Foundation Medicine Advances Patient Access to Precision Medicine; Pursues Regulatory Approval for FoundationOne CDx™ in Japan
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FoundationOne CDx is the first
"Seeking approval for FoundationOne CDx in
FoundationOne CDx assesses genomic alterations in 324 genes known to drive cancer growth, providing potentially actionable information to help guide treatment decisions. It is indicated for use by health care professionals to help inform cancer treatment management in accordance with professional guidelines for patients with solid tumors. The first
"This collaboration further enables us to pursue personalized oncology care in Japan," said
About FoundationOne CDx
FoundationOne CDx is a next generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens. FoundationOne CDx is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit http://www.foundationmedicine.com/genomic-testing/foundation-one-cdx.
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In
The consolidated revenue in 2017 of
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This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding a collaboration between
1 Global Oncology Trends 2017. Report by the
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