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MEDICINE







          In summary, it may be time to replace ratio reporting with sin-  cancers submitted for FISH testing: experience of a reference
        gle-probe ISH, and to categorize breast tumors with average HER2  laboratory using US Food and Drug Administration criteria and
        gene copy number <6 and 1-2+ protein expression as HER2-low.  American Society of Clinical Oncology and College of American
        Recognizing this distinct genomic subtype on pathology reports will  Pathologists Guidelines. J Clin Oncol. 2016;34(29):3502-3510.
                                                                 doi: 10.1200/ JCO.2015.61.8983.
        give a clinician critical information about a patient’s HER2 biology,
        while saving time and healthcare dollars that are currently being
                                                               6. Chin SF, Wang Y, Thorne NP, et al. Using array-comparative ge-
        spent trying to transform HER2-low tumors into those that can be  nomic hybridization to define molecular portraits of primary
        definitively called HER2-positive or HER2-negative.      breast cancers. Oncogene. 2007;26(13):1959-1970.
          We must await the results of the NSABP-B47 trial for guidance
        as to how to best treat this subset of high-risk patients, but to rec-  7. Yeh IT, Martin MA, Robetorye RS, et al. Clinical validation of
        ognize this genomic subtype now would at least identify the HER2-  an array CGH test for HER2 status in breast cancer reveals that
        low tumors and “give them their seat at the table,” as one of my  polysomy 17 is a rare event. Mod Pathol. 2009;22(9):1169-1175.
                                                                 doi: 10.1038/modpathol.2009.78.
        pathology colleagues has eloquently stated.
        Affiliations: Targeted Genomics and Precision          8. Gunn S, Yeh IT, Lytvak I, et al. Clinical array-based karyotyping
                                                                 of breast cancer with equivocal HER2 status resolves gene copy
        Pathology Services, San Antonio, Texas.
                                                                 number and reveals chromosome 17 complexity. BMC Cancer.
          Send correspondence to: Shelly Gunn, MD, PhD, Targeted Ge-  2010;10:396.   doi:  10.1186/1471-2407-10-396.
        nomics and Precision Pathology Services, 711 Navarro St, Ste 406,
        San Antonio, TX 78209. E-mail: gunns@targeted-genomics.com.  9. Hansen TV, Vikesaa J, Buhl SS, et al. High-density SNP arrays
        Disclosures: Dr Gunn discloses that she has been a speaker for  improve detection of HER2 amplification and polyploidy in
        Roche/Genentech.                                         breast tumors. BMC Cancer. 2015;15:35. doi: 10.1186/s12885-
                                                                 015-1035-1.
        References
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        4. Wolff AC, Hammond ME, Hicks DG, et al; American Society  13. Ross JS, Muraca PJ, Jaffe D, et al. Multivariate analysis of prog-
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        5. Shah MV, Wiktor AE, Meyer RG, et al. Change in pattern of  15. Press MF, Sauter G, Buyse M, et al. HER2 gene amplification
          HER2 fluorescent in situ hybridization (FISH) results in breast  testing by fluorescent in situ hybridization (FISH): comparison
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