Foundation Medicine to Expand MRD Portfolio with Pathlight Platform

Foundation Medicine, Inc., an independent affiliate of Roche, announced plans to expand its monitoring portfolio with SAGA Diagnostics’ Pathlight, a personalized, tumor-informed molecular residual disease (MRD) platform. The expansion follows Roche’s entry into a definitive merger agreement to acquire SAGA Diagnostics for up to USD 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 by the third quarter of 2026; upon closing, the platform will be fully integrated into Foundation Medicine.

Pathlight combines whole‑genome sequencing (WGS) and digital polymerase chain reaction (dPCR) to identify and longitudinally track large‑scale genomic changes, known as structural variants (SVs). By optimizing for SVs, the platform supports ultra‑sensitive MRD detection tailored to each patient’s tumor profile. The company reports strong clinical performance to date in breast and colorectal cancer.

Access and coverage details were outlined. Pathlight is covered by Medicare for cancer recurrence monitoring in early‑stage breast cancer across all subtypes. It is currently available to patients in the United States and is not approved by New York State, with plans stated for international launch. Foundation Medicine also plans to leverage Roche’s AXELIOS sequencing platform (in development and not commercially available) and the Digital LightCycler PCR platform to develop a decentralized MRD solution intended to broaden patient access globally.

Pathlight will complement Foundation Medicine’s existing monitoring offerings, which include FoundationOne Monitor—a circulating tumor DNA (ctDNA) laboratory developed test that has not been cleared or approved by the U.S. Food and Drug Administration (FDA)—and a tissue‑informed WGS MRD assay available for research use only. Together, these tools are positioned to support treatment selection as well as monitoring of treatment response and disease recurrence across the cancer care continuum.

“Pathlight strengthens our comprehensive portfolio of diagnostic solutions and reinforces our commitment to transforming cancer care throughout a patient’s experience. MRD is one of the fastest‑growing areas within diagnostics and this technology provides us with a clinically available ultra‑sensitive offering,” said Dan Malarek, CEO of Foundation Medicine. "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. 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,” said Roopom Banerjee, Executive Chairman of SAGA Diagnostics.

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