Foundation Medicine’s sequencing diagnostics test for solid tumors that can detect cancer-causing mutations in 324 genes was approved by the FDA Thursday.
Foundation Medicine, Inc.’s sequencing diagnostics test for solid tumors that can detect cancer-causing mutations in 324 genes was approved by the U.S. Food and Drug Administration Thursday.
In addition to FDA approval, the U.S. Centers for Medicare & Medicaid Services announced preliminary national coverage of the vitro diagnostic (IVD) test, FoundationOne CDx (F1CDx). Final Medicare approval will be subject to public comment, the company said.
The F1CDx test is the second IVD to be approved and covered under the Parallel Review Program, the FDA said on Thursday. The Parallel Review Program facilitates earlier access to innovative medical technologies for Medicare beneficiaries. The F1CDx test is the first FDA-approved test of its kind for all solid tumors. News caused shares of Foundation One to shoot up on Thursday and share prices have continued to rise this morning. As of 9:50 a.m., shares are up more than 16 percent to $62.
According to Foundation Medicine, the F1CDx test assesses all classes of genomic alterations in 324 genes known to drive cancer growth. It provides physicians and care givers “potentially actionable information to help guide treatment decisions.” Additionally, the test is also indicated as a companion diagnostic for patients with certain types of non-small cell lung cancer (NSCLC), melanoma, colorectal cancer, ovarian cancer or breast cancer to identify those patients who may benefit from treatment with one of 17 on-label targeted therapies, including 12 therapies currently approved as first-line therapy for their respective indications, the company said.
Other companion diagnostics previously approved by the FDA match one test to one drug. However, the F1CDx is a more extensive test that provides information on a number of different genetic mutations that may help in the clinical management of patients with cancer, the FDA said in its announcement. The regulatory agency added that based on individual test results, the F1CDx can identify which patients with any of five tumor types may benefit from 15 different FDA-approved targeted treatment options. Its results provide patients and health care professionals access to all of this information in one test report, avoiding duplicative biopsies.
News of the FDA approval was hailed by FDA Commissioner Scott Gottlieb. The commissioner called the test a “breakthrough diagnostic that can help doctors tailor cancer treatments to improve medical outcomes and potentially reduce health care costs.”
Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said the F1CDx helps physicians make more informed healthcare decisions without “the often invasive process of extracting tumor samples multiple times to determine eligibility for a single treatment or enrollment in a clinical trial.” With one test, Shuren said doctors and their patients can evaluate several appropriate treatment options.
Foundation Medicine Chief Executive Officer Troy Cox called the FDA and CMS decision historic. Approval of the test “represents a major advancement in personalized cancer care,” Cox added.
“Physicians will have an FDA-approved test for all solid tumors in their toolkit that can inform targeted and immunotherapy selection, as well as identify patient opportunities for clinical trial participation. Beyond its implications for patient care, we expect that FoundationOne CDx will provide biopharma companies with an FDA-approved platform that can help accelerate drug development and enable personalized oncology care,” Cox said in a statement.
