Evaluation of appropriate conditions for Oncomine DxTT testing of FFPE specimens for driver gene alterations in non–small cell lung cancer

The Oncomine Dx Target Test Multi‐CDx System (ODxTT) is a next‐generation sequencing panel approved as a companion diagnostic for drugs targeted to corresponding gene alterations in non–small cell lung cancer. However, appropriate slide conditions for ODxTT have remained unclear.

[1]  K. Okudela,et al.  Pathological criteria for multiplex gene-panel testing using next-generation sequencing in non-small cell lung cancer. , 2022, Cancer treatment and research communications.

[2]  Kentaro Fujiwara,et al.  Comparison of the analytical performance of the Oncomine dx target test focusing on bronchoscopic biopsy forceps size in non‐small cell lung cancer , 2022, Thoracic cancer.

[3]  H. Yoshida,et al.  Real‐world data on NGS using the Oncomine DxTT for detecting genetic alterations in non‐small‐cell lung cancer: WJOG13019L , 2021, Cancer science.

[4]  A. Ochiai,et al.  The Japanese Society of Pathology Practical Guidelines on the handling of pathological tissue samples for cancer genomic medicine , 2021, Pathology international.

[5]  M. Nishio,et al.  Feasibility of next‐generation sequencing test for patients with advanced NSCLC in clinical practice , 2020, Thoracic cancer.

[6]  M. Masuda,et al.  Tissue surface area and tumor cell count affect the success rate of the Oncomine Dx Target Test in the analysis of biopsy tissue samples , 2020, Thoracic cancer.

[7]  J. Desai,et al.  KRASG12C Inhibition with Sotorasib in Advanced Solid Tumors. , 2020, The New England journal of medicine.

[8]  H. Groen,et al.  Capmatinib in MET Exon 14-Mutated or MET-Amplified Non-Small-Cell Lung Cancer. , 2020, The New England journal of medicine.

[9]  A. Drilon,et al.  Efficacy of Selpercatinib in RET Fusion-Positive Non-Small-Cell Lung Cancer. , 2020, The New England journal of medicine.

[10]  Jie Yang,et al.  Tepotinib in Non‐Small Cell Lung Cancer with MET Exon 14‐Skipping Mutations or MET Amplification: a Phase 2 Trial in Progress: OA06 , 2018, The New England journal of medicine.

[11]  J. Subramanian,et al.  Performance of next-generation sequencing on small tumor specimens and/or low tumor content samples using a commercially available platform , 2018, PloS one.

[12]  Ying Cheng,et al.  Osimertinib in Untreated EGFR-Mutated Advanced Non–Small-Cell Lung Cancer , 2018 .

[13]  Young Hak Kim,et al.  Alectinib versus crizotinib in patients with ALK-positive non-small-cell lung cancer (J-ALEX): an open-label, randomised phase 3 trial , 2017, The Lancet.

[14]  Rafal Dziadziuszko,et al.  Alectinib versus Crizotinib in Untreated ALK‐Positive Non–Small‐Cell Lung Cancer , 2017, The New England journal of medicine.

[15]  J. Yokota,et al.  Gene aberrations for precision medicine against lung adenocarcinoma , 2016, Cancer science.

[16]  Ariel Birnbaum,et al.  Clinical Trial Accrual Targeting Genomic Alterations After Next-Generation Sequencing at a Non-National Cancer Institute-Designated Cancer Program. , 2016, Journal of oncology practice.

[17]  R. Goswami,et al.  Analysis of Pre-Analytic Factors Affecting the Success of Clinical Next-Generation Sequencing of Solid Organ Malignancies , 2015, Cancers.

[18]  Rakesh Nagarajan,et al.  Clinical next‐generation sequencing in patients with non–small cell lung cancer , 2015, Cancer.

[19]  K. Arnaoutakis Crizotinib in ROS1-rearranged non-small-cell lung cancer. , 2015, The New England journal of medicine.

[20]  Jeffrey W. Clark,et al.  Crizotinib in ROS1-rearranged non-small-cell lung cancer. , 2014, The New England journal of medicine.

[21]  Stefan M Willems,et al.  The estimation of tumor cell percentage for molecular testing by pathologists is not accurate , 2014, Modern Pathology.

[22]  David L Rimm,et al.  A prospective, multi-institutional diagnostic trial to determine pathologist accuracy in estimation of percentage of malignant cells. , 2013, Archives of pathology & laboratory medicine.

[23]  Michael Thomas,et al.  Crizotinib versus chemotherapy in advanced ALK-positive lung cancer. , 2013, The New England journal of medicine.

[24]  Yi-long Wu,et al.  Mutation incidence and coincidence in non small-cell lung cancer: meta-analyses by ethnicity and histology (mutMap) , 2013, Annals of oncology : official journal of the European Society for Medical Oncology.

[25]  T. Mok,et al.  Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. , 2009, The New England journal of medicine.

[26]  C. Morrison,et al.  Multiple Biomarker Testing Tissue Consumption and Completion Rates With Single‐gene Tests and Investigational Use of Oncomine Dx Target Test for Advanced Non–Small‐cell Lung Cancer: A Single‐center Analysis , 2019, Clinical lung cancer.

[27]  T. Miyazaki,et al.  Brief Report: Calculating the Tumor Nuclei Content for Comprehensive Cancer Panel Testing. , 2019, Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer.

[28]  H. Groen,et al.  Dabrafenib plus trametinib in patients with previously treated BRAF(V600E)-mutant metastatic non-small cell lung cancer: an open-label, multicentre phase 2 trial. , 2016, The Lancet. Oncology.