Clinical specimens undergoing diagnostic molecular pathology testing are fixed in formalin due to the necessity for detailed morphological assessment.
In 2008, the French National Institute for Cancer (INCa) initiated a nationwide program for the development of regional platforms for molecular pathology testing for cancers [ 12].
With the recent development and testing of new promising targeted therapies for patients with metastatic melanoma, 139 141 molecular pathology mutation testing for BRAF, NRAS, KIT, and other mutations has become common in many melanoma treatment centers.
Operators for these studies were required to undergo training procedures to demonstrate proficiency, equivalent to what will be used to train users in molecular pathology laboratories for the decentralized test.
As molecular oncology testing becomes more important for prognostic and therapeutic decision making and tissue specimens become smaller due to earlier detection of suspicious lesions and the use of fine needle aspiration methods for tissue collection, it becomes more challenging for the typical molecular pathology laboratory to obtain reliable test results.
HER2 screening in the ToGA study was performed in a central testing laboratory (Targos Molecular Pathology GmbH); it is anticipated that HER2-positivity rates may vary when HER2 testing data are reported from regional centers, further highlighting the need for standardized HER2 testing and scoring and the use of accurate and validated assays [ 14].
In 2013, the College of American Pathologists, International Association for the Study of Lung Cancer, and Association for molecular Pathology established guidelines for the molecular testing of all advanced stage lung adenocarcinomas for EGFR mutations and ALK rearrangements prior to treatment [68].
Cases included in this study were selected from de-identified FFPE tissues that have been previously tested in the Molecular Pathology Laboratory at our institution since October ,2012.
All four participating Molecular Pathology laboratories successfully completed the round robin test of the quality initiative pathology of the German Society of Pathology (Penzel et al, 2011).
