Evidence map›Paper›PMID 32525522›Full record

ArticleAmerican journal of clinical pathology2020

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

Gregory J Tsongalis, M Rabie Al Turkmani, Michael Suriawinata, Michael J Babcock, Kristi Mitchell, Yi Ding, Lisa Scicchitano, Adrian Tira, Lela Buckingham, Sara Atkinson and 29 more

Abstract read
In one paragraph

Article in American journal of clinical pathology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

39 authors.

Gregory J TsongalisClinical Genomics and Advanced Technology (CGAT) Laboratory, Department of Pathology and Laboratory Medicine, Dartmouth Hitchcock Health System, Lebanon, NH.
M Rabie Al TurkmaniClinical Genomics and Advanced Technology (CGAT) Laboratory, Department of Pathology and Laboratory Medicine, Dartmouth Hitchcock Health System, Lebanon, NH.
Michael SuriawinataClinical Genomics and Advanced Technology (CGAT) Laboratory, Department of Pathology and Laboratory Medicine, Dartmouth Hitchcock Health System, Lebanon, NH.
Michael J BabcockBioinformatics & Molecular Pathology, Dahl-Chase Diagnostic Services & Pathology Associates, Bangor, ME.
Kristi MitchellBioinformatics & Molecular Pathology, Dahl-Chase Diagnostic Services & Pathology Associates, Bangor, ME.
Yi DingDiagnostic Medicine Institute, Geisinger Medical Center, Danville, PA.
Lisa ScicchitanoDiagnostic Medicine Institute, Geisinger Medical Center, Danville, PA.
Adrian TiraDepartment of Pathology, Rush University Medical Center, Chicago, IL.
Lela BuckinghamDepartment of Pathology, Rush University Medical Center, Chicago, IL.
Sara AtkinsonDepartment of Cytology, Cone Health Moses Cone Hospital, Greensboro, NC.
Amy LaxDepartment of Cytology, Cone Health Moses Cone Hospital, Greensboro, NC.
Dara L AisnerColorado Molecular Correlates Laboratory (CMOCO), Department of Pathology, University of Colorado Anschutz Medical Campus, Aurora.
Kurtis D DaviesColorado Molecular Correlates Laboratory (CMOCO), Department of Pathology, University of Colorado Anschutz Medical Campus, Aurora.
Holly N WoodColorado Molecular Correlates Laboratory (CMOCO), Department of Pathology, University of Colorado Anschutz Medical Campus, Aurora.
Stacey S O'NeillDepartment of Pathology, Wake Forest School of Medicine, Winston-Salem, NC.
Edward A LevineDivision of Surgical Oncology, Department of Surgery, Wake Forest School of Medicine, Winston-Salem, NC.
Judy SequeiraDepartment of Pathology and Laboratory Medicine, Comprehensive Care and Research Center, Cancer Treatment Centers of America Atlanta, Newnan, GA.
Shuko HaradaMolecular Diagnostics Laboratory, Department of Pathology, University of Alabama Birmingham School of Medicine, Birmingham.
Gina DeFrankMolecular Diagnostics Laboratory, Department of Pathology, University of Alabama Birmingham School of Medicine, Birmingham.
Ravikumar PaluriDepartment of Medicine, Division of Hematology/Oncology, University of Alabama Birmingham School of Medicine, Birmingham.
Bradford A TanDepartment of Pathology and Laboratory Medicine, Comprehensive Care and Research Center, Cancer Treatment Centers of America Chicago, Zion, IL.
Heather ColabellaDepartment of Pathology and Laboratory Medicine, Comprehensive Care and Research Center, Cancer Treatment Centers of America Chicago, Zion, IL.
Christopher SneadCHRISTUS Cancer Treatment Center, Shreveport, LA.
Marcia Cruz-CorreaPan American Center for Oncology Trials, Oncologic Hospital, Puerto Rico Medical Center, Rio Piedras, Puerto Rico.
Virginia RamirezPan American Center for Oncology Trials, Oncologic Hospital, Puerto Rico Medical Center, Rio Piedras, Puerto Rico.
Arnaldo RojasPan American Center for Oncology Trials, Oncologic Hospital, Puerto Rico Medical Center, Rio Piedras, Puerto Rico.
Huiya HuangDepartment of Pathology, Medical College of Wisconsin, Milwaukee.
Alexander C MackinnonDepartment of Pathology, Medical College of Wisconsin, Milwaukee.
Fernando U GarciaDepartment of Pathology and Laboratory Medicine, Comprehensive Care and Research Center, Cancer Treatment Centers of America Philadelphia, Philadelphia, PA.
Sharon M CavoneDepartment of Pathology and Laboratory Medicine, Comprehensive Care and Research Center, Cancer Treatment Centers of America Philadelphia, Philadelphia, PA.
Mutasim ElfahalDepartment of Pathology and Laboratory Medicine, Lahey Hospital and Medical Center, Beth Israel Lahey Health, Burlington, MA.
Gyorgy AbelDepartment of Pathology and Laboratory Medicine, Lahey Hospital and Medical Center, Beth Israel Lahey Health, Burlington, MA.
Mohammad A VasefDepartment of Pathology, University of New Mexico Health Sciences Center, Albuquerque.
Andrew JuddDepartment of Pathology, University of New Mexico Health Sciences Center, Albuquerque.
Mark W LinderDepartment of Pathology and Laboratory Medicine, University of Louisville Hospital, Louisville, KY.
Khaled AlkhateebDepartment of Pathology and Laboratory Medicine, University of Louisville Hospital, Louisville, KY.
William L SkinnerMercy Health-Paducah Medical Oncology and Hematology, Paducah, KY.
Ralph BocciaThe Center for Cancer and Blood Disorders, Bethesda, MD.
Kashyap PatelCarolina Blood and Cancer Care Associates, PA, Rock Hill, SC.

Funding

Translational Engineering in Cancer (TEC)P30CA023108 · NCI · DARTMOUTH COLLEGE · PI Steven D Leach · 1985 to 2026
$91.3M
NCI NIH HHS P30 CA023108
6 · The paper itself

Abstract

objectivesManagement 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.

methodsTwenty 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.

resultsThere 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.

conclusionsThe 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.

Indexed as

AdultAgedAged, 80 and overBiomarkers, TumorColorectal NeoplasmsDNA Mutational AnalysisFemaleGTP PhosphohydrolasesHigh-Throughput Nucleotide SequencingHumansMaleMembrane ProteinsMiddle AgedProto-Oncogene Proteins p21(ras)Standard of CareTime FactorsBiomarkers, TumorGTP PhosphohydrolasesKRAS protein, humanMembrane ProteinsNRAS protein, humanProto-Oncogene Proteins p21(ras)BRAFColorectal cancerKRASMolecular pathologyNRASPrecision medicine

Identifiers

PMID32525522
PMCPMC10893851

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.