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Vol.61 No.7 contents

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- Original Article -

Exploratory Factors Relevant to the Success of the Oncomine™ Dx Target Test^®

Rie Sakakibara¹, Takayuki Honda¹, Takahiro Mitsumura¹, Susumu Kirimura², Kenichi Okubo³, Yasunari Miyazaki^1
1Department of Respiratory Medicine, ²Department of Surgical Pathology, ³Department of Thoracic Surgery, Tokyo Medical and Dental University, Japan

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Objective. The Oncomine™ Dx Target Test^® (ODxTT) has emerged as a companion diagnosing system for advanced non-small cell lung cancer (NSCLC) using next generation sequencing. However, the instability of the test results due to the small size of the biopsy samples makes it challenging to use in a clinical setting. Methods. From June 2018 to December 2020, NSCLC samples diagnosed in our hospital were evaluated. Fifty-one NSCLC samples were analyzed for BRAF mutations, and 19 biopsy samples were subjected to a multiplex analyses. The correlation between the clinicopathological factors and success rate was analyzed into integration. Results. The success rates according to procedure were 100% (25/25) for surgical samples, 100% for excisional biopsy samples, 75% for transbronchial biopsy samples, 78% for endobronchial ultrasound-transbronchial needle aspiration, and 57% for computed tomography-guided biopsy samples. The biopsy samples for which the analysis of BRAF mutations was successful showed a larger quantity of DNA than the failed group (median 279 vs. 18 ng, p<0.01). In a multiplex analysis, the quantity of DNA and RNA in the successful analysis samples showed a larger quantity than the failure samples (median quantity of DNA 198 vs. 45.6 ng, p<0.01; median quantity of RNA 180 vs. 34.2 ng, p<0.01). The number of biopsies in successful transbronchial biopsy cases and the tumor nuclei content in successful multiplex analyses cases were also greater than those in the failed samples (median number of biopsies 6.5 vs. 4, p<0.01, median tumor nuclei content 50% vs. 30%, p=0.01). Conclusion. The quantity of nucleic acid was associated with the analysis success rates of ODxTT. The tumor nuclei content and number of punctures for transbronchial biopsies might be associated with analysis success rates for ODxTT.
key words: Next generation sequencing, Oncomine^TM Dx Target Test^®, Biopsy samples, The quantity of nucleic acid, Tumor nuclei content

Received: January 3, 2021
Accepted: July 26, 2021

JJLC 61 (7): 932-938, 2021