Foundation Medicine Launches Molecular Residual Disease (MRD) Test for Research Use in Early to Late-Stage Cancers Through its FlexOMx™ Lab

BOSTON - September 23, 2025 - Foundation Medicine, Inc., a precision medicine company transforming lives in cancer care and beyond, today announced the addition of a tissue-informed whole genome sequencing molecular residual disease (Tissue-informed WGS MRD) test to its portfolio of high-quality testing solutions. The test is currently available for research use in retrospective clinical trials.

Foundation Medicine's FlexOMx Lab™ now offers highly sensitive Tissue-informed WGS MRD test results for early and late-stage cancer research studies. The test monitors hundreds to thousands of tumor-specific variants, enabling accurate quantification of circulating tumor DNA (ctDNA) in patients with cancer for a more complete picture after treatment. Foundation Medicine's method offers high sensitivity and specificity in detecting potential cancer recurrence, even in samples with low tumor burden where other methods might misinterpret the signal as noise. In a feasibility study, Foundation Medicine's test was able to find tumor DNA at low levels, down to 1 part per 100,000 (10ppm, 0.001%).

"Foundation Medicine is setting a new standard for how our biopharmaceutical partners can monitor and understand cancer," said Troy Schurr, chief biopharma business officer at Foundation Medicine. "Our new Tissue-informed WGS MRD test gives partners a new tool for exploratory analysis in early to late-stage cancers, that offers highly specific and deep insights into a patient's response and resistance to therapy."

Foundation Medicine's Tissue-informed WGS MRD test allows biopharmaceutical partners to unlock rich multi-omics insights with an expanded monitoring portfolio that includes FoundationOne®Monitor for research use, a tissue-free treatment monitoring test.

For an even deeper look, biopharmaceutical partners can leverage Foundation Medicine's Tissue-informed WGS MRD test with the clinical trial assays based on FoundationOne®CDx or FoundationOne®Liquid CDx for comprehensive genomic profiling and identification of resistance mutations.

About Foundation Medicine At Foundation Medicine, our mission is to transform lives in cancer and beyond. We strive to provide multi-modal precision diagnostic solutions to transform cancer care throughout a patient's experience, from pre-diagnosis to ongoing management and monitoring. Leveraging our vast knowledge of precision medicine, we partner with biopharmaceutical companies to accelerate the development of new personalized therapies in cancer and in a range of other diseases. For more information, visit us at https://www.FoundationMedicine.com and follow us on LinkedIn, X, YouTube, Facebook and Instagram.

About FoundationOne®CDx FoundationOne®CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. FoundationOne CDx is for prescription use only and is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy. For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit https://www.F1CDxLabel.com.

About FoundationOne®Liquid CDxFoundationOne®Liquid CDx is a qualitative next generation sequencing based in vitro diagnostic test for prescription use only that uses targeted high throughput hybridization-based capture technology to analyze 324 genes utilizing circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood of advanced cancer patients. The test is FDA-approved to report short variants in over 300 genes and is a companion diagnostic to identify patients who may benefit from treatment with specific therapies (listed in Table 1 of the Intended Use) in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Patients who are negative for companion diagnostic mutations should be reflexed to tumor tissue testing and genomic alteration status confirmed using an FDA-approved tumor tissue test, if feasible. For the complete label, including companion diagnostic indications and complete risk information, please visit https://www.F1LCDxLabel.com.

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

Media Contact:Danielle Johns, [email protected]