Myriad Genetics and SOPHiA GENETICS to Develop an Innovative Companion Diagnostic Offering in Liquid Biopsy
Myriad Genetics (Nasdaq: MYGN) and SOPHiA GENETICS (Nasdaq: SOPH) have announced a strategic collaboration to develop a global liquid biopsy companion diagnostic (CDx) test. The partnership combines Myriad's U.S. laboratory capabilities with SOPHiA GENETICS' network of over 800 institutions across 70+ countries.
The initial focus will be on MSK-ACCESS® powered with SOPHiA DDM™, a liquid biopsy test developed with Memorial Sloan Kettering Cancer Center that detects genomic alterations from blood samples using ctDNA analysis. Myriad will handle U.S. regulatory submissions, while SOPHiA GENETICS will manage international regulatory processes.
Myriad Genetics (Nasdaq: MYGN) e SOPHiA GENETICS (Nasdaq: SOPH) hanno annunciato una collaborazione strategica per sviluppare un test diagnostico complementare globale di biopsia liquida (CDx). La partnership combina le capacità di laboratorio statunitensi di Myriad con la rete di SOPHiA GENETICS, che comprende oltre 800 istituzioni in più di 70 paesi.
L’obiettivo iniziale sarà MSK-ACCESS® alimentato da SOPHiA DDM™, un test di biopsia liquida sviluppato con Memorial Sloan Kettering Cancer Center che rileva alterazioni genomiche a partire da campioni di sangue tramite analisi di ctDNA. Myriad si occuperà delle submission regolatorie negli Stati Uniti, mentre SOPHiA GENETICS gestirà i processi regolatori internazionali.
Myriad Genetics (Nasdaq: MYGN) y SOPHiA GENETICS (Nasdaq: SOPH) han anunciado una colaboración estratégica para desarrollar un test diagnóstico complementario de biopsia líquida (CDx) a nivel mundial. La asociación combina las capacidades de laboratorio de Myriad en EE. UU. con la red de SOPHiA GENETICS, que agrupa a más de 800 instituciones en 70+ países.
El enfoque inicial estará en MSK-ACCESS® impulsado por SOPHiA DDM™, un test de biopsia líquida desarrollado con el Memorial Sloan Kettering Cancer Center que detecta alteraciones genómicas a partir de muestras de sangre mediante análisis de ctDNA. Myriad gestionará las presentaciones regulatorias en EE. UU., mientras que SOPHiA GENETICS se encargará de los procesos regulatorios internacionales.
마이어드 제네틱스(Nasdaq: MYGN)와 SOPHiA GENETICS (Nasdaq: SOPH)는 글로벌 액체 바이오시피(CDx) 동반진단 테스트를 개발하기 위한 전략적 협력을 발표했습니다. 파트너십은 미국 내 마이어드의 실험실 역량과 800개 이상의 기관이 70개국 이상에 걸쳐 있는 SOPHiA GENETICS의 네트워크를 결합합니다.
초점은 초기 MSK-ACCESS®를 SOPHiA DDM™으로 구동하는 것으로, Memorial Sloan Kettering Cancer Center와 함께 개발된 액체 생검 테스트로 혈액 샘플의 ctDNA 분석을 통해 유전체 변이를 탐지합니다. 미국 내 규제 제출은 Myriad가 담당하고 국제 규제 절차는 SOPHiA GENETICS가 관리합니다.
Myriad Genetics (Nasdaq : MYGN) et SOPHiA GENETICS (Nasdaq : SOPH) ont annoncé une collaboration stratégique visant à développer un test compagnon de biopsie liquide (CDx) à l’échelle mondiale. Le partenariat combine les capacités de laboratoire américaines de Myriad avec le réseau de SOPHiA GENETICS comptant plus de 800 institutions dans plus de 70 pays.
L’objectif initial sera MSK-ACCESS® propulsé par SOPHiA DDM™, un test de biopsie liquide développé avec le Memorial Sloan Kettering Cancer Center qui détecte des altérations génomiques à partir d’échantillons sanguins via l’analyse ctDNA. Myriad se chargera des dépôts réglementaires aux États‑Unis, tandis que SOPHiA GENETICS gérera les procédures réglementaires internationales.
