Sysmex Inostics OncoBEAM(TM)-EGFR digital PCR liquid biopsy demonstrates two-fold higher detection of p.T790M mutations in 183 NSCLC patients in comparison study

Hamburg/Baltimore (ots) - Sysmex Inostics announces the
publication of clinical research conducted as part of the CIRculating
CANcer (CIRCAN) Program at the Lyon Cancer Institute (Lyon, France)
comparing the performance of Sysmex Inostics BEAMing (beads,
emulsion, amplification, and magnetics) assay for EGFR resistance
mutations (OncoBEAM-EGFR) to a next-generation sequencing assay (56G
Oncology Panel from Swift Biosciences) in non-small cell lung cancer
(NSCLC) patients with EGFR sensitizing mutations under first-line
tyrosine kinase inhibitor (TKI) therapy.

The OncoBEAM-EGFR assay detected the p.T790M EGFR resistance
mutation in twice as many patients (40/183 or 21.8% versus 20/183 or
10.9%), and those that were positive only on the OncoBEAM assay had a
mean allele fraction of only 0.13%. This report also used the
OncoBEAM-EGFR assay in a circulating tumor cell (CTC) spiking
experiment, where the p.T790M mutation was detected in as few as 1.33
cells per mL of blood.

This research demonstrating sensitivity of 0.1% allele frequency
in as little as 2 nanograms (2 ng) of input material was recently
published in Cancer Medicine (Garcia and Couraud et al,
https://onlinelibrary.wiley.com/doi/full/10.1002/cam4.2244) and was
previously presented at the 2018 ESMO congress
(http://ots.de/P8G5O3).

Principal investigator, Prof. Léa Payen from the Hospices Civils
de Lyon commented on the results, "Given the high level of
variability of tumor content in NSCLC patient plasma specimens and
the great therapeutic utility of identifying an actionable EGFR
mutation like T790M in a liquid biopsy specimen, it is of paramount
importance to ensure mutation detectability at low allelic frequency.
In our experience, plasma testing with OncoBEAM EGFR enabled us to
detect the EGFR p.T790M mutation across a greater number of patients
than NGS, representing a substantial proportion of patients that
stand to benefit from targeted therapy."

Sysmex Inostics will highlight six posters and abstracts using
OncoBEAM digital PCR and the new SafeSEQ NGS liquid biopsy technology
at the upcoming American Society for Clinical Oncology conference and
exhibition (booth 2098) in Chicago IL from May 31 to June 3, 2019.

About Sysmex Inostics

Sysmex Inostics, a subsidiary of Sysmex Corporation, is a
molecular diagnostic company that is a pioneer in blood-based
cell-free tumor DNA (ctDNA) mutation detection in oncology utilizing
highly sensitive technologies such as OncoBEAM(TM) (digital PCR) and
SafeSEQ (NGS). These technologies were initially developed by experts
at the Johns Hopkins School of Medicine over a decade ago and this
deep expertise in ctDNA analysis extends to the core of Sysmex
Inostics' capabilities for technology development and implementation.

With more than 10 years' of experience in liquid biopsy Sysmex
Inostics is a trusted partner to leading pharmaceutical companies,
advancing their efforts to bring the most effective personalized
cancer therapies to global markets, from discovery through companion
diagnostics.

Sysmex Inostics' OncoBEAM(TM) and SafeSEQ services are readily
available to support clinical trials and research in oncology. In
addition, OncoBEAM(TM) tests are available through a CLIA certified
laboratory for routine clinical analysis as well as distributed kit
products in the EU.

Sysmex Inostics' headquarters and GCP Service Laboratory are
located in Hamburg Germany; Sysmex Inostics' CLIA-certified and GCP
Clinical Laboratory is located in Baltimore, Maryland. For more
information refer to www.sysmex-inostics.com or email
info@sysmex-inostics.com.

Contact:
Sysmex Inostics
Press Release
Phone: +49-(0)-40-3259070
Mail: info@sysmex-Inostics.com

Original-Content von: Sysmex Inostics GmbH, übermittelt durch news aktuell