CAMBRIDGE, Mass.--(BUSINESS WIRE)--Foundation Medicine, Inc. (NASDAQ: FMI) today announced the launch of an updated FoundationOne®, incorporating several enhancements that reflect the company’s ongoing commitment to innovation in patient care. The latest version of the most comprehensive genomic profile validated for clinical use features advancements to several components of this unique end-to-end solution, and will be commercially available, replacing the current version of FoundationOne, starting August 4, 2014.
“We are committed to continuously improving our products, both in content as well as testing processes, and maximizing value for patients and health care providers,” said Michael J. Pellini, M.D., president and CEO of Foundation Medicine. “FoundationOne continues to integrate the latest clinically relevant findings into a best-in-class product that fits seamlessly into routine clinical practice, allowing us to deliver the most comprehensive and relevant information to support decision-making by physicians, our biopharmaceutical partners, and other key stakeholders, with the goal of further improving patient outcomes.”
FoundationOne has been expanded to interrogate the entire coding region of 314 genes and select promoter and intronic regions in 29 genes to ensure patients benefit from the latest clinically relevant developments in cancer biology. FoundationOne will continue to be regularly updated with new clinically-relevant genes, informed by an exhaustive review of scientific and medical literature, expert consultations and Foundation Medicine’s extensive clinical experience. Performance of the platform has been enhanced by more efficient and robust computational biology algorithms and improvements to drive higher success rates on small tumor samples with low tumor content, such as fine needle aspirates.
“Our large and rapidly growing knowledgebase, containing our clinical experience from more than 15,000 patient cases across a wide range of tumor types, allows meaningful patterns to emerge that promote new understandings of not only the most common cancers, such as lung, breast and colon, but also rare or uncommon cancers with otherwise limited treatment options,” said Vincent Miller, M.D., chief medical officer of Foundation Medicine. “The use of FoundationOne not only supports today’s clinical practice, but adds to this knowledgebase with each patient sample, enhancing both our platform and the greater understanding of cancer. In this way, FoundationOne enables the oncologist to match each patient’s unique cancer to the appropriate targeted therapies and clinical trials, while also furthering the evolution of cancer care.”
FoundationOne, the company’s first clinical product, is a fully informative genomic profile for solid tumors used by oncologists to identify the molecular alterations in a patient's tumor and match those alterations with relevant targeted therapies and clinical trials. Using next-generation sequencing in routine cancer specimens, FoundationOne interrogates all genes somatically altered in human cancers that are validated targets for therapy or unambiguous drivers of oncogenesis based on current knowledge. It reveals all classes of genomic alterations including base substitutions, insertions, deletions, copy number alterations and select rearrangements. FoundationOne fits easily into the clinical workflow of the ordering physician, and test results are provided in an easy-to-interpret report supported by a comprehensive review of published literature. FoundationOne is a laboratory-developed test performed at Foundation Medicine's CLIA-certified lab. The test is accredited by CAP, is approved by the New York State Department of Health and has received a CE Mark. Please visit www.FoundationOne.com for more information.
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, sarcomas and pediatric cancers, each provide a fully informative genomic profile to identify a patient’s individual molecular alterations 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 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 launch of an enhanced version of FoundationOne, the increased utility of new knowledge reflected in the enhanced test, future updates to FoundationOne, and the potential impact of current and future enhancements to patient treatment. 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 risk that the enhanced version of FoundationOne does not perform as expected; that subsequent enhancements to FoundationOne are not developed; that future versions of FoundationOne do not impact the treatment of cancer; 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, 2013, 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.