Foundation Medicine to Present Validation for FoundationOne CDx™, a Comprehensive Genomic Profiling Assay for Advancing Precision Cancer Care
-- Data demonstrated high concordance between FoundationOne CDx and multiple
FoundationOne CDx is a comprehensive genomic profiling (CGP) assay that incorporates multiple companion diagnostics in a single platform with molecular profiling of the 320+ genes known to drive cancer growth. These validation data are also included in the Premarket Approval Application (PMA) for FoundationOne CDx which is currently under review by the
"The landscape of targeted cancer treatments and associated companion diagnostics has grown tremendously in recent years. However, the ability to match tumor-specific molecular information to appropriate treatments is limited by single gene and hot spot panel tests that can exhaust valuable time and tissue," said
Results showed that FoundationOne CDx detected alterations in the EGFR, ALK, BRAF, ERBB2, KRAS and BRCA1/2 genes and demonstrated concordance with
The presentations will take place at the following times:
P2.02-052 -- A clinically-validated universal companion diagnostic platform for cancer patient care,
P3.02-061 -- An ALK follow-on companion diagnostic using CGP for clinical care of patients with NSCLC,
P3.02-062 -- An EGFR follow-on companion diagnostic for clinical care of patients with NSCLC,
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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 ability of FoundationOne CDx to enhance patient access to targeted therapies and clinical trials; the ability of CGP to improve patient outcomes; and the scope and timing of any approval of FoundationOne CDx as a medical device by the
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