Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu), a Japanese in vitro diagnostics company, and MolecularMD Corporation (HQ: Portland, Oregon, United States; President and CEO: Dan Snyder), a molecular diagnostics company, announced today a master collaboration agreement targeting the challenges in current and future companion diagnostics (CDx)* development and commercialization needed to accelerate precision medicine.
The non-exclusive collaboration agreement aims to build an effective and flexible cooperation structure that will enable the companies to combine their complementary capabilities and competencies in providing experienced best-in-class and tailored solutions to pharmaceutical customers across the world for CDx development and commercialization.
The CDx market space is evolving rapidly. As the healthcare system continues to see the benefits in reducing costs and improving patient outcomes, CDx tests will further contribute to everyday outcomes. This partnership addresses the challenges brought by this evolution to increase development speed, provide flexible structures for diagnostic test alignment with therapeutic drug approval and leverage US PMA, European CE, Japanese PMDA and APAC regulatory experience in accelerating CDx and therapeutic drug commercialization. This ultimately allows patients to have unparalleled global access to the CDx test and drug combination.
Going forward, there is a possibility for the expansion of this collaboration with additional parties that can share the objectives of the relationship and ensure best solutions to customers.
About Sysmex Corporation
Sysmex Corporation is a world leader in clinical laboratory systemization and solutions, including laboratory diagnostics, laboratory automation and clinical information systems. With a view to personalized medicine, the company has been exploring opportunities in liquid biopsy and companion diagnostics (CDx) with proprietary diagnostic technologies and experiences. Its technology portfolio and unique expertise in life science field includes Sysmex Inostics’ (www.sysmex-inostics.com) highly sensitive mutation detection technologies, such as BEAMing and Plasma Safe-Sequencing, RIKEN GENESIS’s (www.rikengenesis.jp/en) assay development, clinical validation and regulatory capabilities in Japan, Oxford Gene Technologies' (www.ogt.com) portfolio of assay kits and unique technologies from the UK. Headquartered in Kobe, Sysmex Corporation employs more than 8,000 employees worldwide. Sysmex Corporation is listed in the top tier of the Tokyo Stock Exchange. For more information about Sysmex Corporation and its affiliate companies, please visit www.sysmex.co.jp/en.
About MolecularMD
MolecularMD Corporation is a diagnostics company that enables the development and commercialization of precision medicines in oncology. Its tests are designed to allow appropriate selection, monitoring and management of patients treated with molecularly-targeted and immuno-oncology cancer therapies. MolecularMD integrates gold standard and innovative platform technologies with custom clinical assay design and validation to accelerate all phases of clinical development, including FDA approval and commercialization of in vitro companion diagnostic tests for novel anti-cancer agents. MolecularMD is the exclusive manufacturer of the MRDx® BCR-ABL Test. For more information, please visit www.molecularmd.com and www.mrdxtest.com.
Terminology
* Companion diagnostics: Clinical testing performed to predict the efficacy and side effects of drugs before using them for treatment, particularly testing that is performed at the same time as pharmaceutical development.
*Information contained in the press release is current as of the date of the announcement, but may be subject to change without prior notice.
