Comparison of Tissue Molecular Biomarker Testing Turnaround Times and Concordance Between Standard of Care and the Biocartis Idylla Platform in Patients With Colorectal Cancer

Authors

Gregory J. Tsongalis, Clinical Genomics and Advanced Technology (CGAT) Laboratory, Department of Pathology and Laboratory Medicine, Dartmouth Hitchcock Health System, Lebanon, NH Geisel School of Medicine at Dartmouth, Hanover, NH
M Rabie Al Turkmani, Clinical Genomics and Advanced Technology (CGAT) Laboratory, Department of Pathology and Laboratory Medicine, Dartmouth Hitchcock Health System, Lebanon, NH Geisel School of Medicine at Dartmouth, Hanover, NH
Michael Suriawinata, Clinical Genomics and Advanced Technology (CGAT) Laboratory, Department of Pathology and Laboratory Medicine, Dartmouth Hitchcock Health System, Lebanon, NH Geisel School of Medicine at Dartmouth, Hanover, NH
Michael J. Babcock, Bioinformatics & Molecular Pathology, Dahl-Chase Diagnostic Services & Pathology Associates, Bangor, ME
Kristi Mitchell, Bioinformatics & Molecular Pathology, Dahl-Chase Diagnostic Services & Pathology Associates, Bangor, ME
Yi Ding, Diagnostic Medicine Institute, Geisinger Medical Center, Danville, PA
Lisa Scicchitano, Diagnostic Medicine Institute, Geisinger Medical Center, Danville, PA
Adrian Tira, Department of Pathology, Rush University Medical Center, Chicago, IL
Lela Buckingham, Department of Pathology, Rush University Medical Center, Chicago, IL
Sara Atkinson, Department of Cytology, Cone Health Moses Cone Hospital, Greensboro, NC
Amy Lax, Department of Cytology, Cone Health Moses Cone Hospital, Greensboro, NC
Dara L. Aisner, Colorado Molecular Correlates Laboratory (CMOCO), Department of Pathology, University of Colorado Anschutz Medical Campus, Aurora
Kurtis D. Davies, Colorado Molecular Correlates Laboratory (CMOCO), Department of Pathology, University of Colorado Anschutz Medical Campus, Aurora
Holly N. Wood, Colorado Molecular Correlates Laboratory (CMOCO), Department of Pathology, University of Colorado Anschutz Medical Campus, Aurora
Stacey S. O'Neill, Department of Pathology, Wake Forest School of Medicine, Winston-Salem, NC
Edward A. Levine, Division of Surgical Oncology, Department of Surgery, Wake Forest School of Medicine, Winston-Salem, NC.
Judy Sequeira, Department of Pathology and Laboratory Medicine, Comprehensive Care and Research Center, Cancer Treatment Centers of America Atlanta, Newnan, GA
Shuko Harada, Molecular Diagnostics Laboratory, Department of Pathology, University of Alabama Birmingham School of Medicine, Birmingham
Gina DeFrank, Molecular Diagnostics Laboratory, Department of Pathology, University of Alabama Birmingham School of Medicine, Birmingham
Ravikumar Paluri, Department of Medicine, Division of Hematology/Oncology, University of Alabama Birmingham School of Medicine, Birmingham
Bradford A. Tan, Department of Pathology and Laboratory Medicine, Comprehensive Care and Research Center, Cancer Treatment Centers of America Chicago, Zion, IL
Heather Colabella, Department of Pathology and Laboratory Medicine, Comprehensive Care and Research Center, Cancer Treatment Centers of America Chicago, Zion, IL
Christopher Snead, CHRISTUS Cancer Treatment Center, Shreveport, LA
Marcia Cruz-Correa, Pan American Center for Oncology Trials, Oncologic Hospital, Puerto Rico Medical Center, Rio Piedras, Puerto Rico
Virginia Ramirez, Pan American Center for Oncology Trials, Oncologic Hospital, Puerto Rico Medical Center, Rio Piedras, Puerto Rico
Arnaldo Rojas, Pan American Center for Oncology Trials, Oncologic Hospital, Puerto Rico Medical Center, Rio Piedras, Puerto Rico
Huiya Huang, Department of Pathology, Medical College of Wisconsin, Milwaukee
Alexander C. Mackinnon, Department of Pathology, Medical College of Wisconsin, Milwaukee
Fernando U. Garcia, Department of Pathology and Laboratory Medicine, Comprehensive Care and Research Center, Cancer Treatment Centers of America Philadelphia, Philadelphia, PA
Sharon M. Cavone, Department of Pathology and Laboratory Medicine, Comprehensive Care and Research Center, Cancer Treatment Centers of America Philadelphia, Philadelphia, PA
Mutasim Elfahal, Department of Pathology and Laboratory Medicine, Lahey Hospital and Medical Center, Beth Israel Lahey Health, Burlington, MA
Gyorgy Abel, Department of Pathology and Laboratory Medicine, Lahey Hospital and Medical Center, Beth Israel Lahey Health, Burlington, MA
Mohammad A. Vasef, Department of Pathology, University of New Mexico Health Sciences Center, Albuquerque
Andrew Judd, Department of Pathology, University of New Mexico Health Sciences Center, Albuquerque
Mark W. Linder, Department of Pathology and Laboratory Medicine, University of Louisville Hospital, Louisville, KY
Khaled Alkhateeb, Department of Pathology and Laboratory Medicine, University of Louisville Hospital, Louisville, KY
William L. Skinner, Mercy Health-Paducah Medical Oncology and Hematology, Paducah, KY
Ralph Boccia, The Center for Cancer and Blood Disorders, Bethesda, MD
Kashyap Patel, Carolina Blood and Cancer Care Associates, PA, Rock Hill, SC

