FoundationOne Liquid CDx
FDA premarket approval P200016 · decided 2020-11-06
Approval details
- PMA number
- P200016
- Trade name
- FoundationOne Liquid CDx
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Foundation Medicine, Inc.
- Date received
- 2020-03-09
- Decision date
- 2020-11-06
- Days to decision
- 242 days
- Decision code
- APCB
- Product code
- PQP
- Advisory committee
- Medical Genetics
- Expedited review
- No
- Location
- Cambridge, MA
- Statement
- Approval for the FoundationOne® Liquid CDx is a qualitative next generation sequencing based in vitro diagnostic test that uses targeted high throughput hybridization-based capture technology to detect and report substitutions, insertions and deletions (indels) in 311 genes, including rearrangements in four (4) genes, and copy number alterations in three (3) genes. FoundationOne® Liquid CDx utilizes circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral wh
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