Atlas FDA

therascreen PIK3CA RGQ PCR Kit

FDA premarket approval P190001 · decided 2019-05-24

Approval details

PMA number
P190001
Trade name
therascreen PIK3CA RGQ PCR Kit
Generic name
Somatic gene mutation detection system
Applicant
QIAGEN GmbH
Date received
2019-01-17
Decision date
2019-05-24
Days to decision
127 days
Decision code
APPR
Product code
OWD
Advisory committee
Medical Genetics
Expedited review
No
Location
Hilden
Statement
Approval for the therascreen PIK3CA RGQ PCR Kit. The therascreen PIK3CA RGQ PCR Kit is a real-time qualitative PCR test for the detection of 11 mutations in the phosphatidylinositol 3-kinase catalytic subunit alpha (PIK3CA) gene (Exon 7: C420R; Exon 9: E542K, E545A, E545D [1635G>T only], E545G, E545K, Q546E, Q546R; and Exon 20: H1047L, H1047R, H1047Y) using genomic DNA (gDNA) extracted from formalin-fixed, paraffin-embedded (FFPE) breast tumor tissue or circulating tumor DNA (ctDNA) from plasma

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