TY - JOUR
T1 - Biomarker testing in oncology - Requirements for organizing external quality assessment programs to improve the performance of laboratory testing
T2 - revision of an expert opinion paper on behalf of IQNPath ABSL
AU - Dufraing, K
AU - Fenizia, F
AU - Torlakovic, E
AU - Wolstenholme, N
AU - Deans, Z C
AU - Rouleau, E
AU - Vyberg, M
AU - Parry, S
AU - Schuuring, E
AU - Dequeker, Elisabeth M C
AU - IQNPath ABSL
PY - 2021/3
Y1 - 2021/3
N2 - In personalized medicine, predictive biomarker testing is the basis for an appropriate choice of therapy for patients with cancer. An important tool for laboratories to ensure accurate results is participation in external quality assurance (EQA) programs. Several providers offer predictive EQA programs for different cancer types, test methods, and sample types. In 2013, a guideline was published on the requirements for organizing high-quality EQA programs in molecular pathology. Now, after six years, steps were taken to further harmonize these EQA programs as an initiative by IQNPath ABSL, an umbrella organization founded by various EQA providers. This revision is based on current knowledge, adds recommendations for programs developed for predictive biomarkers by in situ methodologies (immunohistochemistry and in situ hybridization), and emphasized transparency and an evidence-based approach. In addition, this updated version also has the aim to give an overview of current practices from various EQA providers.
AB - In personalized medicine, predictive biomarker testing is the basis for an appropriate choice of therapy for patients with cancer. An important tool for laboratories to ensure accurate results is participation in external quality assurance (EQA) programs. Several providers offer predictive EQA programs for different cancer types, test methods, and sample types. In 2013, a guideline was published on the requirements for organizing high-quality EQA programs in molecular pathology. Now, after six years, steps were taken to further harmonize these EQA programs as an initiative by IQNPath ABSL, an umbrella organization founded by various EQA providers. This revision is based on current knowledge, adds recommendations for programs developed for predictive biomarkers by in situ methodologies (immunohistochemistry and in situ hybridization), and emphasized transparency and an evidence-based approach. In addition, this updated version also has the aim to give an overview of current practices from various EQA providers.
KW - External quality assessment
KW - Guideline
KW - Immunohistochemistry
KW - In situ hybridization
KW - Molecular pathology
KW - Oncology
KW - Predictive biomarkers
KW - Proficiency testing
UR - http://www.scopus.com/inward/record.url?scp=85092445020&partnerID=8YFLogxK
U2 - 10.1007/s00428-020-02928-z
DO - 10.1007/s00428-020-02928-z
M3 - Journal article
C2 - 33047156
SN - 0945-6317
VL - 478
SP - 553
EP - 565
JO - Virchows Archiv
JF - Virchows Archiv
IS - 3
ER -