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PathAI Announces Exclusive Collaboration with Roche Tissue Diagnostics to Advance AI-enabled Interpretation for Companion Diagnostics

Relationship Aims to Uniquely Support Biopharma Companies in Advancing Precision Medicine

February 13, 2024, Boston, MA - PathAI, Inc., a leading AI-powered precision pathology company, today announced an expanded and exclusive relationship with Roche Tissue Diagnostics (RTD) that will bring AI-enabled interpretation to companion diagnostics. Building upon the success of their initial partnership announced in October of 2021, this expanded collaboration will provide an integrated and streamlined solution for biopharma sponsors looking to develop AI-enabled companion diagnostics.

Under this agreement, PathAI will exclusively work with Roche Tissue Diagnostics (RTD) to develop AI-enabled digital pathology algorithms in the companion diagnostics space. RTD will work exclusively with PathAI for a pre-specified term as the sole external algorithm development company for AI-powered companion diagnostics, while retaining the ability to continue to develop its own algorithms for companion diagnostics. PathAI will retain the ability to freely develop algorithms outside of companion diagnostics. 

RTD and PathAI will create an integrated CDx assay, plus algorithm development process, to provide biopharma sponsors a seamless solution for AI-enabled companion diagnostics. With the increasing investment in immuno-oncology (IO) and now antibody drug conjugates (ADCs), the need for diagnostic tools that are optimized for patient selection will be critical for development, regulatory, and commercial success.


"This collaboration with Roche is a testament to our shared commitment to advancing the field of digital pathology and AI-enabled diagnostics for both drug development and clinical care,” said Dr. Andy Beck, CEO and Co-Founder of PathAI. “High medical value diagnostic products with seamless integration into the laboratory workflow will accelerate the transition to digital pathology as the standard to aid clinicians in diagnosis and biomarker characterization."

These co-developed, AI-enabled assays will be commercialized globally through Roche’s navify® Digital Pathology platform. PathAI will continue to distribute its AISight® Image Management System (IMS), and its broad portfolio of algorithmic products. 

“As the market leader in companion diagnostics, we strive to continuously bring new innovations in personalized healthcare,” said Jill German, Head of Roche Tissue Diagnostics. “This collaboration with PathAI will allow us to accelerate our ability to meet the demand from biopharma companies looking to develop AI-enabled companion diagnostics, and provide them with a powerful end-to-end solution in the pursuit of precision therapeutics.”

To learn more about this partnership, contact PathAI (BD@PathAI.com) to organize a meeting.

About PathAI, Inc.:

PathAI is a recognized leader in the biopharma partnering space, uniquely combining AI-powered pathology solutions with end-to-end central pathology and histology services. The company supports biopharma partners in executing clinical trials where pathology-based endpoints, biomarker classification, and/or superior histology quality are critical to successfully gauging therapeutic efficacy, accelerating drug development for complex diseases. PathAI has already supported multiple Phase 2 clinical trials in NASH, IBD, and breast cancer, as well as oncology neoadjuvant trials, and is now expanding into larger scale global Phase 3 studies, as well as additional indications.

PathAI provides a fully integrated approach to clinical trials, enabling pharma partners to leverage the power of AI without the heavy lift of implementation. This helps reduce the impact of challenges associated with clinical trials, including unreliable turnaround times, variable histology, stain or scan/digitization quality, and challenging assessment of histological endpoints. The lab offers all major immunohistochemistry staining platforms, with flexible workflows across different scanners, stains, and biopsy types, which improves the quality of clinical trials. Services include access to PathAI’s extensive network of over 500 US Board Certified pathologists to perform high quality reading with rapid turnaround time in a cost-effective manner, plus seamless integration of PathAI's advanced AI-solutions to ensure high-quality, reproducible results with every scan.

PathAI is headquartered in Boston, MA, and manages a CAP/CLIA-certified diagnostics clinical laboratory (formerly known as Poplar Healthcare) – one of the country’s largest anatomic pathology labs – in Memphis, TN. For more information, please visit www.pathai.com.

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