PMID- 34050358
OWN - NLM
STAT- MEDLINE
DCOM- 20211109
LR  - 20211109
IS  - 1943-7722 (Electronic)
IS  - 0002-9173 (Print)
IS  - 0002-9173 (Linking)
VI  - 156
IP  - 5
DP  - 2021 Oct 13
TI  - Use of the Xpert Breast Cancer STRAT4 for Biomarker Evaluation in Tissue 
      Processed in a Developing Country.
PG  - 766-776
LID - 10.1093/ajcp/aqab016 [doi]
AB  - OBJECTIVES: Breast cancer immunohistochemistry (IHC) biomarker testing is limited 
      in low-resource settings, and an alternative solution is needed. A point-of-care 
      mRNA STRAT4 breast cancer assay for ESR1, PGR, ERBB2, and MKi67, for use on the 
      GeneXpert platform, has been recently validated on tissues from internationally 
      accredited laboratories, showing excellent concordance with IHC. METHODS: We 
      evaluated STRAT4/IHC ESR1/estrogen receptor (ER), ERBB2/human epidermal growth 
      factor receptor 2 (HER2) concordance rates of 150 breast cancer tissues processed 
      in Rwanda, with undocumented cold ischemic and fixation time. RESULTS: Assay 
      fail/indeterminate rate was 2.6% for ESR1 and ERBB2. STRAT4 agreement with ER IHC 
      was 92.5% to 93.3% and 97.8% for HER2, for standard (1x) and concentrated (4x) 
      reagent-conserving protocols, respectively. Eleven of 12 discordant ER/ESR1 cases 
      were ESR1- negative/IHC-positive. These had low expression of ER by IHC in mostly 
      very small tumor areas tested (7/12; <25 mm2). In two of three discordant HER2 
      cases, the STRAT4-ERBB2 result correlated with the subsequent fluorescence in 
      situ hybridization (FISH) result. STRAT4-ERBB2 results in 9 of 10 HER2-IHC 
      equivocal cases were concordant with FISH. CONCLUSIONS: The STRAT4 assay is an 
      alternative for providing quality-controlled breast cancer biomarker data in 
      laboratories unable to provide quality and/or cost-efficient IHC services.
CI  - (c) American Society for Clinical Pathology, 2021.
FAU - Mugabe, Marcellin
AU  - Mugabe M
AD  - Windhoek Central Hospital, Windhoek, Namibia.
FAU - Ho, Kenneth E
AU  - Ho KE
AD  - Division of Oncology Research & Development, Cepheid, Sunnyvale, CA, USA.
FAU - Ruhangaza, Deo
AU  - Ruhangaza D
AD  - Butaro Cancer Center of Excellence, Butaro, Rwanda.
FAU - Milner, Dan
AU  - Milner D
AD  - American Society for Clinical Pathology, Chicago, IL, USA.
FAU - Rugwizangoga, Belson
AU  - Rugwizangoga B
AUID- ORCID: 0000-0001-6941-7320
AD  - University of Rwanda, School of Medicine and Pharmacy, Kigali, Rwanda.
FAU - Chu, Victor C
AU  - Chu VC
AD  - Division of Oncology Research & Development, Cepheid, Sunnyvale, CA, USA.
FAU - Wu, Natalie C
AU  - Wu NC
AD  - Division of Oncology Research & Development, Cepheid, Sunnyvale, CA, USA.
FAU - Rizo, Annaliza
AU  - Rizo A
AD  - Division of Oncology Research & Development, Cepheid, Sunnyvale, CA, USA.
FAU - Weidler, Jodi M
AU  - Weidler JM
AD  - Division of Oncology Research & Development, Cepheid, Sunnyvale, CA, USA.
FAU - Wong, Wendy
AU  - Wong W
AD  - Division of Oncology Research & Development, Cepheid, Sunnyvale, CA, USA.
FAU - Bates, Michael
AU  - Bates M
AD  - Division of Oncology Research & Development, Cepheid, Sunnyvale, CA, USA.
FAU - Brock, Jane E
AU  - Brock JE
AD  - Department of Pathology, Brigham and Women's Hospital, Boston, MA, USA.
LA  - eng
PT  - Journal Article
PL  - England
TA  - Am J Clin Pathol
JT  - American journal of clinical pathology
JID - 0370470
RN  - 0 (Biomarkers, Tumor)
RN  - 0 (RNA, Messenger)
SB  - IM
MH  - Biomarkers, Tumor/*analysis
MH  - Breast Neoplasms/*diagnosis
MH  - Developing Countries
MH  - Female
MH  - Humans
MH  - Multiplex Polymerase Chain Reaction/*methods
MH  - RNA, Messenger/*analysis
MH  - Rwanda
PMC - PMC8512210
OTO - NOTNLM
OT  - ERBB2
OT  - ESR1
OT  - Breast cancer assays
OT  - Estrogen receptor
OT  - GeneXpert
OT  - Human epidermal growth factor receptor 2
OT  - LMIC
OT  - STRAT4
OT  - mRNA
EDAT- 2021/05/30 06:00
MHDA- 2021/11/10 06:00
PMCR- 2021/05/29
CRDT- 2021/05/29 06:16
PHST- 2021/05/30 06:00 [pubmed]
PHST- 2021/11/10 06:00 [medline]
PHST- 2021/05/29 06:16 [entrez]
PHST- 2021/05/29 00:00 [pmc-release]
AID - 6288023 [pii]
AID - aqab016 [pii]
AID - 10.1093/ajcp/aqab016 [doi]
PST - ppublish
SO  - Am J Clin Pathol. 2021 Oct 13;156(5):766-776. doi: 10.1093/ajcp/aqab016.