Myriad Genetics (Nasdaq: MYGN) und SOPHiA GENETICS (Nasdaq: SOPH) haben eine strategische Zusammenarbeit angekündigt, um einen globalen Liquid-Biopsy-Begleitdiagnostik-Test (CDx) zu entwickeln. Die Partnerschaft verbindet Myriads US-Laborkapazitäten mit dem Netzwerk von SOPHiA GENETICS, das über 800 Institutionen in mehr als 70 Ländern umfasst.
Der anfängliche Schwerpunkt liegt auf MSK-ACCESS® powered by SOPHiA DDM™, einem Liquid-Biopsy-Test, der mit dem Memorial Sloan Kettering Cancer Center entwickelt wurde und genomische Veränderungen aus Blutproben mittels ctDNA-Analyse nachweist. Myriad wird die US-amerikanischen behördlichen Einreichungen übernehmen, während SOPHiA GENETICS die internationalen regulatorischen Prozesse verwaltet.
تعلن شركة Myriad Genetics (ناسداك: MYGN) و SOPHiA GENETICS (ناسداك: SOPH) عن تعاون استراتيجي لتطوير اختبار تشخيص مصاحب سائل عالمي (CDx). تجمع الشراكة قدرات Myriad المخبرية في الولايات المتحدة مع شبكة SOPHiA GENETICS التي تضم أكثر من 800 مؤسسة في أكثر من 70 دولة.
يركّز الاهتمام الأول على MSK-ACCESS® المدعوم بـ SOPHiA DDM™، وهو اختبار سائل طوره Memorial Sloan Kettering Cancer Center ويكشف عن تغيّرات جينومية من عينات الدم من خلال تحليل ctDNA. ستتولى Myriad تقديم الطلبات التنظيمية في الولايات المتحدة، بينما ستدير SOPHiA GENETICS الإجراءات التنظيمية الدولية.
Myriad Genetics（纳斯达克：MYGN）与 SOPHiA GENETICS（纳斯达克：SOPH）宣布建立全球液体活检伴随诊断（CDx）测试的战略合作。该伙伴关系将 Myriad 的美国实验室能力与 SOPHiA GENETICS 在全球70多个国家、800多家机构的网络结合起来。
初步重点是由 SOPHiA DDM™ 提供动力的 MSK-ACCESS®，这是与 Memorial Sloan Kettering Cancer Center 共同开发的液体活检测试，通过血样的 ctDNA 分析检测基因组改变。Myriad 将负责在美国的监管提交，而 SOPHiA GENETICS 将管理国际监管流程。
- Strategic partnership combines Myriad's U.S. lab expertise with SOPHiA GENETICS' global network of 800+ institutions
- Development of innovative liquid biopsy CDx test that only requires a single blood draw
- Potential expansion of Myriad's product offerings and CDx program growth
- Access to key regulated markets globally through hybrid approach
- Regulatory approvals still pending in multiple jurisdictions
- Timeline for development and commercialization not specified
Insights
Myriad-SOPHiA partnership creates a powerful global CDx platform combining centralized U.S. testing with international reach across 70+ countries.
This strategic collaboration between Myriad Genetics and SOPHiA GENETICS represents a significant advancement in companion diagnostic (CDx) test development and commercialization. The partnership intelligently combines Myriad's established U.S. laboratory infrastructure with SOPHiA's extensive decentralized network spanning 800+ institutions across 70+ countries, creating a unique hybrid model for global CDx deployment.
The initial focus on liquid biopsy is particularly noteworthy. The MSK-ACCESS® powered with SOPHiA DDM™ technology allows detection of actionable genomic alterations from a simple blood draw using circulating tumor DNA (ctDNA) analysis. This non-invasive approach eliminates the need for surgical tissue biopsies, addressing a critical limitation in cancer diagnostics where tumor tissue may be inaccessible or insufficient for testing.
For pharmaceutical partners, this collaboration offers a streamlined pathway to implement CDx testing in clinical trials globally through a single partnership rather than establishing multiple regional agreements. The regulatory approach is strategically divided, with Myriad handling U.S. submissions and SOPHiA managing ex-U.S. markets, leveraging each company's established regulatory expertise and geographic strengths.
