FDAで認められているCDx検査のうち、NGSを用いるもの

www.fda.gov

www.fda.gov

１．FoundationOne CDx

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=p170019

Product code: PQP

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

２．Praxis Extended RAS Panel

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=p160038

Product code: PQP

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

３．Oncomine Dx Target Test

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=p160045

Product code: PQP

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

４．FoundationFocus CDxBRCA Assay

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=p160018

Product code: PQP

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

５．Myriad myChoice® CDx

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190014

Product code: PJG

Cancer-Related Germline Gene Mutation Detection System

　　　　　　　　　　　　　　　　　　　　　　　　　　2020年6月7日確認時点