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SOPHiA GENETICS Expands Collaboration with AstraZeneca to Enhance Detection of Breast and Prostate Cancer

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SOPHiA GENETICS (Nasdaq: SOPH) has expanded its collaboration with AstraZeneca to enhance breast and prostate cancer detection through advanced AI technology. The partnership focuses on developing an optimized next-generation sequencing (NGS) solution that employs AI algorithms to detect genetic mutations in the PIK3CA/AKT1/PTEN pathway.

The companies have already developed a prototype demonstrating improved sensitivity in mutation detection. SOPHiA GENETICS will implement a Privileged Access Program for selected clinical laboratories, with broader commercial availability expected in 2026. The program includes a multi-center real-world evidence study to validate the technology's effectiveness in clinical settings.

SOPHiA GENETICS (Nasdaq: SOPH) ha ampliato la propria collaborazione con AstraZeneca per potenziare la rilevazione del cancro al seno e della prostata mediante una tecnologia di IA avanzata. L'accordo punta a sviluppare una soluzione di sequenziamento di prossima generazione (NGS) ottimizzata che impieghi algoritmi di IA per rilevare mutazioni genetiche nel percorso PIK3CA/AKT1/PTEN. Le aziende hanno già sviluppato un prototipo che dimostra una maggiore sensibilità nel rilevare le mutazioni. SOPHiA GENETICS implementerà un Privileged Access Program per laboratori clinici selezionati, con una disponibilità commerciale più ampia prevista nel 2026. Il programma comprende uno studio multicentrico di real-world evidence per validare l'efficacia della tecnologia in contesti clinici.

SOPHiA GENETICS (Nasdaq: SOPH) ha ampliado su colaboración con AstraZeneca para mejorar la detección del cáncer de mama y de próstata mediante tecnología de IA avanzada. La asociación se centra en desarrollar una solución optimizada de secuenciación de nueva generación (NGS) que emplee algoritmos de IA para detectar mutaciones genéticas en la vía PIK3CA/AKT1/PTEN. Las empresas ya han desarrollado un prototipo que demuestra una mayor sensibilidad en la detección de mutaciones. SOPHiA GENETICS implementará un Privileged Access Program para laboratorios clínicos seleccionados, con una disponibilidad comercial más amplia prevista para 2026. El programa incluye un estudio multicéntrico de evidencia del mundo real para validar la efectividad de la tecnología en entornos clínicos.

SOPHiA GENETICS (Nasdaq: SOPH)가 더 발전된 인공지능 기술을 통해 유방암과 전립선암 탐지 향상을 목표로 AstraZeneca와의 협업을 확장했습니다. 파트너십은 AI 알고리즘을 활용해 PIK3CA/AKT1/PTEN 경로의 유전적 변이를 탐지하는 최적화된 차세대 시퀀싱(NGS) 솔루션을 개발하는 데 중점을 둡니다. 양사는 이미 변이 탐지에서 감도 향상을 보여주는 시제품을 개발했습니다. SOPHiA GENETICS는 선정된 임상 실험실을 위한 Privileged Access Program을 시행하고, 2026년에는 더 폭넓은 상용화가 기대됩니다. 이 프로그램에는 임상 현장에서 기술의 효과를 검증하기 위한 다기관 실세계 증거(real-world evidence) 연구가 포함됩니다.

SOPHiA GENETICS (Nasdaq: SOPH) a étendu sa collaboration avec AstraZeneca pour améliorer la détection du cancer du sein et de la prostate grâce à une technologie d’IA avancée. Le partenariat vise à développer une solution optimisée de séquençage de nouvelle génération (NGS) qui utilise des algorithmes d’IA pour détecter les mutations génétiques dans la voie PIK3CA/AKT1/PTEN. Les entreprises ont déjà développé un prototype démontrant une sensibilité accrue à la détection des mutations. SOPHiA GENETICS mettra en œuvre un Privileged Access Program pour des laboratoires cliniques sélectionnés, avec une disponibilité commerciale plus large attendue en 2026. Le programme comprend une étude multicentrique de preuves du monde réel pour valider l’efficacité de la technologie en milieu clinique.

SOPHiA GENETICS (Nasdaq: SOPH) hat seine Zusammenarbeit mit AstraZeneca erweitert, um die Erkennung von Brust- und Prostatakrebs durch fortschrittliche KI-Technologie zu verbessern. Die Partnerschaft konzentriert sich darauf, eine optimierte Next-Generation-Sequencing-Lösung (NGS) zu entwickeln, die KI-Algorithmen verwendet, um genetische Mutationen im PIK3CA/AKT1/PTEN-Pfad zu erkennen. Die Unternehmen haben bereits einen Prototyp entwickelt, der eine verbesserte Empfindlichkeit bei der Mutationsentdeckung zeigt. SOPHiA GENETICS wird ein Privileged Access Program für ausgewählte klinische Labors einführen, mit einer breiteren kommerziellen Verfügbarkeit, die 2026 erwartet wird. Das Programm umfasst eine multi-zentrische Real-World-Evidence-Studie, um die Wirksamkeit der Technologie in klinischen Anwendungen zu validieren.

