讯——SOPHiA GENETICS（纳斯达克：SOPH）是一家云计算的本地医疗保健技术公司，也是数据驱动医学的全球领导者，今天宣布了该公司与生物制药公司Boundless Bio合作的最新进展。SOPHiA GENETICS于2022年首次与Boundless Bio合作，开发并部署了Boundless Bio的染色体外DNA（ecDNA）检测算法作为临床试验设备，以使用SOPHiA DDM™平台识别ecDNA扩增肿瘤患者。

The two companies collaborated with precision medicine clinical research organization (CRO) Precision for Medicine, which contributes its state-of-the-art, CAP-accredited, CLIA-certified laboratory services to Boundless Bio’s POTENTIATE Phase 1/2 clinical trial by successfully validating a proprietary workflow to process patient samples..

这两家公司与精准医学临床研究组织（CRO）precision for medicine合作，该组织通过成功验证专有工作流程来处理患者样本，为Boundless Bio的强化1/2期临床试验提供了最先进的、CAP认证的、CLIA认证的实验室服务。。

It is well established that oncogenic alterations, such as mutations and fusions, can lead to malignant cellular growth that results in cancer. While approved targeted agents are available to treat several types of oncogenic mutations, patients whose cancers harbor oncogene amplification typically do not derive the same benefit.

众所周知，致癌改变（例如突变和融合）可导致恶性细胞生长，从而导致癌症。虽然已批准的靶向药物可用于治疗几种类型的致癌突变，但患有癌基因扩增的癌症患者通常不会获得相同的益处。

Oncogenes can be amplified not only on chromosomes but also on ecDNA, which are cancer-specific, circular fragments of DNA that are a root cause of oncogene amplification in over 14 percent of patients with cancer. Boundless Bio targets ecDNA as a novel therapeutic axis in oncogene amplified cancers..

癌基因不仅可以在染色体上扩增，还可以在ecDNA上扩增，ecDNA是癌症特异性的环状DNA片段，是超过14%的癌症患者致癌基因扩增的根本原因。无限生物靶向ecDNA作为癌基因扩增癌症的新型治疗轴。。

Together, SOPHiA GENETICS and Boundless Bio pioneered the ecDNA Solution (ECS) algorithm to detect the presence of ecDNA using routine clinical next-generation sequencing (NGS) data. ECS is the first ecDNA clinical trial assay and was designed by SOPHiA GENETICS in alignment with FDA guidelines as an Investigational Use Only Clinical Trial Assay (IUO CTA).

SOPHiA GENETICS和Boundless Bio共同开创了ecDNA解决方案（ECS）算法，使用常规的临床下一代测序（NGS）数据检测ecDNA的存在。ECS是第一个ecDNA临床试验测定法，由SOPHiA GENETICS根据FDA指南设计，作为仅用于研究的临床试验测定法（IUO CTA）。

SOPHiA GENETICS provides data and analytical support for the device usage in Boundless Bio’s ongoing, first-in-human POTENTIATE Phase 1/2 study of its lead ecDNA-directed therapy (ecDTx), BBI-355..

SOPHiA GENETICS为Boundless Bio正在进行的首次人类强化1/2期研究中的设备使用提供了数据和分析支持，该研究针对其主要的ecDNA定向疗法（ecDTx），BBI-355。。

“The work we’ve done with SOPHiA GENETICS over the last two years to develop ECS is vital to identify patients with ecDNA amplified tumors for our POTENTIATE clinical trial of BBI-355,” said Peter Krein, Ph.D., Senior Vice President of Precision Medicine at Boundless Bio. “The capabilities that SOPHiA GENETICS provides, from assay development to clinical trial use, help enable this first-in-human precision medicine clinical trial.”.

