The International Society for Immunohistochemistry and Molecular Morphology (ISIMM)

Following a lengthy gestation “The International Society for Immunohistochemistry and Molecular Morphology” (ISIMM) was founded in March 2016, during the week of the USCAP meeting in Seattle. The major driving “force” behind this effort was an initiative of the external quality control and assurance agencies NordiQC, CIQC, UKNEQAS, IQNPath1 (and others) and editorial board members of AIMM, the affiliated journal of the new society. As part of the foundation process the existing Society for Applied Immunohistochemistry agreed to merge its activities and its members into ISIMM. The mission statement is as follows:The Society will promote knowledge, innovation and excellence in slide-based techniques such as immunohistochemistry and in situ hybridization. The Society seeks to increase knowledge of methods, applications, and limitations of these slide based techniques, and to provide leadership and education in the form of seminars, publications, and best practice guidelines with the overarching goal of improving patient care. IMMUNOHISTOCHEMISTRY (IHC) AS A “STAIN” The founding, in 2016, of a new society devoted to IHC and allied methods may at first sight seem to be unduly delayed, considering that the first reports of the use of an IHC method on routine formalin-fixed paraffin-embedded (FFPE) tissues appeared some 40 years earlier.2 The original immunoperoxidase method was rapidly adapted and adopted as evidenced by an exponential increase in publications over the next 2 decades. The focus of those early works was upon ways of increasing the analytical sensitivity and adding to the number of useful antibodies, thereby expanding the range of antigens (proteins, biomarkers) that are detectable in FFPE tissues. The result was a laboratory menu that listed initially tens, and eventually hundreds, of IHC “stains,” with a correspondingly enormous literature pertaining to diagnostic application and utility. If the success of the IHC method is to be measured by the number of available IHC stains, their penetration into the literature and the standard textbooks, and into diagnostic practice, then the method must be judged a resounding success. However, throughout this period IHC was used in much the same manner as any biological or special stain—to impart differential color to tissue and cell components as an aid to cellular recognition. In short, IHC was utilized as a form of stain, and like most stains was purely qualitative in performance and interpretation—either positive or negative. IHC AS AN “ASSAY” In the 1990s, with the demonstration of estrogen and progesterone receptors in FFPE tissue sections, there emerged a new use for IHC, not just as a stain, but as the beginning of a tissue based assay that purported to provide some form of (semi)quantitative result, having prognostic or predictive value. In 1998 this new emphasis gained a sudden powerful impetus with the approval by the FDA of what was essentially the first IHC “Companion Diagnostic,” the HercepTest, as a classifier of responders versus nonresponders for the targeted therapy Herceptin (directed against HER2) (http://www.dako.com/herceptest; http://www.herceptin.com). Other similar tests followed (against the same and other targets). With their use came recognition that the standard approaches and (bad) habits adopted in the performance of IHC, while perhaps adequate for traditional employment as a qualitative stain, fell far short when applied to the purpose of companion diagnostics, which require higher orders of accuracy and reproducibility, plus validated quantification, extending beyond current “IHC scoring approaches,” which are difficult to teach, difficult to learn, and semiquantitative at best. In the past decade the external quality assurance organizations have found ample evidence of the challenges that these new demands place upon the basic IHC method, and of the shortfalls at many levels, including sample preparation, validation of reagents, assay performance, selection of control materials, as well interpretation and reproducibility of the end result.1 THE ROLE OF ISIMM The development and dissemination of “best practice” approaches to biomarker testing of both IHC and ISH has shown evidence of improved performance at local levels, with greater reliability and reproducibility of results in general.1,3–6 At the same time it has uncovered a pressing need for improved communication, not just between vendors and users of these methods but across laboratories and international borders, and for the creation of an active forum wherein these issues can be presented, analyzed, discussed, and ultimately put into practice universally. It is to meet these needs that ISIMM was formed. The Society plans to hold annual business meetings and conduct seminars and other activities in conjunction with the meetings of USCAP (2017, San Antonio, TX) and the International Academy of Pathology, European and Asian-Pacific Branches (Amsterdam and Bali in 2017—agreement already in place for APIAP Bali in April 2017 http://apiap2017.com). It is the intent of the founders that these meetings will include both education components and member meetings to further shape the operations, committees, and activities of ISIMM. Membership is open to all individuals with an active interest in IHC or ISH and related tissue-based methods, through the Society’s website—http://www.ISIMM.org, to which the reader is referred for further information and for membership application. The initial annual subscription for “Founder Members” has been set at $100.00 US (or equivalent through Paypal), a rate that includes the cost of online subscription to AIMM, as the affiliated journal. A category has also been created for membership and participation by organizations, including corporations, with interests or activities in this field. The initial operative Bylaws of ISMM may be accessed at: http://www.ISIMM.org, and the offices of the Society may be contacted at: [email protected]. Clive R. Taylor (President), Mogens Vyberg (Vice President, President Elect), Allen M. Gown (Vice President Elect), Regan Fulton (Secretary-Treasurer), Richard Cartun, Richard N. Eisen (Society for Applied Immunohistochemistry), Blake Gilks, Emina E. Torlakovics (Canadian Immunohistochemistry Quality Control), Søren Nielsen (NordiQC), Paul Swanson (formerly of CAP IHC Committee).

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