SOPHiA GENETICS (Nasdaq: SOPH) وسّعت تعاونها مع AstraZeneca لتعزيز اكتشاف سرطان الثدي والبروستاتا من خلال تقنية الذكاء الاصطناعي المتقدمة. يتركّز الشراكة على تطوير حل تحسين تسلسل الجيل التالي (NGS) الذي يستخدم خوارزميات الذكاء الاصطناعي لاكتشاف طفرات جينية في مسار PIK3CA/AKT1/PTEN. لقد طوّرت الشركتان نموذجاً أولياً يُظهر حساسية محسّنة في اكتشاف الطفرات. ستنفذ SOPHiA GENETICS برنامج وصول مميز Privileged Access Program لمختبرات سريرية مختارة، مع توقع توفر تجاري أوسع في 2026. يشمل البرنامج دراسة أدلة واقعية متعددة المراكز للتحقق من فاعلية التكنولوجيا في البيئات السريرية.

SOPHiA GENETICS(纳斯达克:SOPH) 已扩大与 AstraZeneca 的合作,通过先进的人工智能技术提升乳腺癌和前列腺癌的检测。该合作聚焦开发一个优化的下一代测序(NGS)解决方案,利用 AI 算法检测 PIK3CA/AKT1/PTEN 通路中的遗传突变。双方已开发出一个原型,显示在突变检测方面的灵敏度有所提高。SOPHiA GENETICS 将为选定的临床实验室实施 Privileged Access Program,预计 2026 年实现更广泛的商业化。该计划还包括一个多中心的真实世界证据研究,以在临床环境中验证该技术的有效性。

Positive
  • Development of enhanced NGS solution with improved mutation detection sensitivity
  • Expansion of global testing network for PIK3CA/AKT1/PTEN pathway in tissue and liquid biopsy
  • Partnership with major pharmaceutical company AstraZeneca strengthens market position
  • Planned commercial launch in 2026 with validated real-world evidence
Negative
  • Extended timeline to commercial availability (2026)
  • Initial access limited to selected laboratories through Privileged Access Program

Insights

SOPHiA's expanded AstraZeneca collaboration advances AI-driven cancer diagnostics with promising commercial potential in 2026.

SOPHiA GENETICS' expanded collaboration with pharmaceutical giant AstraZeneca represents a significant advancement in precision oncology. The partnership focuses on developing an optimized next-generation sequencing solution enhanced by SOPHiA's AI algorithms to detect genetic mutations in the PIK3CA/AKT1/PTEN pathway—a critical molecular network implicated in breast and prostate cancers.

The technical achievement here shouldn't be underestimated. The companies have already developed a prototype demonstrating improved sensitivity in detecting complex mutations across the PTEN gene. This is particularly valuable as PTEN alterations contribute to both cancer development and treatment resistance, making them crucial biomarkers for precision medicine approaches.

The implementation strategy reveals careful commercial planning: SOPHiA will first deploy a Privileged Access Program to selected clinical laboratories specializing in breast and prostate cancer research, creating an opportunity to validate the technology in real-world settings while building relationships with key opinion leaders. This staged approach, followed by broader commercial availability expected in 2026, alongside a multi-center real-world evidence study, demonstrates a methodical path to market that balances scientific validation with business development.

SOPHiA's global network provides a ready distribution channel to drive adoption of advanced PIK3CA/AKT1/PTEN testing in both tissue and liquid biopsy samples—expanding patient access to precision therapies while potentially creating a valuable companion diagnostic opportunity that could generate sustainable revenue streams for the company.

This expanded collaboration between SOPHiA GENETICS and AstraZeneca creates mutual strategic advantages for both companies. For SOPHiA, partnering with a pharmaceutical powerhouse like AstraZeneca provides significant validation for their AI-driven diagnostic platform while potentially accelerating commercial adoption. For AstraZeneca, access to SOPHiA's advanced mutation detection capabilities could enhance patient selection for targeted therapies in their oncology portfolio.

The focus on the PIK3CA/AKT1/PTEN pathway is commercially astute. This pathway is implicated in approximately 40% of breast cancers and a significant portion of prostate cancers, representing large addressable markets. More importantly, several targeted therapies addressing these mutations are either approved or in late-stage development, making companion or complementary diagnostics in this area potentially lucrative.