Document Type

Article

Publication Date

7-7-2020

Abstract

OBJECTIVES: Management of colorectal cancer warrants mutational analysis of KRAS/NRAS when considering anti-epidermal growth factor receptor therapy and BRAF testing for prognostic stratification. In this multicenter study, we compared a fully integrated, cartridge-based system to standard-of-care assays used by participating laboratories.

METHODS: Twenty laboratories enrolled 874 colorectal cancer cases between November 2017 and December 2018. Testing was performed on the Idylla automated system (Biocartis) using the KRAS and NRAS-BRAF cartridges (research use only) and results compared with in-house standard-of-care testing methods.

RESULTS: There were sufficient data on 780 cases to measure turnaround time compared with standard assays. In-house polymerase chain reaction (PCR) had an average testing turnaround time of 5.6 days, send-out PCR of 22.5 days, in-house Sanger sequencing of 14.7 days, send-out Sanger of 17.8 days, in-house next-generation sequencing (NGS) of 12.5 days, and send-out NGS of 20.0 days. Standard testing had an average turnaround time of 11 days. Idylla average time to results was 4.9 days with a range of 0.4 to 13.5 days.

CONCLUSIONS: The described cartridge-based system offers rapid and reliable testing of clinically actionable mutation in colorectal cancer specimens directly from formalin-fixed, paraffin-embedded tissue sections. Its simplicity and ease of use compared with other molecular techniques make it suitable for routine clinical laboratory testing.

Recommended Citation

Tsongalis GJ, Al Turkmani MR, Suriawinata M, Babcock MJ, Mitchell K, Ding Y, Scicchitano L, Tira A, Buckingham L, Atkinson S, Lax A, Aisner DL, Davies KD, Wood HN, O'Neill SS, Levine EA, Sequeira J, Harada S, DeFrank G, Paluri R, Tan BA, Colabella H, Snead C, Cruz-Correa M, Ramirez V, Rojas A, Huang H, Mackinnon AC, Garcia FU, Cavone SM, Elfahal M, Abel G, Vasef MA, Judd A, Linder MW, Alkhateeb K, Skinner WL, Boccia R, Patel K. Comparison of Tissue Molecular Biomarker Testing Turnaround Times and Concordance Between Standard of Care and the Biocartis Idylla Platform in Patients With Colorectal Cancer. Am J Clin Pathol. 2020 Jul 7;154(2):266-276. doi: 10.1093/ajcp/aqaa044. PMID: 32525522.