Targeted therapies with companion diagnostics in the management of breast cancer: current perspectives

Figures & data

Table 1 List of FDA-approved (active and withdrawn) companion diagnostics for use in HER-positive breast cancera

Drug trade name (generic name)	Device trade name	Device manufacturer	PMA number	Original PMA date	Latest PMA dateb	Type of assay
Herceptin (trastuzumab)	INFORM HER2/neu	Ventana Medical Systems, Inc.	P940004	1997	2000 (withdrawn 2007)	Qualitative FISH
	PathVysion HER2 DNA Probe Kit	Abbott Molecular, Inc.	P980024	1998	2014	Qualitative FISH
	PATHWAY anti-HER2/neu (4B5) Rabbit	Ventana Medical Systems, Inc.	P990081	2000	2015	Semiquantitative IHC
	Monoclonal Antibody InSite HER2/neu Kit	Biogenex Laboratories, Inc.	P040030	2004	Withdrawn (2006)	Semiquantitative IHC
	SPOT-Light HER2 CISH Kit	Life Technologies, Inc.	P050040	2008	Withdrawn (2015)	Quantitative CISH
	HER2 CISH pharmDx Kit	Dako Denmark A/S	P100024	2011	2014	Automated, quantitative, dual-color CISH
	INFORM HER2 Dual ISH DNA Probe Cocktail	Ventana Medical Systems, Inc.	P100027	2011	2015	Automated, quantitative, dual-color DISH
	Bond Oracle HER2 IHC System	Leica Biosystems	P090015	2012	2015	Automated, semiquantitative IHC
Herceptin (trastuzumab) Perjeta (pertuzumab)	HercepTest	Dako Denmark A/S	P980018	1998	2013	Semiquantitative IHC
KADCYLA (ado-trastuzumab emtansine)
Herceptin (trastuzumab) Perjeta (pertuzumab)	HER2 IQFISH pharmDx Kit	Dako Denmark A/S	P040005	2005	2013	Quantitative FISH
KADCYLA (ado-trastuzumab emtansine)

Note:

a Data collected from http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ucm301431.htm.⁷⁸

b Updated PMAs were due to changes in manufacturing, product specifications, addition of drugs in the labeling, software, etc.

Abbreviations: CISH, chromogenic in situ hybridization; DISH, dual in situ hybridization; FDA, US Food and Drug Administration; FISH, fluorescent in situ hybridization; HER2, human epidermal growth factor receptor 2; IHC, immunohistochemistry; PMA, premarket approval.

US Food Drug Administration. [webpage on the Internet]List of cleared or approved companion diagnostic devices (in vitro and imaging tools) Available from: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ucm301431.htmAccessed December 22, 2015

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