Foundation Medicine, Inc. (NASDAQ:FMI) Files An 8-K Other Events
Item 8.01. Other Events.

On December 19, 2016, Foundation Medicine, Inc. obtained approval from the U.S. Food and Drug Administration (FDA) for FoundationFocus^™ CDx_BRCA for use as a companion diagnostic to aid in identifying women with ovarian cancer for whom treatment with Rubraca^™ (rucaparib), a therapy developed by Clovis Oncology, Inc., is being considered. FoundationFocus CDx_BRCA is a next generation sequencing assay for qualitative detection of BRCA1 and BRCA2 alterations in ovarian tumor tissue. If a patient is positive for any of the deleterious BRCA gene mutations, the patient may be eligible for treatment with Rubraca.

About Foundation Medicine, Inc. (NASDAQ:FMI)

Foundation Medicine, Inc. is a molecular information company. The Company sells products that are enabled by its molecular information platform to physicians and biopharmaceutical companies. The Company’s segment is the business of delivering molecular information about cancer to its customers. Its products provide genomic information about each patient’s individual cancer, enabling physicians to optimize treatments in clinical practice and biopharmaceutical companies to develop targeted oncology therapies. Its flagship clinical molecular information products, FoundationOne for solid tumors, and FoundationOne Heme for blood-based cancers or hematologic malignancies, including leukemia, lymphoma, myeloma and advanced sarcomas, are genomic profiles designed for use in the routine care of patients with cancer. Its other products include FoundationACT (Assay for Circulating Tumor deoxyribonucleic acid (DNA)), GeneKit, FoundationCORE, FoundationICE and the SmartTrials program.

Foundation Medicine, Inc. (NASDAQ:FMI) Recent Trading Information

Foundation Medicine, Inc. (NASDAQ:FMI) closed its last trading session down -0.40 at 19.95 with 178,055 shares trading hands.