1

PD-L1 IHC 22C3 pharmDx

Dako North America, Inc.

非小细胞肺癌(NSCLC), 胃或胃食管交界处腺癌, 宫颈癌、尿路上皮癌、头颈部鳞状细胞癌 (HNSCC)、食管鳞状细胞癌 (ESCC) 和三阴性乳腺癌 (TNBC)

KEYTRUDA (pembrolizumab) – BLA 125514

Libtayo  (cemiplimab-rwlc) – BLA 761097

2

VENTANA ALK (D5F3) CDx Assay

Ventana Medical Systems, Inc.

非小细胞肺癌

Zykadia (ceritinib) - NDA 205755

Xalkori (crizotinib) - NDA 202570

Alecensa  (alectinib) - NDA 208434

Lorbrena  (lorlatinib) - NDA 210868

3

Dako EGFR  pharmDx Kit

Dako North America, Inc.

大肠癌

Erbitux (cetuximab) - BLA 125084

Vectibix  (panitumumab) - BLA 125147

4

Dako c-KIT pharmDx

Dako North America, Inc.

胃肠道间质瘤

Gleevec (imatinib mesylate) - NDA 021335

Glivec  (imatinib mesylate) - NDA 021588

5

INFORM HER-2/neu

Ventana  Medical Systems, Inc.

乳腺癌

Herceptin (trastuzumab) - BLA 103792

6

PATHWAY  anti-Her2/neu (4B5) Rabbit Monoclonal Primary Antibody

Ventana Medical Systems, Inc.

乳腺癌

Herceptin (trastuzumab) - BLA 103792

Kadcyla  (ado-trastuzumab emtansine) - BLA 125427

7

Bond Oracle HER2 IHC System

Leica Biosystems

乳腺癌

Herceptin  (trastuzumab) - BLA 103792

8

HER2 CISH pharmDx Kit

Dako Denmark A/S

乳腺癌

Herceptin (trastuzumab) - BLA 103792

9

INFORM HER2 Dual ISH DNA Probe Cocktail

Ventana Medical Systems, Inc.

乳腺癌

Herceptin (trastuzumab) - BLA 103792

Kadcyla  (ado-trastuzumab emtansine) - BLA 125427

10

HercepTest

Dako Denmark A/S

乳腺癌

胃癌和胃食管癌

11

HER2 FISH pharmDx Kit

Dako Denmark A/S

乳腺癌

胃癌和胃食管癌

12

VENTANA PD-L1(SP142) Assay

Ventana Medical Systems, Inc.

尿路上皮癌、三阴性乳腺癌 (TNBC) 和非小细胞肺癌 (NSCLC)

TECENTRIQ (atezolizumab) - BLA 761034

13

PD-L1 IHC 28-8 pharmDx

Dako North  America, Inc.

非小细胞肺癌

OPDIVO (nivolumab) (BLA 125554) 联用YERVOY (ipilimumab) (BLA 125377)

14

VENTANA HER2 Dual ISH DNA Probe Cocktail

Ventana Medical Systems, Inc.

乳腺癌

Herceptin (trastuzumab) - BLA 103792

15

VENTANA MMR RxDx Panel

Ventana Medical Systems, Inc.

子宫内膜癌

错配修复缺陷 (dMMR) 实体瘤