FoundationOne® Accepted by FDA and CMS for Parallel Review and FDA Expedited Access Pathway
--Parallel Review of FoundationOne, if Successful, Could Result in FDA Approval of the First Pan-Cancer Comprehensive Genomic Profiling Assay Incorporating a Range of
If approved, FoundationOne could be the first
"The acceptance of FoundationOne for EAP and Parallel Review is a significant advancement towards the achievement of precision medicine, enhancing patient access to targeted therapies and clinical trials," said
FoundationOne is a CGP assay for cancer that uniquely detects genomic alterations, including substitutions, insertions and deletions, copy number alterations and select gene rearrangements in 324 genes using DNA isolated from formalin-fixed paraffin-embedded tumor tissue specimens using next-generation sequencing and computational analysis. It is intended that FoundationOne, if approved, will be used to identify patients who may benefit from treatment for solid tumor malignancies in accordance with
Parallel Review provides for concurrent review of medical devices for
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Foundation Medicine® and FoundationOne® are registered trademarks of
Cautionary Note Regarding Forward-Looking Statements for
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 the scope and timing of any approval of FoundationOne as a medical device by the
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