CAMBRIDGE, Mass.—Boston-area molecular information company Foundation Medicine Inc., which is “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,” announced in May that it had obtained a CE mark for FoundationOne, the company’s first clinical product, allowing it to be placed on the market in the European Economic Area.
FoundationOne is described as “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.”
FoundationOne uses next-generation sequencing in routine cancer specimens to interrogate all genes “somatically altered in human cancers that are validated targets for therapy or unambiguous drivers of oncogenesis based on current knowledge,” the company says, and it “reveals all classes of genomic alterations, including base substitutions, insertions, deletions, copy number alterations and select rearrangements.”
FoundationOne reportedly 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.
The CE mark wasn’t the only extra-U.S. news for the company, though. Foundation Medicine announced at the same time that it has added to its growing global business partners by establishing a partnership with Barcelona, Spain-based Laboratorios LETI for the distribution of the company's clinical products to physicians in Spain and Portugal. The company anticipates this partnership will serve as a model for similar commercial relationships with leading distributors in select markets around the world.
In addition, and also keeping with the increasingly international viewpoint of the company, Foundation Medicine announced the appointment of Urmi Prasad Richardson as international vice president to lead its ongoing international commercialization efforts from an office in Germany. She brings more than 15 years of global experience developing and executing commercialization plans and strategic operations, specializing in molecular diagnostics and medical devices. Prior to joining Foundation Medicine, Richardson held leadership positions at Chiron, Novartis and Immucor.
“To date, we have reported clinical tests to customers in more than 40 countries outside of the United States, and with the addition of Urmi and other professionals to our commercial team, we are poised to further develop our international strategy and continue to grow our global business to support the increasing demand for our clinical products,” said Dr. Kevin Krenitsky, chief commercial officer and senior vice president of international strategy for Foundation Medicine. “We are very pleased to have received a CE mark and look forward to expanding the availability and adoption of FoundationOne to customers in the European oncology community.”
In addition to FoundationOne for solid tumors, the company also has the clinical assay FoundationOne Heme for hematologic malignancies, sarcomas and pediatric cancers, but the company has not yet filed an application for a CE mark for FoundationOne Heme.
As part of Foundation Medicine's ongoing international collaborations, FoundationOne is also being used for comprehensive genomic profiling in the WINTHER trial, an ongoing clinical trial to provide biology-oriented targeted therapies to patients with advanced solid tumors. The trial was initiated by the internationally renowned WIN Consortium in personalized cancer medicine, of which Foundation Medicine is a member.
“Cancer care is undergoing a paradigm shift in which each patient's treatment options can be informed by the molecular alterations driving a patient's tumor,” said Dr. Jean-Charles Soria, professor of medicine and medical oncology at South Paris University, chairman of the Drug Development Department at the Gustave Roussy Cancer Campus and principal investigator of the WINTHER trial. “With more and more targeted cancer therapies becoming available, physicians need access to comprehensive genomic profiling in clinical care to evaluate the best treatment options or clinical trials for each patient.”