Table 1.
Comprehensive cancer panel sequencing tests | Target | Approval | ||
---|---|---|---|---|
DNA | RNA | Fusion | ||
Oncomine™ Dx Target Test CDx system | 1 (46)a | (46)a | Authorized by PMDA as a CDx for BRAF V600E b | |
NCC OncoPanel | 114 | 13 | The Japanese Advanced Medical Care B program | |
Todai OncoPanel | 465 | 467 | 17 | The Japanese Advanced Medical Care B program |
Oncomine™ Target Test | 46 | 46 | The Japanese Advanced Medical Care B program | |
OncoPrime | 223 | Research | ||
MSK-IMPACT | 468 | 18 | Research | |
PleSSision | 160 | Research | ||
Guardant360 | 73 | Research | ||
CANCERPLEX | 435 | research | ||
ACTOnco+ | 440 | Research | ||
FoundationOne CDx™ | 324 | Research (authorized by FDA as a CDxc) | ||
Oncomine™ Dx Target Test | 23 (46)a | 23 (46)a | Research (authorized by FDA as a CDxd) | |
MSK-IMPACT | 468 | 18 | Research (authorized by FDA as an IVDe) |
aOncomine Dx target test and Oncomine Dx target test CDx system potentially detect alterations in 46 genes
b http://www.info.pmda.go.jp/ygo/pack/840863/23000BZX00089000_A_01_01/
c https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170019A.pdf
d https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160045A.pdf
e https://www.accessdata.fda.gov/cdrh_docs/pdf17/DEN170058.pdf