The deal enhances Myriad's product portfolio and potentially accelerates growth in its CDx business segment. For SOPHiA, it provides access to Myriad's established pharmaceutical partnerships and U.S. market presence. Most importantly, patients worldwide gain expanded access to advanced precision medicine tools that can match them to appropriate targeted therapies based on their unique tumor profiles.
SALT LAKE CITY and BOSTON, Sept. 23, 2025 (GLOBE NEWSWIRE) -- Myriad Genetics (Nasdaq: MYGN), a leader in molecular diagnostic testing and precision medicine, and SOPHiA GENETICS (Nasdaq: SOPH), an AI technology company transforming precision medicine, announced a strategic collaboration to develop and provide pharmaceutical companies with an innovative global liquid biopsy companion diagnostic (CDx) test. This partnership will leverage Myriad’s advanced laboratory capabilities in the U.S. to support global testing for clinical trials and SOPHiA GENETICS’ broad, decentralized network of more than 800 connected institutions in more than 70 countries for global test deployment.
“Serving patients and healthcare providers along the cancer care continuum is a strategic focus for Myriad Genetics,” said Sam Raha, President and CEO, Myriad Genetics. "We expect this collaboration with SOPHiA GENETICS to support the development and global commercialization of comprehensive CDx solutions for our BioPharma partners with the potential to positively impact patient lives, add an important product offering to the Myriad menu and support the growth of our CDx programs."
SOPHiA GENETICS and Myriad will initially focus on the liquid biopsy application, MSK-ACCESS® powered with SOPHiA DDM™. Developed in collaboration with Memorial Sloan Kettering Cancer Center, MSK-ACCESS® powered with SOPHiA DDM™ is an innovative liquid biopsy test that detects actionable genomic alterations from a single blood draw using proprietary, state-of-the-art algorithms which analyze circulating tumor DNA (ctDNA). By developing the application into a CDx, more patients can gain access to the benefits of this high-quality tumor profiling test, advancing personalized healthcare at scale.
Myriad will pursue regulatory submissions in the U.S., and SOPHiA GENETICS will manage regulatory submissions outside of the U.S. Both companies will collaborate across development activities. This innovative, hybrid approach is expected to provide pharmaceutical partners with access to key regulated markets globally.
“This collaboration represents a pivotal moment for the industry,” said Jurgi Camblong, Co-founder and CEO of SOPHiA GENETICS. “By combining the complementary strengths of a specialty lab leader and a global testing network, we are not only expanding access to innovative oncology testing but also laying the foundation for a new hybrid model in companion diagnostics. This collaboration will allow us to serve both clinical and pharmaceutical partners better, while accelerating the adoption of liquid biopsy solutions across key markets.”
SOPHiA GENETICS and Myriad will participate in a panel discussion at the World CB and CDx Summit in Boston and provide additional details on the collaboration.
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.
About Myriad Genetics
Myriad Genetics is a leading molecular diagnostic testing and precision medicine company dedicated to advancing health and well-being for all. Myriad Genetics develops and offers molecular tests that help assess the risk of developing disease or disease progression and guide treatment decisions across medical specialties where molecular insights can significantly improve patient care and lower healthcare costs. For more information, visit www.myriad.com.
Myriad Genetics Safe Harbor Statement
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including the company’s expectation that the collaboration with SOPHiA GENETICS to support the development and commercialization of comprehensive CDx solutions for the company’s BioPharma partners, add an important product offering to its menu and support the growth of its CDx programs, that by developing the application into a CDx, more patients will gain access to the benefits of this high-quality tumor profiling test, advancing personalized healthcare at scale, and that this innovative, hybrid approach is expected to provide pharmaceutical partners with access to key regulated markets globally. These “forward-looking statements” are 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. Such factors include those risks described in the company’s filings with the U.S. Securities and Exchange Commission, including the company’s Annual Report on Form 10-K filed on February 28, 2025, as well as any updates to those risk factors filed from time to time in the company’s Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. 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.
Media Contacts:
SOPHiA GENETICS: media@sophiagenetics.com
Myriad Genetics: pr@myriad.com
Investor Contacts:
SOPHiA GENETICS: Kellen Sanger (770) 655-4729 or IR@sophiagenetics.com
Myriad Genetics: Matt Scalo (801) 584-3532 or IR@myriad.com
FAQ
What is the new partnership between Myriad Genetics (MYGN) and SOPHiA GENETICS?
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