Abstract 3614
Background
The clinical utility of non-invasive liquid biopsy and ability to accurately detect EGFR mutations in circulating-tumor DNA of patients with NSCLC has been well demonstrated. This expands the pool of patients eligible for molecular testing. The cobas® EGFR Mutation Test v2 (cobas test) is a real-time PCR test for qualitative and semi-quantitative detection of 42 EGFR mutations in DNA from tissue and circulating free DNA (cfDNA) from K2 EDTA plasma. Blood collected in K2 EDTA requires plasma be separated within 8 hours, which can be a barrier to molecular testing and thus impact treatment decisions. The Roche Cell-Free DNA Collection Tube (Roche cfDNA) stabilizes blood up to 8 days, allowing greater flexibility in transportation and time to plasma separation. Here the suitability of plasma from Roche cfDNA tubes for use with the cobas test is demonstrated.
Methods
Test performance with Roche cfDNA plasma was verified with NSCLC patient specimens or surrogate samples (sheared cell line DNA in healthy donor plasma). Correlation was tested using paired draws in K2 EDTA and Roche cfDNA tubes for 51 NSCLC patients and 20 healthy donor surrogate samples. Limit of detection (LoD) and linearity established with K2 EDTA plasma were verified with Roche cfDNA plasma. Reproducibility was assessed using surrogate samples at two levels with multiple operators, Roche cfDNA tube lots, instruments, days and sites. Blood storage conditions were established at an external laboratory with 6 NSCLC patient specimens.
Results
Compared to K2 EDTA plasma, Roche cfDNA plasma had a PPA, NPA and OPA of 100.0% with the cobas test. LoD for EGFR mutation detection in Roche cfDNA plasma was verified as ≤ 100 cp/mL. Linearity for EGFR mutations in Roche cfDNA plasma was verified. The reproducibility study had a call agreement of ≥ 98.6%. Blood in Roche cfDNA tubes was stable for up to 8 days at 18-25ºC with one excursion of up to 24 hours at 15-30ºC prior to separation.
Conclusions
Use of the Roche cfDNA tube with the cobas® EGFR Mutation Test v2 provides the flexibility to store blood for up to 8 days prior to separation, with equivalent performance to K2 EDTA plasma, and facilitates use of liquid biopsy for NSCLC patients needing molecular testing.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Roche Molecular Systems Inc.
Funding
AstraZeneca PLC.
Disclosure
T.E. May: Full / Part-time employment: Roche Molecular Solutions. S.A. Scudder: Shareholder / Stockholder / Stock options, Full / Part-time employment: Roche Molecular Solutions. S.J. Joshi: Full / Part-time employment: Roche Molecular Solutions. M. Kohlmann: Shareholder / Stockholder / Stock options, Full / Part-time employment: AstraZeneca, PLC. N. Shrestha: Full / Part-time employment: Roche Molecular Solutions. N. Lee: Full / Part-time employment: Roche Molecular Solutions. J. Lai: Full / Part-time employment: Roche Molecular Systems Inc. M. Tsourounis: Shareholder / Stockholder / Stock options, Full / Part-time employment: AstraZeneca PLC. A. Kohlmann: Shareholder / Stockholder / Stock options, Full / Part-time employment: AstraZeneca PLC. P. O’Donnell: Full / Part-time employment, Spouse / Financial dependant: Roche Molecular Systems. H. Halait: Shareholder / Stockholder / Stock options, Full / Part-time employment: Roche Molecular Systems. All other authors have declared no conflicts of interest.
Resources from the same session
2607 - Single cycle induction treatment with Cisplatin/Docetaxel plus Durvalumab/Tremelimumab in Stage III-IVB head and neck squamous cell cancer (CheckRad-CD8 trial)
Presenter: Markus Hecht
Session: Poster Display session 3
Resources:
Abstract
1388 - Radiotherapy plus cisplatin (CDDP) or cetuximab (C225) in human papilloma-virus (HPV)-associated oropharyngeal cancer (OPC)? A dillema finally resolved. An updated meta-analysis.
Presenter: Petar Suton
Session: Poster Display session 3
Resources:
Abstract
1478 - Treatment outcomes of head and neck cancer patients 70 years and older receiving different chemo-radiation combinations.
Presenter: Majd Issa
Session: Poster Display session 3
Resources:
Abstract
3985 - Brachytherapy and non-cancer mortality in patients with oral cavity and oropharynx SCCs
Presenter: Jovian Yu
Session: Poster Display session 3
Resources:
Abstract
4036 - Final results of a phase II study of induction chemotherapy (CT) with paclitaxel (PTX) and panitumumab (P) followed by radiotherapy (RT) and P in patients (pts) with locally advanced head and neck cancer (LAHNC) no candidates to platinum: study PANTERA
Presenter: Javier Martinez Trufero
Session: Poster Display session 3
Resources:
Abstract
4779 - Window of Opportunity for Durvalumab (MEDI4736) plus Metformin Trial in Squamous Cell Carcinoma of the Head and Neck (SCCHN): interim safety analysis
Presenter: Tony Richa
Session: Poster Display session 3
Resources:
Abstract
2757 - Severe Oral Mucositis (SOM) Mitigation by Genetically Modified Lactococcus Lactis Bacteria (LLB) Producing Human Trefoil Factor 1 (hTFF1; AG013) in Patients Being Treated With Concomitant Chemoradiation (CRT) for Oral and Oropharyngeal Cancers (OCOPC)
Presenter: Suraj Singh
Session: Poster Display session 3
Resources:
Abstract
5559 - Transcriptome signatures of treatment responses in a preoperative window of opportunity trial of nivolumab and tadalafil in resectable squamous cell carcinoma of the head and neck
Presenter: Sanket Shukla
Session: Poster Display session 3
Resources:
Abstract
3263 - Risk and Impact of Renal Impairment of Locally Advanced Head and Neck Squamous Cell Carcinoma Patients Who Received Chemoradiotherapy with Cisplatin
Presenter: Thana Patimarattananan
Session: Poster Display session 3
Resources:
Abstract
3128 - Systemic bevacizumab for the treatment of recurrent respiratory papillomatosis: A retrospective analysis from an academic tertiary care center
Presenter: Sumita Trivedi
Session: Poster Display session 3
Resources:
Abstract