CAMBRIDGE, Mass.--(BUSINESS WIRE)--Foundation Medicine, Inc. (NASDAQ:FMI) today announced 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. 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.
“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.”
About Foundation Medicine
Foundation Medicine (NASDAQ:FMI) is a molecular information company dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient's unique cancer. The company's clinical assays, FoundationOne® for solid tumors and FoundationOne® Heme for hematologic malignancies and sarcomas, provide a comprehensive genomic profile to identify the molecular alterations in a patient's cancer and match them with relevant targeted therapies and clinical trials. Foundation Medicine's molecular information platform aims to improve day-to-day care for patients by serving the needs of clinicians, academic researchers and drug developers to help advance the science of molecular medicine in cancer. For more information, please visit http://www.FoundationMedicine.com or follow Foundation Medicine on Twitter (@FoundationATCG).
Foundation Medicine® and FoundationOne® are registered trademarks of Foundation Medicine, Inc.
Cautionary Note Regarding Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the objectives, timeline, design and results of a clinical study to validate the company’s circulating tumor DNA (ctDNA) assay, and following completion of the study, the company’s ability to successfully validate the clinical utility of, and launch, a ctDNA assay, and the timing of any such launch. All such forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include the risks that the study will not enroll as quickly as anticipated, the study design is not effective, the company’s ctDNA assay does not perform as expected, the company is not able to develop and commercialize a ctDNA test, and the risks described under the caption “Risk Factors” in Foundation Medicine’s Annual Report on Form 10-K for the year ended December 31, 2014, which is on file with the Securities and Exchange Commission, as well as other risks detailed in Foundation Medicine’s subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Foundation Medicine undertakes no duty to update this information unless required by law.
1 Bettegowada, et al. Science Translational Medicine; Volume 6, Issue 224, February 2014