• Pathlight™, a personalized, tumor-informed molecular residual disease (MRD) platform, will expand Foundation Medicine’s testing capabilities
• Pathlight uses a proprietary combination of whole genome sequencing (WGS) and digital PCR to identify and track structural variants (SVs) enabling ultra-sensitive MRD detection

BOSTON: 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 platform1 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,2 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®Monitor3 and Foundation Medicine’s tissue-informed whole genome sequencing molecular residual disease test (Tissue-Informed WGS MRD) available for research use.4 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. ​​​

Foundation Medicine and FoundationOne are registered trademarks of Foundation Medicine, Inc.

SAGA Diagnostics is a registered trademark and Pathlight is a trademark of SAGA Diagnostics.

About Foundation Medicine

Foundation Medicine is a global, patient-focused precision medicine company delivering high-quality, transformative diagnostic solutions in cancer and other diseases. We provide tests and solutions to transform care throughout a patient’s experience, from defining a diagnosis to determining the appropriate treatment to ongoing monitoring. We help accelerate the development of new personalized therapies by leveraging our vast knowledge of precision medicine, real world data and AI-powered tools, expanding the information our diagnostic solutions provide to enable improved outcomes for patients. Every day, we are inspired to think differently to transform the lives of people living with cancer and other diseases. For more information, visit us at www.FoundationMedicine.com and follow us on LinkedIn, X, YouTube, Facebook, Instagram and BlueSky.

About FoundationOne®Monitor

FoundationOne®Monitor is a laboratory developed test that was developed and its performance characteristics determined by Foundation Medicine. This test has not been cleared or approved by the U.S. Food and Drug Administration. FoundationOne Monitor is a test for patients with solid malignant neoplasms that detects and longitudinally tracks circulating tumor DNA (ctDNA), reported as ctDNA tumor fraction (a determination of the amount of ctDNA as a fraction of total cell free DNA in a blood sample) as a biomarker for tumor content in the blood. Treatment decisions are the responsibility of the treating physician. ctDNA tumor fraction determination sensitivity may be limited if blood collection occurs within two weeks of surgery. ctDNA not detected status does not definitively indicate the absence of cancer and declining ctDNA tumor fraction does not necessarily indicate a response to therapy. This test is not designed to detect or report germline variation, nor does it infer hereditary cancer risk for a patient. This test is expected to have limited sensitivity in some cancer types due to limited ctDNA shed.

1 AXELIOS sequencing platform is in development and not commercially available.

2 Not approved by New York State.

3 FoundationOne®Monitor is a laboratory developed test which has not been reviewed or approved by the FDA.

4 Tissue-Informed WGS MRD is For Research Use Only. Not for use in diagnostic procedures.

Fonte: Business Wire