BOSTON, Mass. — Foundation Medicine, Inc. announced plans to strengthen its cancer monitoring portfolio by integrating SAGA Diagnostics’ tumor-informed molecular residual disease (MRD) platform, following Roche’s agreement to acquire SAGA in a deal valued at up to $595 million.
The transaction, which includes commercial and regulatory milestone payments, is expected to close by the third quarter of 2026, pending regulatory approvals and customary closing conditions. After completion, the MRD platform will be fully integrated into Foundation Medicine’s offerings.
The platform, known as Pathlight, is designed to enhance diagnostic capabilities by supporting treatment selection and enabling more precise monitoring of treatment response and disease recurrence. Foundation Medicine also plans to combine the platform with Roche’s AXELIOS sequencing system and Digital LightCycler PCR technology to develop a decentralized MRD solution aimed at expanding global patient access.
Pathlight uses a proprietary approach that combines whole genome sequencing and digital PCR to identify and track structural variants—large-scale genomic changes associated with cancer. This method allows for highly sensitive detection of residual disease. The test is currently covered by Medicare for monitoring cancer recurrence in early-stage breast cancer across all subtypes and is available to patients in the United States, with international expansion planned.
“Pathlight strengthens our comprehensive portfolio of diagnostic solutions and reinforces our commitment to transforming cancer care throughout a patient’s experience,” said Dan Malarek, CEO of Foundation Medicine. “MRD is one of the fastest-growing areas within diagnostics and this technology provides us with a clinically available ultra-sensitive offering. Pathlight has demonstrated strong clinical performance in breast and colorectal cancer, and we look forward to expanding its applicability across other tumor types and indications to improve the lives of even more patients.”
SAGA Diagnostics leadership said the partnership will help accelerate broader adoption of the technology.
“Our mission at SAGA is to intercept cancer early when patients are most treatable and curable,” said Roopom Banerjee, Executive Chairman of SAGA. “Foundation Medicine’s commercial scale and innovation accelerates our ability to bring this unique MRD platform to more patients worldwide. We are proud of our team for advancing innovation in the MRD field and commercially launching Pathlight to improve patient outcomes.”
The addition of Pathlight will expand Foundation Medicine’s existing monitoring portfolio, which includes FoundationOne Monitor, a circulating tumor DNA blood test used to assess treatment response and guide care decisions, as well as a tissue-informed whole genome sequencing MRD test currently available for research use.
