Foundation Medicine to Strengthen Monitoring Portfolio with SAGA Diagnostics’ Tumor-Informed Molecular Residual Disease (MRD) Platform

Original from: business wire

Foundation Medicine, Inc., a global, patient-focused precision medicine company and an independent affiliate of Roche, announced it is set to expand its monitoring portfolio with SAGA Diagnostics’ tumor-informed molecular residual disease (MRD) platform as a result of Roche entering into a definitive merger agreement to acquire SAGA. Roche will pay a total of up to $595 million, inclusive of commercial and regulatory milestone payments. The transaction is subject to customary closing conditions including regulatory approvals, and is expected to close in Q3 2026, at the latest. Following the closing of the transaction, the platform will be fully integrated into Foundation Medicine.

Pathlight’s MRD platform will strengthen Foundation Medicine’s portfolio of high-quality diagnostic tests and solutions that support treatment selection, and the monitoring of both treatment response and disease recurrence. Foundation Medicine also plans to leverage Roche’s AXELIOS sequencing platform and the Digital LightCycler® PCR platform to develop a decentralized MRD solution which will enable patient access in healthcare settings worldwide.

Pathlight uses a proprietary combination of whole genome sequencing (WGS) and digital PCR to identify and track large-scale genomic changes known as structural variants (SVs). By optimizing for SVs, Pathlight enables ultra-sensitive MRD detection. Pathlight is covered by Medicare for cancer recurrence monitoring in early-stage breast cancer across all subtypes. It is currently available for patients within the United States, with plans for international launch.

“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.”

“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.”

Pathlight will expand Foundation Medicine’s monitoring portfolio, which includes FoundationOne®Monitor and Foundation Medicine’s tissue-informed whole genome sequencing molecular residual disease test (Tissue-Informed WGS MRD) available for research use. FoundationOne Monitor is a circulating tumor DNA (ctDNA) monitoring test which uses a blood sample to support healthcare providers with clarity on their patient’s response to treatment and inform next steps in care. The Tissue-Informed WGS MRD test monitors hundreds to thousands of tumor-specific short variants, enabling accurate quantification of ctDNA in patients with cancer for a more complete picture after treatment.

Source: Foundation Medicine to Strengthen Monitoring Portfolio with SAGA Diagnostics’ Tumor-Informed Molecular Residual Disease (MRD) Platform