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. 2017 Feb 27;10(2):84–92. doi: 10.1111/cts.12455

Table 2.

List of all approved companion and complementary diagnostic assays in the United States

Companion Diagnostic Assays (listed in alphabetic order of drug trade name)
Drug trade name (generic name) Device trade name Disease Platform
1 ERBITUX (cetuximab); VECTIBIX (panitumumab) DAKO EGFR PharmDx Kit Colorectal cancer

  • IHC
2 ERBITUX (cetuximab); VECTIBIX (panitumumab) The cobas KRAS Mutation Test Colorectal cancer

  • PCR
3 ERBITUX (cetuximab); VECTIBIX (panitumumab) therascreen KRAS RGQ PCR Kit Colorectal cancer

  • PCR
4 EXJADE (deferasirox) Ferriscan Thalassemia

  • MRI
5 GILOTRIF (afatinib) therascreen EGFR RGQ PCR Kit Non‐small cell lung cancer

  • PCR
6 GLEEVEC (imatinib mesylate) DAKO C‐KIT PharmDx Gastrointestinal stromal tumor

  • IHC
7 GLEEVEC (imatinib mesylate) PDGFRB FISH for Gleevec Eligibility in Myelodysplastic Syndrome/Myeloproliferative Disease (MDS/MPD) Myelodysplastic Syndrome/Myeloproliferative Disease

  • FISH
8 GLEEVEC (imatinib mesylate) KIT D816V Mutation Detection by PCR for Gleevec Eligibility in Aggressive Systemic Mastocytosis (ASM) Aggressive systemic mastocytosis

  • PCR
9 HERCEPTIN (trastuzumab) INFORM HER‐2/NEU Breast cancer

  • FISH
10 HERCEPTIN (trastuzumab) INSITE HER‐2/NEU KIT Breast cancer

  • IHC
11 HERCEPTIN (trastuzumab) Bond Oracle Her2 IHC System Breast cancer

  • IHC
12 HERCEPTIN (trastuzumab) PATHWAY ANTI‐HER‐2/NEU (4B5) Rabbit Monoclonal Primary Antibody Breast cancer

  • IHC
13 HERCEPTIN (trastuzumab) SPOT‐LIGHT HER2 CISH Kit Breast cancer

  • CISH
14 HERCEPTIN (trastuzumab) PATHVYSION HER‐2 DNA Probe Kit Breast cancer

  • FISH
15 HERCEPTIN (trastuzumab) INFORM HER2 DUAL ISH DNA Probe Cocktail Breast cancer

  • ISH
16 HERCEPTIN (trastuzumab) Bond Oracle Her2 IHC System Breast cancer

  • IHC
17 HERCEPTIN (trastuzumab); PERJETA (pertuzumab); KADCYLA (ado‐trastuzumab emtansine) HERCEPTEST Breast cancer

  • IHC
18 HERCEPTIN (trastuzumab); PERJETA (pertuzumab); KADCYLA (ado‐trastuzumab emtansine) HER2 FISH PharmDx Kit Breast cancer

  • FISH
19 IRESSA(gefitinib) therascreen EGFR RGQ PCR Kit Non‐small cell lung cancer

  • PCR
20 KEYTRUDA (pembrolizumab) PD‐L1 IHC 22C3 PharmDx Non‐small cell lung cancer

  • IHC
21 LYNPARZA (olaparib) BRACAnalysis CDx Ovarian cancer

  • PCR
22 MEKINIST (trametinib); TAFINLAR(dabrafenib) THxID BRAF Kit Melanoma

  • PCR
23 RUBRACA (rucaparib) FoundationFocus CDxBRCA Test Ovarian cancer

  • NGS
24 TAGRISSO (osimertinib) cobas EGFR Mutation Test v2 Non‐small cell lung cancer

  • PCR
25 TARCEVA (erlotinib) cobas EGFR Mutation Test Non‐small cell lung cancer

  • PCR
         
26 VENCLEXTA (venetoclax) VYSIS CLL FISH Probe Kit Chronic lymphocytic leukemia

  • FISH
27 XALKORI (crizotinib) VENTANA ALK (D5F3) CDx Assay Non‐small cell lung cancer

  • IHC
28 XALKORI (crizotinib) VYSIS ALK Break Apart FISH Probe Kit Non‐small cell lung cancer

  • FISH
29 XALKORI (crizotinib) VENTANA ALK (D5F3) CDx Assay Non‐small cell lung cancer

  • IHC
30 ZELBORAF (vemurafenib) COBAS 4800 BRAF V600 Mutation Test Melanoma

  • PCR
Complementary Diagnostic Assays (listed in alphabetic order of drug trade name)
Drug trade name (generic name) Device trade name Disease Assay format
1 OPDIVO (nivolumab) PD‐L1 IHC 28‐8

  • Melanoma

  • Non‐small cell lung cancer

  • IHC
2 TECENTRIQ (atezolizumab) VENTANA PD‐L1 (SP142) Assay

  • Bladder cancer

  • Non‐small cell lung cancer

  • IHC

IHC, Immunohistochemistry; PCR, Real‐time polymerase chain reaction; MRI, Magnetic resonance imaging; FISH, Fluorescence in situ hybridization; ISH, In situ hybridization; CISH, Chromogenic in situ hybridization; NGS, Next‐generation sequencing.