• Co-development program will utilize next-generation digital pathology platform and AI-based technology to provide real-time genomic testing results
  • Partnership to create new products enabling faster access to predictive information in treatment planning for patients with breast cancer

Agendia, Inc., a world leader in precision oncology for breast cancer, and Paige, a global leader in AI-based digital diagnostics, today announced a first of its kind strategic partnership that will redefine precision oncology. The partnership will enable co-development of treatment planning tools that integrate the cloud-based Paige Platform with genomic information from Agendia’s proprietary MammaPrint® and BluePrint® diagnostic tests for patients with breast cancer. These new products will enable faster access to predictive and prognostic information along the entire continuum of care, from diagnosis and early intervention to metastatic treatment planning.

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“Paige’s digital pathology platform is truly transformational for oncology and will catapult diagnostics forward as a whole. This partnership defines the democratization of treatment planning tools by accelerating access to these tests and the essential insights they provide for more patients globally,” said Mark Straley, Chief Executive Officer of Agendia. “Our goal is to provide same-day turnaround in most cases, enable earlier intervention, preserve limited biopsy or surgical tissue specimens, and extend key benefits to physicians and their patients with access to testing in countries where tissue ‘send out’ is not allowed. Whether a patient is in Manhattan or Mumbai, the ability to get real-time and accurate results from Agendia’s MammaPrint and BluePrint tests will improve how we are treating breast cancer today.”

The initial focus of the collaboration will be the development of digital tests for early treatment planning where genomic testing has played an essential role in determining recurrence risk and tumor biology as doctors and their patients make decisions about the path ahead. This can be especially important for patients with operable breast cancer. Beyond early intervention, AI-derived biomarkers will be used to augment genomic testing in the metastatic setting where a multitude of therapeutic options can add to the complexity of treatment planning.

“As the first company to receive FDA clearance, FDA breakthrough designation and two CE marks for digital and computational pathology products, Paige is delivering next-generation digital diagnostics that redefine how we approach cancer care,” said Leo Grady, Ph.D., Chief Executive Officer of Paige. “By combining our unique capabilities with Agendia’s leadership in breast cancer, we believe this innovative partnership can achieve our shared goal of transforming clear and actionable information into precision treatment for better patient outcomes. It will be the first of many AI-based diagnostic tests to come.”

For more information, please visit Agendia.com and Paige.ai.

About Agendia

Agendia is a precision oncology company headquartered in Irvine, California, committed to bringing early stage breast cancer patients and their physicians the information they need to make the best decisions for the full treatment journey. The company currently offers two commercially-available genomic profiling tests, supported by the highest levels of clinical and real world evidence, that provide comprehensive genomic information that can be used to identify the most effective breast cancer treatment possible for each patient.

MammaPrint®, the 70-gene breast cancer recurrence assay, is the only FDA-cleared risk of recurrence test backed by peer-reviewed, prospective outcome data and inclusion in both national and international treatment guidelines. BluePrint®, the 80-gene molecular subtyping assay, is the only commercially-available test that evaluates the underlying biology of a tumor to determine what is driving its growth. Together, MammaPrint® and BluePrint® provide a comprehensive genomic profile to help physicians make more informed decisions in the pre- and post-operative treatment settings.

By developing evidence-based novel genomic tests and conducting groundbreaking research while building an arsenal of data that will help treat breast cancer, Agendia aims to improve patient outcomes and support the evolving clinical needs of breast cancer patients and their physicians every step of the way, from initial diagnosis to cancer-free.

Agendia’s assays can be ordered on core biopsies or surgical specimens to inform pre- and post-operative treatment decisions. For more information on Agendia’s assays and ongoing trials, please visit www.agendia.com

About Paige

Paige was founded in 2017 by Thomas Fuchs, Dr.Sc. and colleagues from Memorial Sloan Kettering Cancer Center (MSKCC). The company builds computational pathology products designed so patients and their care teams can make effective, more informed treatment decisions. With this new class of AI-based technologies positioned to drive the future of diagnostics, Paige created a platform to deliver this novel technology to pathologists to transform their workflow and increase diagnostic confidence and productivity. Paige’s products deliver insights to pathologists and oncologists so they can arrive efficiently at more precise diagnoses for patients. Paige is the first company to receive FDA breakthrough designation for computational pathology products.

For additional information, please visit: https://www.Paige.ai, https://www.paigeplatform.com , Twitter and LinkedIn.

For Media: Terri Clevenger Westwicke/ICR Healthcare PR Tel: 203.856.4326 Terri.Clevenger@icrinc.com For Agendia Investors: Mike Cavanaugh Westwicke/ICR Healthcare IR Tel: 617.877.9641 Mike.Cavanaugh@westwicke.com