Foundation Medicine Launches FoundationOne®MRD, First-of-Its-Kind Molecular Residual Disease Test to Combine Structural Variants and Digital PCR

Enables ultra-sensitive molecular disease detection, with high specificity

Provides accelerated results, with the personalized tumor fingerprint and initial blood test expected within approximately 2 to 3 weeks from the sample receipt, and subsequent blood test results anticipated within 1 to 3 days

BOSTON--(BUSINESS WIRE)--Foundation Medicine, Inc., a global, patient-focused precision medicine company, today announced the launch of FoundationOne®MRD, a molecular residual disease (MRD) test.¹ This launch follows the completion of Roche’s acquisition of SAGA Diagnostics. FoundationOne MRD is the first-of-its-kind MRD test to combine structural variants and digital PCR, enabling ultra-sensitive MRD detection, with high specificity.²

FoundationOne MRD leverages a differentiated approach designed to deliver highly sensitive and specific MRD detection alongside an accelerated turnaround time for healthcare providers. The personalized tumor fingerprint and initial blood test can be expected within approximately 2 to 3 weeks from the sample receipt, and subsequent blood test results can be anticipated within 1 to 3 days. This new MRD offering is covered by Medicare for cancer recurrence monitoring in early-stage breast cancer across all subtypes, with plans for a global launch.³

“FoundationOne MRD represents the next bold step in our mission to transform cancer care throughout a patient’s experience,” said Dan Malarek, CEO of Foundation Medicine. “FoundationOne MRD offers healthcare providers and patients a powerful solution leveraging a proprietary combination of whole genome sequencing (WGS) and digital PCR to reliably detect and monitor structural variants. With our deep expertise, we will incorporate FoundationOne MRD into our comprehensive portfolio to bring answers to even more people.”

FoundationOne MRD enriches Foundation Medicine's suite of diagnostics tools, empowering healthcare providers to identify disease recurrence earlier, select the best therapies for patients and monitor treatment response over time.

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®MRD

FoundationOne®MRD is performed by SAGA Diagnostics US, Inc. It is a tissue-informed liquid biopsy assay for the detection of circulating tumor DNA (ctDNA). The test entails whole genome sequencing (WGS) of a patient's tumor specimen to identify candidate structural variants (SVs). This information is used to generate a customized multiplex digital PCR (dPCR) fingerprint for up to 16 SVs. This patient-specific dPCR assay is then used to detect the present or absence of ctDNA. The assay is a laboratory developed test that was developed, and its performance characteristics determined, by SAGA Diagnostics. FoundationOne MRD has not been cleared or approved by the U.S. Food and Drug Administration.

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

^1 FoundationOne MRD is performed by SAGA Diagnostics US, Inc. and has not been cleared or approved by the FDA.

^2 Data on File, Foundation Medicine, Inc., 2026.

^3 Not approved by New York State.