The Privileged Access Program strategy creates a controlled launch environment that will generate valuable data while building relationships with key clinical laboratories—essentially creating centers of excellence that can drive broader adoption. The multi-center real-world evidence study adds another layer of data generation that could support both regulatory submissions and marketing efforts.

While commercial availability isn't expected until 2026, suggesting a relatively long revenue horizon, the press release indicates a prototype is already demonstrating improved sensitivity, suggesting technical development is well advanced. SOPHiA's global network of laboratories provides a ready distribution channel that could accelerate uptake once commercially available, potentially creating a faster-than-typical path to meaningful revenue contribution for a diagnostic product.

BOSTON, Sept. 22, 2025 /PRNewswire/ -- SOPHiA GENETICS (Nasdaq: SOPH), an AI technology company transforming precision medicine, today announced an expansion of its collaboration with AstraZeneca (LSE/STO/Nasdaq: AZN) from the World CB & CDx Summit in Boston. The companies aim to improve the diagnosis and treatment of breast and prostate cancer by developing an optimized next generation sequencing (NGS) solution that leverages SOPHiA GENETICS's AI algorithms to detect genetic mutations in the PIK3CA/AKT1/PTEN pathway.

The PIK3CA/AKT1/PTEN pathway is a key molecular signaling network that regulates how cells grow and survive, and its disruption is linked to the development of many cancers, including breast and prostate cancer. The PTEN gene, when altered, can contribute to cancer development and resistance to treatment. As part of this collaboration, the companies have developed an optimized NGS solution that deploys AI agents to analyze and detect genomic mutations across the full PTEN gene. A prototype of the enhanced solution has already demonstrated improved sensitivity in its ability to detect complex mutations across the pathway.

As part of the agreement, SOPHiA GENETICS will roll out a Privileged Access Program to selected clinical laboratories specializing in breast and prostate cancer research to validate sensitivity in a real-world setting, with broader commercial availability expected in 2026, alongside a multi-center real-world evidence study to further test its effectiveness. SOPHiA GENETICS's global network will also help drive adoption of advanced PIK3CA/AKT1/PTEN testing in both tissue and liquid biopsy to expand patient access to precision therapies.

"Each day brings new insights that transform our understanding of cancer. Partnering with innovative biopharma leaders like AstraZeneca allows us to translate these discoveries into action for breast and prostate cancer patients worldwide, representing another step forward in our mission to democratize data-driven medicine." said Ross Muken, President, SOPHiA GENETICS.

The expanded partnership highlights the shared commitment of SOPHiA GENETICS and AstraZeneca to drive innovation in precision oncology and to ensure that patients across the globe can benefit from advanced genomic testing and targeted treatments. To learn more, connect with SOPHiA GENETICS at the World CB & CDx Summit in Boston, MA from September 22-25, 2025.

For more information on SOPHiA GENETICS, visit SOPHiAGENETICS.COM, or connect on LinkedIn

About 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 deliver world-class care to patients with cancer and rare disorders across the globe. It is the creator of the SOPHiA DDM™ Platform, which 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 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. Please contact support@sophiagenetics.com to obtain the appropriate product information for your country of residence. 

SOPHiA GENETICS Forward-Looking Statements:  
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. 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. 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. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. 

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SOURCE SOPHiA GENETICS

FAQ

What is the new collaboration between SOPHiA GENETICS (SOPH) and AstraZeneca?

SOPHiA GENETICS and AstraZeneca are collaborating to develop an AI-powered NGS solution for detecting genetic mutations in the PIK3CA/AKT1/PTEN pathway to improve breast and prostate cancer diagnosis and treatment.

When will SOPHiA GENETICS' new cancer detection technology be commercially available?

The enhanced NGS solution is expected to be commercially available in 2026, following validation through a Privileged Access Program and multi-center real-world evidence study.

How does SOPHiA GENETICS' new cancer detection technology work?

The technology uses AI algorithms and next-generation sequencing (NGS) to analyze and detect genomic mutations across the full PTEN gene and PIK3CA/AKT1/PTEN pathway, which are crucial in cancer development.

What are the key benefits of SOPHiA GENETICS' expanded collaboration with AstraZeneca?

The collaboration aims to improve cancer diagnosis accuracy, expand patient access to precision therapies, and validate the technology through real-world testing in clinical laboratories specializing in breast and prostate cancer research.

How will SOPHiA GENETICS validate their new cancer detection technology?

The company will implement a Privileged Access Program with selected clinical laboratories and conduct a multi-center real-world evidence study to validate the technology's effectiveness in clinical settings.
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