title: Considerations for standardizing predictive molecular pathology for cancer prognosis.
abstract: Molecular tests that were once ancillary to the core business of cyto-histopathology are becoming the most relevant workload in pathology departments after histopathology/cytopathology and before autopsies. This has resulted from innovations in molecular biology techniques, which have developed at an incredibly fast pace. Areas covered: Most of the current widely used techniques in molecular pathology such as FISH, direct sequencing, pyrosequencing, and allele-specific PCR will be replaced by massive parallel sequencing that will not be considered next generation, but rather, will be considered to be current generation sequencing. The pre-analytical steps of molecular techniques such as DNA extraction or sample preparation will be largely automated. Moreover, all the molecular pathology instruments will be part of an integrated workflow that traces the sample from extraction to the analytical steps until the results are reported; these steps will be guided by expert laboratory information systems. In situ hybridization and immunohistochemistry for quantification will be largely digitalized as much as histology will be mostly digitalized rather than viewed using microscopy. Expert commentary: This review summarizes the technical and regulatory issues concerning the standardization of molecular tests in pathology. A vision of the future perspectives of technological changes is also provided.
authors.affiliation: a Pathology Service , Addarii Institute of Oncology, S. Orsola-Malpighi Hospital , Bologna , Italy.
authors.forename: Michelangelo
authors.initials: M
authors.lastname: Fiorentino
authors.affiliation: b Section of Pathological Anatomy , Marche Polytechnic University, School of Medicine, United Hospitals , Ancona , Italy.
authors.forename: Marina
authors.initials: M
authors.lastname: Scarpelli
authors.affiliation: c Department of Surgery , Cordoba University Medical School , Cordoba , Spain.
authors.forename: Antonio
authors.initials: A
authors.lastname: Lopez-Beltran
authors.affiliation: d Department of Pathology and Laboratory Medicine , Indiana University School of Medicine , Indianapolis , IN , USA.
authors.forename: Liang
authors.initials: L
authors.lastname: Cheng
authors.affiliation: a Pathology Service , Addarii Institute of Oncology, S. Orsola-Malpighi Hospital , Bologna , Italy.
authors.forename: Rodolfo
authors.initials: R
authors.lastname: Montironi
mesh_terms: D004273:DNA, Neoplasm / Q000235:genetics*; D006801:Humans; D017404:In Situ Hybridization, Fluorescence / Q000379:methods*; D009369:Neoplasms / Q000175:diagnosis* / Q000235:genetics*; D057089:Pathology, Molecular / Q000379:methods*; D016133:Polymerase Chain Reaction / Q000379:methods*; D011379:Prognosis
chemical_list: D004273:DNA, Neoplasm
keywords: Molecular tests; laboratory automation; molecular pathology; molecular pathology standardization; regulations