Comparison of Tissue Molecular Biomarker Testing Turnaround Times and Concordance Between Standard of Care and the Biocartis Idylla Platform in Patients With Colorectal Cancer
Year: 2020
Type: article
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.
DOI: 10.1093/ajcp/aqaa044
Authors: Gregory J Tsongalis, M Rabie Al Turkmani, Michael Suriawinata, Michael J Babcock, Kristi Mitchell, Yi Ding, Lisa Scicchitano, Adrian Tira, Lela Buckingham, Sara Atkinson, Amy Lax, Dara L Aisner, Kurtis D Davies, Holly N Wood, Stacey S O’Neill, Edward A Levine, Judy Sequeira, Shuko Harada, Gina DeFrank, Ravikumar Paluri, Bradford A Tan, Heather Colabella, Christopher Snead, Marcia Cruz-Correa, Virginia Ramirez, Arnaldo Rojas, Huiya Huang, Alexander C Mackinnon, Fernando U Garcia, Sharon M Cavone, Mutasim Elfahal, Gyorgy Abel, Mohammad A Vasef, Andrew Judd, Mark W Linder, Khaled Alkhateeb, William L Skinner, Ralph Boccia, Kashyap Patel
Institutions: Dartmouth College, Dartmouth–Hitchcock Medical Center, Geisinger Medical Center, Rush University Medical Center, Cone Health, Moses H Cone Memorial Hospital, University of Colorado Anschutz, Wake Forest University Health Sciences, Wake Forest University, Cancer Treatment Centers of America, University of Alabama at Birmingham, UAB Medicine, CHRISTUS Highland Medical Center, Medical College of Wisconsin, Lahey Hospital and Medical Center, Lahey Medical Center, University of New Mexico Health Sciences Center, University of Louisville Hospital, Mercy Health, Center for Cancers and Blood Disorders
Language: English
Subfield: Oncology
Field: Medicine
Domain: Health Sciences
Open Access status: green
Award: Cancer Center Support Grant
OpenAlex ID: W3033078319