Sysmex Inostics' OncoBEAM(TM) platform demonstrates superior detection of clinically-relevant mutations for therapy selection and molecular monitoring for lung and colon cancers

Hamburg, Germany (ots) - 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(TM) 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(TM) RAS test to Biocartis' Idylla platform for
detection of RAS mutations in plasma for patients with advanced-stage
colorectal cancer. The OncoBEAM(TM) 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(TM) 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(TM)
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(TM) 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(TM), 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(TM) 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(TM) 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(TM), 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."

Building on the proven high sensitivity of the OncoBEAM(TM) EGFR
test, the LungBEAM study conducted by researchers at 19 different
hospitals across Spain and led by Prof. Pilar Garrido sought to
evaluate the clinical value of longitudinal EGFR plasma testing in
tissue-confirmed advanced NSCLC patients during first-line EGFR TKI
therapy. The timing of emergence of the T790M resistance mutation was
examined, as well as the dynamics of EGFR sensitizing mutations
(L858R and exon 19 deletions) compared to radiological progression.
Out of 60 patients who completed the study and showed clinical or
radiological progression, 20 (33%) exhibited T790M present in plasma;
for 13 of these patients, T790M was detected an average of 14 weeks
prior to radiological progression. It was also found that clearance
of EGFR sensitizing mutations 8 weeks after initiation of EGFR TKI
therapy correlated with increased progression-free survival (40.3
weeks with clearance vs. 25.8 weeks without) and may be a favorable
clinical indicator of PFS that can be easily measured early during
therapy administration.

Together, these studies reinforce how the exquisite sensitivity of
the OncoBEAM(TM) platform which enables detection of the greatest
number of positive patients overall can deliver unique clinical
value. A highly sensitive assay is especially important for timely
detection of mutations that can be monitored in real time as
surrogate biomarkers of disease burden. "The demonstrated high
sensitivity of OncoBEAM(TM) is ideal not only to maximize detection
of known therapeutic indications, but also to explore potential
clinical uses of ctDNA to monitor disease evolution at much higher
resolution that is currently possible through radiographic imaging,"
commented Dr. Pilar Garrido, lead investigator for the LungBEAM
study. "At a time when many different technologies and products are
available for molecular oncology, it has become increasingly
important for researchers and clinicians to select the best option to
answer the specific question at hand."

Presentation Details (all times local)

- Saturday, October 20th,12:30, Biomarkers, 100P: Comparison of
OncoBEAM and NGS methods to detect plasma EGFR T790M mutations at
progression of NSCLC.

- Saturday, October 20th, 12:30, Biomarkers, 121P: LungBEAM: A
prospective multicenter trial to monitor EGFR mutations using
BEAMing technology in Stage IV NSCLC patients.

- Sunday, October 21st, 13:05, Gastrointestinal tumors - colorectal,
550P: Evaluation of the sensitivity of RAS mutation detection of
the Idylla platform in comparison to the OncoBEAM RAS CRC assay.

About OncoBEAM(TM)

Sysmex Inostics' highly sensitive OncoBEAM(TM) services allow for
molecular genetic analysis of cell-free tumor DNA from blood or
plasma, delivering an individualized approach to complement treatment
decision-making in oncology. Based on the highly sensitive BEAMing
technology developed at the Johns Hopkins University School of
Medicine, OncoBEAM(TM) testing is able to provide multiplex hotspot
mutation analysis for the accurate and reliable detection of rare
mutant molecules of tumor DNA from blood samples of patients with
cancer. Due to its minimal-invasive nature, OncoBEAM(TM) delivers new
possibilities for cancer management while minimizing costs and risks
inherent with tissue biopsies. The OncoBEAM(TM) assays target a wide
variety of clinically actionable genetic mutations in various cancers
like melanoma, colorectal, breast and lung cancer, delivering
information in real-time to support therapy selection, detection of
emergent mutations and assessment of drug response. In the US,
OncoBEAM(TM) tests are available as GCP and CLIA services.
OncoBEAM(TM) RAS CRC CE IVD kit is available in EU.

About Sysmex Inostics

Sysmex Inostics, a subsidiary of Sysmex Corporation, is a
molecular diagnostic company whose core competency is mutation
detection utilizing highly sensitive technologies such as BEAMing and
Plasma Safe-Sequencing. Sysmex Inostics is a trusted partner to
leading pharmaceutical companies, advancing their efforts to bring
the most effective personalized cancer therapies to global markets.

With BEAMing and Plasma Safe-Sequencing (SafeSeq) being some of
the most sensitive technologies available today for the detection of
tumor-specific somatic mutations in blood samples, Sysmex Inostics'
services are readily available to support clinical trials and
research in oncology. In addition, OncoBEAM(TM) tests are available
today through a CLIA-certified laboratory for routine clinical
analysis.

Sysmex Inostics' headquarters and GCP Service Laboratory are
located in Hamburg Germany; Sysmex Inostics' Commercial Offices and
CLIA-certified and GCP Clinical Laboratory is located in Baltimore,
Maryland. For more information on Plasma Safe-Sequencing and
OncoBEAM(TM) blood testing, please visit 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

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