Virtual Library
Start Your Search
Fumiyoshi Ohyanagi
Author of
-
+
P37 - Pathology - Biomarker Testing (ID 107)
- Event: WCLC 2020
- Type: Posters
- Track: Pathology, Molecular Pathology and Diagnostic Biomarkers
- Presentations: 1
- Moderators:
- Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
-
+
P37.08 - OncomineTM Dx Target Test Companion Diagnostic System for Advanced Non-Small Cell Lung Cancer (ID 1131)
00:00 - 00:00 | Presenting Author(s): Fumiyoshi Ohyanagi
- Abstract
Introduction
Recent advances in genotyping technologies have led to a paradigm shift in cancer companion diagnostics (CDx), which now include both single gene–based tests and multiplexed next–generation sequencing (NGS)–based assays. The Oncomine Dx Target Test CDx system (Oncomine DxTT) is an NGS panel for evaluating non-small cell lung cancer (NSCLC) that was approved for clinical use in June 2019 in Japan. While the approximate amount of tumor content and tissue size were required for successful and reliable sequencing, sampling in lung cancer has limitations and risks. Very little evidence has been reported on the rates at which mutation status was successfully determined across multiple biomarkers in small samples.
Methods
We conducted a molecular assessment of formalin-fixed paraffin-embedded lung tissue samples and performed investigational testing using the Oncomine DxTT kit. The primary objective of this study was to assess test success rates, turnaround time (TAT) with respect to the ratio of tumor to unaffected tissues in the target samples. We evaluated these variables by sample type using real world data.
Results
From September to December in 2019, tissue samples from 49 patients were evaluated retrospectively. Most of the samples available for molecular testing were small in size, and included transbronchial lung biopsies (TBLB; 46.9%), core needle biopsies (CNB; 14.3%) endobronchial ultrasonography-guided biopsy using a guide sheath (EBUS–GS; 4.1%), and endobronchial ultrasound-guided transbronchial needle aspiration (EBUS–TBNA; 6.3%). We collected resected surgical samples from 18 of the 49 patients (36.7%). The success rates for each sample type were 94.7% and 100% for analysis of DNA and RNA, respectively for TBLB, 100% and 100% for CNB, 80% and 100% for EBUS–GS and EBUS–TBNA, and 100% and 83.3% with resected tissue samples. Median TAT for all samples was 13 days (range 7–19). Median TAT of specific samples types included 12 days (range 9–17) for TBLB, 14 days (range 10–19) for CNB, 14 days (range 11–18) for EBUS–GS and EBUS–TBNA, and 15 days (range 7–19) for the resected tissue samples. The percentage of samples containing >30% tumor issue included 42.1% for TBLB, 71.4% for CNB, 40% for EBUS–GS and EBUS–TBNA, and 50% for the surgically resected samples.
Conclusion
The results from CDx provide critical support for clinical decision-making for patients with advanced NSCLC. Our assessment suggests that use of the Oncomine DxTT could facilitate testing for multiple biomarkers in small tissue samples.