“在过去的两年中，我们与SOPHiA GENETICS合作开发ECS的工作对于我们的BBI-355强化临床试验中鉴定ecDNA扩增肿瘤患者至关重要，”Boundless Bio精密医学高级副总裁Peter Krein博士说。“SOPHiA GENETICS提供的能力，从分析开发到临床试验使用，有助于实现这项首次在人类精密医学临床试验中的应用。”。

“We are excited to see our SOPHiA DDM™ Platform’s capabilities continue to be delivered across the clinical trial continuum through our ground-breaking collaboration with Boundless Bio. We are very excited at the prospect of contributing to meaningful clinical advances for patients with ecDNA-driven oncogene amplified cancers,” said Philippe Menu, M.D., PhD., Chief Medical Officer and Chief Product Officer, SOPHiA GENETICS..

医学博士Philippe Menu说：“我们很高兴看到我们的SOPHiA DDM™平台的功能通过与Boundless Bio的开创性合作继续在整个临床试验过程中提供。我们非常高兴能够为ecDNA驱动的癌基因扩增癌症患者的有意义的临床进展做出贡献。”。，SOPHiA GENETICS首席医疗官和首席产品官。。

SOPHiA GENETICS provides a technology-agnostic cloud-native platform for the computing, standardization and analysis of genomic data, allowing inputs from any leading NGS technology. The decentralized SOPHiA DDM™ Platform breaks barriers inherent to the traditional lab approach, allowing for global reach into major hospitals and academic centers.

SOPHiA GENETICS为基因组数据的计算，标准化和分析提供了一个与技术无关的云原生平台，允许来自任何领先NGS技术的输入。分散的SOPHiA DDM™平台打破了传统实验室方法固有的障碍，允许全球进入主要医院和学术中心。

This technology will expedite the implementation of clinical diagnostics and streamline market entry for pharmaceutical companies..

这项技术将加快临床诊断的实施，并简化制药公司的市场进入。。

Precision for Medicine incorporates scientific expertise and clinical trial excellence to deliver critical insights into patient biology. Precision is supporting the POTENTIATE clinical trial by adapting its diagnostic workflow to ensure a seamless connection with the SOPHiA DDM™ Platform. Results from testing of POTENTIATE trial participants’ biopsy samples will be used to further analyze clinical activity of the investigational drug BBI-355 in specific patient populations.

Precision for Medicine结合了科学专业知识和卓越的临床试验，为患者生物学提供了重要的见解。Precision通过调整其诊断工作流程来支持强化临床试验，以确保与SOPHiA DDM™平台的无缝连接。增强试验参与者活检样本的测试结果将用于进一步分析研究药物BBI-355在特定患者人群中的临床活性。

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“Working side-by-side with Boundless Bio and SOPHiA GENETICS, Precision for Medicine has generated a novel and seamless platform unlike any other that enables a new model for clinical trial testing,” said Darren Davis, PhD, Senior Vice President, Precision for Medicine. “By expediting a more accurate patient selection process, we can exceed the industry standard for clinical trial enrollment and support the potential for new ecDNA-directed therapies to reach patients in a timely manner.”.

Precision for Medicine高级副总裁Darren Davis博士说：“Precision for Medicine与无限生物和SOPHiA GENETICS并肩工作，产生了一个新颖而无缝的平台，它不同于其他任何平台，可以为临床试验测试提供新的模型。”。“通过加快更准确的患者选择过程，我们可以超过临床试验注册的行业标准，并支持新的ecDNA指导疗法及时到达患者的潜力。”。

More information about this collaboration will be provided during the World Clinical Biomarkers & CDx event in Boston on September 5, 2024. Learn more about the event here and learn more about the Company’s BioPharma solutions here.

2024年9月5日在波士顿举行的世界临床生物标志物和CDx活动将提供有关这一合作的更多信息。。

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About SOPHiA GENETICS

关于SOPHiA GENETICS

SOPHiA GENETICS (Nasdaq: SOPH) is a cloud-native healthcare technology company on a mission to expand access to data-driven medicine by using AI to unlock insights to deliver world-class care to patients across the globe. It is the creator of SOPHiA DDM™, a platform that analyzes complex genomic and multimodal data and generates real-time, actionable insights for a broad global network of hospital, laboratory, and biopharma institutions.  For more information, visit SOPHiAGENETICS.COM and connect with us on LinkedIn. .

