Personalized Molecular Monitoring Assay Uses Algorithms for Early Detection of ctDNA

A circulating tumor DNA (ctDNA) detection and molecular monitoring assay uses optimized algorithms for identifying patient-specific variants and a personalized assay design that allows for the detection of ctDNA in plasma.

Foundation Medicine, Inc., (Cambridge, MA, USA) has been granted a Breakthrough Device designation by the US Food and Drug Administration (FDA) for the use of FoundationOne Tracker assay in the detection of molecular residual disease, commonly known as MRD, in early-stage cancer after curative therapy. This molecular detection can help guide further therapy decisions depending on MRD status and an individual’s risk of relapse.

Image: FoundationOneCDx Test (Photo courtesy of Foundation Medicine)

In addition to the indications granted through the Breakthrough Device designation, FoundationOne Tracker’s personalized technology aims to address ctDNA detection and molecular monitoring in patients with both early- and advanced-stage cancers, including assessment of a patient’s response to therapy, as well as MRD detection, surveillance, and detection of molecular residual relapse following curative intent therapy.

“Personalized molecular disease monitoring enables early detection of ctDNA and can monitor for risk of relapse and track therapy response to help oncologists make personalized treatment plans for their patients,” said Brian Alexander, M.D., M.P.H., chief executive officer at Foundation Medicine. “We are enthusiastic about our work to accelerate development of this assay so that it can more quickly impact care decisions in the clinic.”

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Foundation Medicine, Inc.