Foundation Medicine, Inc. (NASDAQ:FMI) is a high end genomic cancer testing and information services company. Delays in obtaining reimbursement have caused guidance reductions, and shares have dropped significantly since Roche purchased over 50% of the company at $50 per share in early 2015. Now there is a definitive catalyst that we believe will be a game changer. Foundation Medicine has submitted an application to the FDA for approval of its tissue based test which could sanction its use as a companion diagnostic for FDA approved drugs covering over 40% of the metastatic cancer population in the U.S. Moreover, as part of the process, Foundation Medicine is simultaneously seeking CMS (the Medicare payer) coverage for the test. We expect approval to be obtained in the second half of 2017.
From Baron Discovery Fund's fourth quarter 2016 commentary.