SOPHiA GENETICS（Nasdaq:SOPH）是一家云本地医疗保健技术公司，其使命是通过使用人工智能来释放见解，为全球患者提供世界一流的护理，从而扩大对数据驱动医学的访问。它是SOPHiA DDM™的创建者，该平台可分析复杂的基因组和多模式数据，并为医院，实验室和生物制药机构的广泛全球网络生成实时可行的见解。有关更多信息，请访问SOPHiAGENETICS。COM并通过LinkedIn与我们联系。。

About Precision for MedicinePrecision for Medicine is the first biomarker-driven clinical research and development services organization supporting life sciences companies in the use of biomarkers essential to targeting patient treatments more precisely and effectively. Precision applies a transformational approach to clinical research that integrates clinical trial design and execution with deep scientific knowledge, laboratory expertise, data sciences and advanced manufacturing solutions.

关于药物精密度Precision for Medicine是第一个生物标志物驱动的临床研究和开发服务组织，支持生命科学公司使用生物标志物，这对于更准确有效地针对患者治疗至关重要。Precision将一种变革性的方法应用于临床研究，将临床试验设计和执行与深度科学知识、实验室专业知识、数据科学和先进制造解决方案相结合。

This convergence is driving faster clinical development and approval. Precision for Medicine is part of Precision Medicine Group, with 3,400 people in 40 locations globally across North America, Europe and Asia-Pacific. For more information, visit PrecisionForMedicine.com..

这种融合正在推动更快的临床开发和批准。Precision for Medicine是Precision Medicine Group的一部分，在北美、欧洲和亚太地区的40个地点拥有3400名员工。有关更多信息，请访问PrecisionForMedicine.com。。

SOPHiA GENETICS products are for Research Use Only and not for use in diagnostic procedures, unless specified otherwise. The information in this press release is about products that may or may not be available in different countries and, if applicable, may or may not have received approval or market clearance by a governmental regulatory body for different indications for use.

除非另有说明，否则SOPHiA GENETICS产品仅供研究使用，不用于诊断程序。本新闻稿中的信息是关于不同国家可能提供或不提供的产品，如果适用，可能已经或可能尚未获得政府监管机构对不同使用适应症的批准或市场许可。

Please contact support@sophiagenetics.com to obtain the appropriate product information for your country of residence. .

请联系support@sophiagenetics.com获取您居住国家的适当产品信息。。

SOPHiA GENETICS Forward-Looking Statements:

SOPHiA GENETICS前瞻性声明：

This press release contains statements that constitute forward-looking statements. All statements other than statements of historical facts contained in this press release, including statements regarding our future results of operations and financial position, business strategy, products, and technology, as well as plans and objectives of management for future operations, are forward-looking statements.

本新闻稿包含构成前瞻性声明的声明。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，包括关于我们未来经营成果和财务状况、经营战略、产品和技术以及未来经营管理计划和目标的声明。

Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including those described in our filings with the U.S.

。此类报表存在风险和不确定性，由于各种因素，包括我们向美国提交的文件中所述的因素，实际结果可能与前瞻性报表中明示或暗示的结果存在重大差异。

Securities and Exchange Commission. No assurance can be given that such future results will be achieved. Such forward-looking statements contained in this press release speak only as of the date hereof. We expressly disclaim any obligation or undertaking to update these forward-looking statements contained in this press release to reflect any change in our expectations or any change in events, conditions, or circumstances on which such statements are based, unless required to do so by applicable law.

证券交易委员会。不能保证将来会取得这样的结果。本新闻稿中包含的此类前瞻性声明仅在本新闻稿发布之日有效。除非适用法律要求，否则我们明确否认有义务或承诺更新本新闻稿中包含的前瞻性声明，以反映我们预期的任何变化或此类声明所依据的事件、条件或情况的任何变化。

No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements..

对于任何此类前瞻性陈述的准确性，均不作任何陈述或保证（明示或暗示）。。

Media Contact: Kelly Katapodismedia@sophiagenetics.com

媒体联系人：KellyKatapodismedia@sophiagenetics.com