Current perspectives on HER2 testing: a review of national testing guidelines.
Knowledge of HER2 status is a prerequisite when considering a patient's eligibility for Herceptin (trastuzumab) therapy. Accurate assessment of HER2 status is essential to ensure that all patients who may benefit from Herceptin are correctly identified. There are several assays available to determine HER2 status: the most common in routine clinical practice are immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH). Various factors can affect the results achieved with these assays, including the assay antibody/probe, the methodology and the experience of personnel. Many countries have implemented national testing guidelines in an attempt to standardize testing procedures and make results more accurate. These guidelines vary in the level of detail and the number of recommendations. This review looks at areas of consensus between the different national testing guidelines and highlights where errors may arise during the testing procedure. The key point underlined by this review is that whatever method is used to test for HER2 status, the technology must be validated first, and there must be regular internal and external quality control and quality assurance procedures.
Bilous
Michael
M
Institute of Clinical Pathology and Medical Research, Westmead Hospital, Westmead, New South Wales, Australia.
Dowsett
Mitch
M
Hanna
Wedad
W
Isola
Jorma
J
Lebeau
Annette
A
Moreno
Aberlardo
A
Penault-Llorca
Frédérique
F
Rüschoff
Josef
J
Tomasic
Gorana
G
van de Vijver
Marc
M
D000465:Algorithms; D001943:Breast Neoplasms / Q000175:diagnosis* / Q000235:genetics*; D005820:Genetic Testing / Q000592:standards*; D006287:Health Planning Guidelines; D016591:Histocytological Preparation Techniques / Q000379:methods / Q000592:standards; D006801:Humans; D007150:Immunohistochemistry / Q000379:methods / Q000592:standards; D017404:In Situ Hybridization, Fluorescence; D011786:Quality Control; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000235:genetics*
D018719:Erb-b2 Receptor Tyrosine Kinases