PMID- 22200084 OWN - NLM STAT- MEDLINE DCOM- 20120209 LR - 20171116 IS - 2210-7762 (Print) VI - 204 IP - 11 DP - 2011 Nov TI - FISH-based determination of HER2 status in circulating tumor cells isolated with the microfluidic CEE platform. PG - 589-95 LID - 10.1016/j.cancergen.2011.10.011 [doi] AB - Determination of HER2 status in breast cancer patients is considered standard practice for therapy selection. However, tumor biopsy in patients with recurrent and/or metastatic disease is not always feasible. Thus, circulating tumor cells (CTCs) are an alternative source of tumor cells for analysis of HER2. An antibody cocktail for recovery of variable, high- and low-, EpCAM-expressing tumor cells was developed based on FACS evaluation and then verified by CTC enumeration (based on CK and CD45 staining) with comparison to EpCAM-only and with CellSearch(R) (n=19). HER2 fluorescence in situ hybridization (FISH) on all (CK+ and CK-) captured cells was compared to HER2 status on the primary tumors (n=54) of patients with late stage metastatic/recurrent breast cancer. Capture of low EpCAM-expressing tumor cells increased from 27% to 76% when using the cocktail versus EpCAM alone, respectively. Overall, CTC detection with the OncoCEE platform was better compared to CellSearch(R) (68% vs. 89%, respectively), and a 93% concordance in HER2 status was observed. HER2 FISH analysis of CK+ and CK- CTCs is feasible using the CEE platform. Although larger clinical studies are warranted, the results demonstrate adequate sensitivity and specificity as needed for incorporation into laboratory testing. CI - Copyright (c) 2011 Elsevier Inc. All rights reserved. FAU - Mayer, Julie Ann AU - Mayer JA AD - Biocept Inc., San Diego, CA, USA. FAU - Pham, Tam AU - Pham T FAU - Wong, Karina L AU - Wong KL FAU - Scoggin, Jayne AU - Scoggin J FAU - Sales, Edgar V AU - Sales EV FAU - Clarin, Trisky AU - Clarin T FAU - Pircher, Tony J AU - Pircher TJ FAU - Mikolajczyk, Stephen D AU - Mikolajczyk SD FAU - Cotter, Philip D AU - Cotter PD FAU - Bischoff, Farideh Z AU - Bischoff FZ LA - eng PT - Comparative Study PT - Journal Article PL - United States TA - Cancer Genet JT - Cancer genetics JID - 101539150 RN - EC 2.7.10.1 (ERBB2 protein, human) RN - EC 2.7.10.1 (Receptor, ErbB-2) RN - EC 2.7.3.2 (Creatine Kinase) RN - EC 3.1.3.48 (Leukocyte Common Antigens) RN - EC 3.1.3.48 (PTPRC protein, human) SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Breast Neoplasms/*pathology MH - Cell Separation/*methods MH - Creatine Kinase/blood MH - Female MH - Humans MH - In Situ Hybridization, Fluorescence/*methods MH - Leukocyte Common Antigens/blood MH - Microfluidic Analytical Techniques/*methods MH - Middle Aged MH - Neoplastic Cells, Circulating/*chemistry MH - Receptor, ErbB-2/*blood EDAT- 2011/12/28 06:00 MHDA- 2012/02/10 06:00 CRDT- 2011/12/28 06:00 PHST- 2011/08/09 00:00 [received] PHST- 2011/10/21 00:00 [revised] PHST- 2011/10/24 00:00 [accepted] PHST- 2011/12/28 06:00 [entrez] PHST- 2011/12/28 06:00 [pubmed] PHST- 2012/02/10 06:00 [medline] AID - S2210-7762(11)00304-8 [pii] AID - 10.1016/j.cancergen.2011.10.011 [doi] PST - ppublish SO - Cancer Genet. 2011 Nov;204(11):589-95. doi: 10.1016/j.cancergen.2011.10.011.