Roche’s Foundation Medicine rebranded Saga Diagnostics’ minimal residual disease (MRD) platform following the company’s $595 million Saga acquisition earlier this year, positioning the test for use beyond its initial breast cancer footprint. The assay is now marketed as FoundationOne MRD and is built on tissue-derived full genome sequencing to select structural variants, which are then tracked with patient-specific digital PCR. Foundation Medicine said the workflow is designed to be delivered across laboratories because the digital PCR component can be run on its own systems, including Roche’s Digital Lightcycler. The company emphasized that using structural variants may improve sensitivity and specificity relative to point-mutation-only approaches, where sequencing errors and tumor evolution can distort MRD calls over time. In parallel, the company is working on end-to-end longitudinal workflows intended to support circulating tumor DNA (ctDNA) monitoring and wider clinical adoption of the structural-variant-to-digital-PCR model. Foundation Medicine Chief Medical Officer Todd Druley also highlighted the “stable” nature of structural variants compared with mutation profiles that may shift under therapy pressure. Overall, the relaunch and indication expansion signal Roche’s intent to turn next-generation WGS-informed MRD into a scalable, multi-cancer monitoring product rather than a single-disease technology.
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