Sysmex Inostics launches two NGS-based liquid biopsy panels for cancer therapy drug development

Hamburg, Germany and Baltimore, Maryland (ots) - Sysmex Inostics
announces the availability of the SafeSEQ Breast Cancer and Head and
Neck Cancer Panels along with the SafeSEQ Rapid Custom Development
program for circulating tumor DNA (ctDNA) analysis. SafeSEQ is a
next-generation sequencing (NGS)-based approach that delivers
sensitivity comparable to the clinically validated OncoBEAM platform
for rare mutant molecule detection, with sensitivity down to five
mutant molecules amongst ten thousand wildtype copies, or 0.05%
mutant allele frequency (MAF).

The SafeSEQ Breast Cancer Panel tests for mutations affecting the
PIK3CA, ESR1, TP53, ERBB2, AKT1 and KRAS genes in ER-positive,
HER2-negative breast cancer samples. Alterations in these genes can
guide an oncologist's selection of appropriate therapy, clinical
trial enrollment, or indicate mechanisms of therapy resistance. The
SafeSEQ Breast cancer panel provides unparalleled highly sensitive
detection of mutant ctDNA and is thus also well suited for disease
monitoring in order to assess treatment response, minimal residual
disease and molecular relapse.

The SafeSEQ Head and Neck Cancer Panel tests for mutations in the
genes PIK3CA, CDKN2A, HRAS and TP53. Although head and neck squamous
cell carcinoma (HNSCC) affects approximately 600,000 globally,
molecular testing is not routinely performed, and a number of
molecular alterations in these genes are actively being pursued as
therapeutic targets. A primary challenge in HNSCC is that many
patients exhibit low levels of ctDNA with the vast majority having a
MAF below 1%. Below this level, many liquid biopsy tests have
demonstrated poor performance. Sysmex Inostics has demonstrated
reliable, high-sensitivity detection well below this level with
detection of as few as five mutant molecules in a background of ten
thousand wildtype ones, or a MAF of 0.05%.

"In the fast-growing field of liquid biopsy for cancer therapy
selection and monitoring of recurrent disease, assay sensitivity is
paramount" says Dr. Frank Holtrup, Director of R&D at Sysmex
Inostics. "We have worked hard to optimize every step of the assay
process, from sample collection through processing and bioinformatics
to ensure industry-leading sensitivity down to single mutant
molecules for our SafeSEQ liquid biopsy tests."

In addition to the standard SafeSEQ panels, Sysmex Inostics offers
a Rapid Custom Development program, where client-selected target
genes and mutations can be assembled into highly sensitive
fit-for-purpose assays with customer-selected levels of analytical
and clinical validation.

At the European Society of Molecular Oncology in Barcelona, Spain
September 27 - October 2, 2019 Sysmex Inostics will be exhibiting at
Booth 250 in Hall 2, and several posters will demonstrate the utility
of Sysmex Inostics enhanced digital PCR OncoBEAM and NGS-based
SafeSEQ technology for liquid biopsy, including the following:

"Clinical relevance of circulating tumor (ct)DNA genotyping for
first line cetuximab-based treatment monitoring in metastatic
colorectal cancer (mCRC): a prospective multicentric study" (Dr.
Joana Vidal Barrull, poster 625P, 29 Sept 2019 1200). "Sequential RAS
mutation testing in cfDNA in RAS wild type (wt) metastatic colorectal
cancer (mCRC) patients (pt) treated with panitumumab (P) and
chemotherapy (CT) in first line (1L) PERSEIDA study" (Dr. Manuel
Valladares-Ayerbes, poster 531PD, 29 Sept 2019 1200).

"Blood-based testing of mutations in patients with Head and neck
squamous cell carcinoma (HNSCC) using highly sensitive SafeSEQ
technology" (Dr. Florentia Fostira, poster 1158P, 30 Sept 2019 1200).

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 and Asia Pacific.

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

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