Download Companion Diagnostic Services

Companion Diagnostic
Services
www.sysmex-inostics.com
A Single-Source Partner to Pharmaceutical
Companies for a Full Spectrum of
Companion Diagnostic Services
Sysmex Inostics develops and commercializes innovative, blood-based
diagnostic tests. We are a trusted partner to leading pharmaceutical
companies, advancing their efforts to bring the most effective
personalized cancer therapies to global markets.
Collaborative Approach
Sysmex Inostics is a strategic partner to pharmaceutical companies.
Our scientific expertise—combined with legal, regulatory, product
launch, marketing, and physician education capabilities—creates the
foundation for successful commercialization of companion diagnostic
products. In this way, Sysmex Inostics together with our pharmaceutical
partners have measurable impact on the delivery of personalized
medicine to growing numbers of patients around the world.
Our Proven Ability to Deliver
Meeting the many challenges inherent in cancer drug development
is the constant focus of Sysmex Inostics. Our pharmaceutical
clients can depend on:
Broad-based services
-Feasibility studies
-Clinical validation
-Custom companion diagnostic development
-Commercialization of kits to global markets
PHAMACEUTICAL
PARTNERS
n
n
SALES
& MARKETING
CHANNELS
ASSAY
DEVELOPMENT
GCP / CLIA compliance
Sysmex
Inostics
n
A
team of experts providing essential support that ensures
timely delivery of project milestones
n
Gold-standard OncoBEAM™ technology, a blood-based mutation
assay that requires no tissue
-Non-invasive specimen collection, supporting high enrollment
and patient compliance
-Sensitive detection of rare cancer gene mutations
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Support patient stratification for more efficient clinical
studies and trials
-Highly sensitive, real-time assessment of tumor status
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Global regulatory expertise in key regions, including but not
limited to US FDA, Japan MHLW, and China FDA
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Strict quality control systems
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Part of the Sysmex family, a top 10 IVD company with commercial
activities in 175+ countries
cGMP
MANUFACTURING
REIMBURSEMENT
REGULATORY
APPROVALS
Sysmex Inostics Provides
n Biomarker assay development
n Analytical validation
n Clinical validation
n Kit development
n Regulatory registration/
approval (510k, PMA, CFDA, CE)
CLINICAL
TRIALS
n
cGMP manufacturing
GCP/CLIA certified testing
services
n Project management
n Commercialization
n
Sysmex Inostics is a molecular diagnostics company that provides testing for research and cancer drug development companies, as well as
clinical testing for physicians. The company offers highly sensitive assays that detect mutations from plasma and serum samples. We serve
clients around the world from our offices and laboratories in the United States, Germany, China, and Japan.
To learn how Sysmex Inostics can advance cancer drug development in your organization, please call 1-855-BEAM-DNA (232-6362).
Sysmex Inostics GmbH
Falkenried 88, 20251 Hamburg, Germany · Phone +49 40 413383-90 · Fax +49 40 413383-99 · [email protected] · www.sysmex-inostics.com
Sysmex Inostics, Inc.
One Nelson C. White Parkway, Mundelein, Illinois 60060, USA · Phone Toll-Free: +1-855-BEAM-DNA (232-6362) · [email protected] · www.sysmex-inostics.com
Sysmex Corporation
1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073, Japan · Phone +81 78 265-0500 · Fax +81 78 265-0524 · www.sysmex.co.jp
CDX.EN.N.8/14
© Copyright 2014 – Sysmex Inostics GmbH