Sysmex obtains Japanese manufacturing and marketing approval for the first blood-based RAS mutation testing for colorectal cancer

Kobe, Japan (ots) - Sysmex Corporation has obtained Japanese
manufacturing and marketing approval for the OncoBEAM(TM) RAS CRC
Kit, used for blood-based circulating tumor DNA (ctDNA) molecular
testing of mutations in the RAS gene for advanced colorectal cancer
patients. With clinically-validated high sensitivity and specificity
for ctDNA molecular characterization and an extensive publication
history, the approval of the OncoBEAM RAS CRC Kit marks the first
approval of a liquid biopsy test in Japan and will provide CRC
patients with a viable alternative to tissue testing. Availability of
the OncoBEAM RAS CRC kit in Japan will reduce the need for invasive
tissue biopsy and expedite the delivery of important molecular
information required for the accurate prescription of therapy for
patients suffering from colorectal cancer.

Jointly developed between Sysmex Corporation subsidiary Sysmex
Inostics and Merck KGaA Darmstadt, Germany, the OncoBEAM RAS CRC Kit
received CE Marking in 2016 (CE = European Conformity, certification
mark in European Economic Area). For the approval in Japan, eight
facilities were involved in a multi-center evaluation, including the
National Cancer Center Hospital East (Kashiwa City, Japan). Across
the world, numerous peer-reviewed publications have demonstrated the
robust clinical performance of the OncoBEAM RAS CRC Kit, and its
availability in Japan is anticipated to greatly improve the
management of patients with colorectal cancer.

By providing timely information from ctDNA in the bloodstream of
colorectal cancer patients, OncoBEAM RAS testing can be used by
physicians to determine whether to use molecularly targeted anti-EGFR
drugs (e.g. Cetuximab) in the course of treatment. Sysmex Corporation
anticipates launching an OncoBEAM RAS CRC Assay Service to further
widen adoption of this important capability for precision medicine
for Japanese patients, in addition to applying for national insurance
coverage.

The manufacturing and marketing approval in Japan was obtained 19
July 2019 from Japan's Ministry of Health, Labour and Welfare (MHLH),
approval number 30100EZX00010000.

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

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