Sysmex Inostics' OncoBEAM Platform Demonstrates Superior Detection of Clinically-relevant Mutations for Therapy Selection and Molecular Monitoring for Lung and Colon Cancers

HAMBURG, Germany, October 18, 2018 /PRNewswire/ --

Data presented at the European Society of Medical Oncology (ESMO) 2018 meeting in Munich, Germany by three clinical oncology research groups demonstrate the importance of a highly sensitive test for detection of clinically-relevant mutations present in circulating tumor DNA (ctDNA) derived from a simple blood draw. Sysmex Inostics' ultra-high sensitivity OncoBEAM test was able to uncover mutations below the limits of detection for next-generation sequencing (NGS) as well as quantitative PCR (qPCR) tests, which represents a subset of patients for whom these lower-sensitivity methods could potentially miss important clinically actionable information.

In a study sponsored by the Cancer Genomics Group at Vall d'Hebron Institute of Oncology in Barcelona, investigators compared Sysmex Inostics' OncoBEAM RAS test to Biocartis' Idylla platform for detection of RAS mutations in plasma for patients with advanced-stage colorectal cancer. The OncoBEAM test uses BEAMing technology, an enhanced digital PCR method optimized for high sensitivity across different specimen types, while Idylla employs qPCR and is designed primarily for ease-of-use for mutational analysis of tissue and plasma specimens. Comparison of Idylla with reference results generated by the OncoBEAM assay, the current gold-standard for highly sensitive liquid biopsy, demonstrated inferior performance of Idylla with detection of KRAS mutations in only 81 out of 116 (70%) positive plasma samples. As expected, concordance with OncoBEAM substantially decreased at lower mutant allele frequency (MAF), which is representative of lower sensitivity achieved by qPCR techniques such as Idylla.

In another study, investigators at Hospices Civiles de Lyon evaluated Sysmex Inostics' OncoBEAM EGFR test as well as the 56G oncology NGS panel from Swift Biosciences for detection of the EGFR T790M resistance mutation present in advanced NSCLC patients on first-line EGFR tyrosine kinase inhibitor (TKI) therapy for whom progression was suspected.  OncoBEAM, which has pioneered acceptance of liquid testing for lung cancer in routine clinical practice, was able to detect T790M in a greater number of patients than the 56G oncology NGS panel. Notably, all positives detected by OncoBEAM but not 56G oncology NGS exhibited T790M present below 0.35% MAF, which is below the limit of detection for the NGS panel in this study (0.5% MAF) but in the range of reliable detection for the OncoBEAM test (LOD 0.02% MAF). As Dr. Lea Payen commented, "Resistance mutations such as T790M represent a significant therapeutic opportunity for NSCLC patients experiencing disease progression. However, detection T790M is often confounded due to its heterogeneous distribution throughout a patient's tumor burden which presents a diagnostic challenge for single-site tissue biopsies. Further, EGFR sensitizing and T790M mutations have been shown to be present at low allelic frequencies due to variable and sometimes limited ctDNA amounts in the plasma for NSCLC patients. The implementation of a highly sensitive assay like OncoBEAM, which demonstrates reliable performance at low mutant allelic frequencies, is important in the context of NSCLC in order to reliably detect ctDNA in blood samples that may be missed by less sensitive approaches."