Foundation Medicine obtains CE mark for FoundationOne

Published on May 12, 2014 at 8:54 AM · No Comments

Foundation Medicine, Inc. (NASDAQ: FMI) today announced that it has obtained a CE mark for FoundationOne®. The CE mark allows FoundationOne to be placed on the market in the European Economic Area. In addition, Foundation Medicine 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.

Foundation Medicine also announced the appointment of Urmi Prasad Richardson as vice president, international to lead its ongoing international commercialization efforts. Ms. Richardson 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, Ms. Richardson held leadership positions at Chiron, Novartis and Immucor. Ms. Richardson will be based in Germany.

"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 Kevin Krenitsky, M.D., chief commercial officer and senior vice president of international strategy, 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."

The company's clinical assays, FoundationOne for solid tumors and FoundationOne Heme for hematologic malignancies, sarcomas and pediatric cancers, provide a fully informative genomic profile to identify the molecular alterations in a patient's cancer and match them with relevant targeted therapies and clinical trials. Foundation Medicine 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 Jean-Charles Soria, M.D., Ph.D., professor of medicine and medical oncology at South-Paris University; chairman, Drug Development Department, 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."

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