On July 28, 2015 Foundation Medicine, Inc. (NASDAQ:FMI) reported the initiation of a large-scale, multi-center prospective clinical study to validate its circulating tumor DNA (ctDNA) assay for multiple, solid and hematologic tumor types (Press release, Foundation Medicine, JUL 28, 2015, View Source [SID:1234506722]). Expected to launch commercially in 2016, the ctDNA assay will complement FoundationOne for solid tumors and FoundationOne Heme for hematologic malignancies and provide healthcare practitioners with a full suite of analytically validated genomic profiling products to support the application of precision medicine and targeted therapies in cancer care.
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"Tumor tissue obtained by biopsy is the gold standard material from which we generate the requisite molecular information to guide the optimally targeted treatment of patients with cancer," said Francis Giles, M.D., Deputy Director of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University. "Blood based ‘liquid biopsy’ assays offer the potential to define actionable molecular lesions in patients in whom a tissue specimen can’t be safely obtained or is otherwise unavailable. We’re delighted to be part of this rigorously designed study which we anticipate will help bring a new, less invasive diagnostic option to our patients with cancer."
Study Rationale and Objectives
The presence of ctDNA in plasma is a well-established phenomenon and has led to recent innovation in the development of non-invasive tumor sequencing assays. However, the concentration of ctDNA compared to other cell free DNA fragments can vary significantly depending on tumor type and disease stage. For many cancer patients, this means that the proportion of detectable tumor DNA in the blood is extremely low1, making the detection of therapeutically relevant genomic alterations more difficult compared with tissue-based approaches. Importantly, up to 40% of patients shed no tumor DNA into the bloodstream1 and will thus test negative using ctDNA assays.
The challenge and opportunity is to commercialize a rigorously validated ctDNA assay that provides physicians with confidence in test results and affords genomic profiling to patients in whom otherwise few or no targeted treatment options would have been identified. To address these challenges, Foundation Medicine has launched a large, multi-center study to assess the potential utility of its ctDNA assay across various cancers and stages of disease. The study will also provide the analytic validation mandated for clinical use of a commercial ctDNA assay by establishing concordance of the assay in detecting genomic alterations from circulating tumor DNA as compared to alterations detected in tissue biopsies assessed by the company’s comprehensive genomic profile for solid tumors, FoundationOne.
"Innovation in genomic profiling is incredibly important in oncology and ctDNA assays, in particular, may offer tremendous potential for patients with cancer at certain stages of disease," added Samuel Klempner, M.D., Assistant Professor, Division of Hematology/Oncology at UC Irvine Health and a co-investigator in the study. "We’re optimistic that this study with Foundation Medicine will identify a less invasive option for a population of patients with cancer and reliably identify subsequent treatment options in select patients."
Luis E. Raez, M.D., Medical Director of the Memorial Cancer Institute, Associate Professor at Florida international University (FIU) in Miami, FL and co-investigator in the study, stated, "I am very excited to be participating in this study utilizing a liquid biopsy assay for my patients when tissue specimens are not available, and because this assay is being developed to the same caliber of standards as FoundationOne and FoundationOneHeme, where validation data and methodology will be best in class and made publicly available for peer-review by the oncology community."
The study is expected to be completed next year and it will include patients who are most likely to benefit from liquid-based genomic profiling, such as patients who relapse after standard non-targeted treatment. Approximately 20% of the patients in the study will include those with earlier-stage disease, allowing the company to investigate how different types of tumors shed DNA into the bloodstream at different stages of tumor growth and metastasis.
"There are no short cuts to commercializing clinical assays that inform therapeutic treatment options," said Vincent Miller, M.D., Chief Medical Officer of Foundation Medicine. "We are applying the same analytic rigor to our ctDNA assay as we applied to FoundationOne and FoundationOne Heme, both of which are considered gold standard assays for molecular profiling. Our aim with our ctDNA assay is not to replace tissue biopsies, but rather, to identify clinical settings for utilization of this innovation, including for example, tissue-limited situations. We look forward to defining the utility of this approach through the outcomes of this study and to launching this assay in 2016."