PMID- 20660336
OWN - NLM
STAT- MEDLINE
DCOM- 20100820
LR  - 20141120
IS  - 1943-7722 (Electronic)
IS  - 0002-9173 (Linking)
VI  - 134
IP  - 2
DP  - 2010 Aug
TI  - Comparison of central HER2 testing with quantitative total HER2 expression and 
      HER2 homodimer measurements using a novel proximity-based assay.
PG  - 303-11
LID - 10.1309/AJCP3BZY4YAFNTRG [doi]
AB  - The accuracy and reliability of immunohistochemical analysis and in situ 
      hybridization for the assessment of HER2 status remains a subject of debate. We 
      developed a novel assay (HERmark Breast Cancer Assay, Monogram Biosciences, South 
      San Francisco, CA) that provides precise quantification of total HER2 protein 
      expression (H2T) and HER2 homodimers (H2D) in formalin-fixed, paraffin-embedded 
      tissue specimens. H2T and H2D results of 237 breast cancers were compared with 
      those of immunohistochemical studies and fluorescence in situ hybridization 
      (FISH) centrally performed at the Mayo Clinic, Rochester, MN. H2T described a 
      continuum across a wide dynamic range ( approximately 2.5 log). Excluding the 
      equivocal cases, HERmark showed 98% concordance with immunohistochemical studies 
      for positive and negative assay values. For the 94 immunohistochemically 
      equivocal cases, 67% and 39% concordance values were observed between HERmark and 
      FISH for positive and negative assay values, respectively. Polysomy 17 in the 
      absence of HER2 gene amplification did not result in HER2 overexpression as 
      evaluated quantitatively using the HERmark assay.
FAU - Huang, Weidong
AU  - Huang W
AD  - Dept. of Clinical Research, Monogram Biosciences, South San Francisco, CA 94080, 
      USA.
FAU - Reinholz, Monica
AU  - Reinholz M
FAU - Weidler, Jodi
AU  - Weidler J
FAU - Yolanda, Lie
AU  - Yolanda L
FAU - Paquet, Agnes
AU  - Paquet A
FAU - Whitcomb, Jeannette
AU  - Whitcomb J
FAU - Lingle, Wilma
AU  - Lingle W
FAU - Jenkins, Robert B
AU  - Jenkins RB
FAU - Chen, Beiyun
AU  - Chen B
FAU - Larson, Jeffrey S
AU  - Larson JS
FAU - Tan, Yuping
AU  - Tan Y
FAU - Sherwood, Thomas
AU  - Sherwood T
FAU - Bates, Michael
AU  - Bates M
FAU - Perez, Edith A
AU  - Perez EA
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PL  - England
TA  - Am J Clin Pathol
JT  - American journal of clinical pathology
JID - 0370470
RN  - EC 2.7.10.1 (Receptor, ErbB-2)
SB  - IM
MH  - Breast Neoplasms/*genetics/metabolism
MH  - Female
MH  - Fluorescent Antibody Technique/*methods
MH  - Humans
MH  - Immunohistochemistry
MH  - In Situ Hybridization, Fluorescence
MH  - Receptor, ErbB-2/*analysis/biosynthesis/genetics
MH  - Reproducibility of Results
EDAT- 2010/07/28 06:00
MHDA- 2010/08/21 06:00
CRDT- 2010/07/28 06:00
PHST- 2010/07/28 06:00 [entrez]
PHST- 2010/07/28 06:00 [pubmed]
PHST- 2010/08/21 06:00 [medline]
AID - 134/2/303 [pii]
AID - 10.1309/AJCP3BZY4YAFNTRG [doi]
PST - ppublish
SO  - Am J Clin Pathol. 2010 Aug;134(2):303-11. doi: 10.1309/AJCP3BZY4YAFNTRG.