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What is FoundationOne ® Liquid CDx Assay?

The FoundationOne ® Liquid CDx assay is a pan-cancer cfDNA-based comprehensive genomic profiling assay that was recently approved by FDA. Validation studies included >7,500 tests and >30,000 unique variants across >300 genes and >30 cancer types. Clinical validity results across multiple tumor types are presented.

Can FoundationOne Liquid CDx Assay identify breast cancer patients with PIK3CA alterations?

The clinical validity of the FoundationOne Liquid CDx assay to identify breast cancer patients harboring PIK3CA alterations eligible for treatment with alpelisib was assessed through retrospective testing of plasma samples.

Where to apply for FoundationOne Liquid CDX PMA?

Product Name: FoundationOne Liquid CDx PMA Applicant: Foundation Medicine, Inc. Address: 150 Second Street, Cambridge, MA 02141 Approval Date: August 26, 2020 Approval Letter: Approval Order.

What is the concordance of FoundationOne Liquid CDX and cfDNA NGS?

Concordance of FoundationOne Liquid CDx and an externally validated cfDNA NGS assay for platform-wide variants (n = 912 positive variants; n = 157,008 negative variants as determined by the comparator assay). Table 9.

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