Hitachi High-Tech and Invivoscribe partner to advance molecular diagnostics

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By undertaking a minority investment-based, third-party allotment of shares, Hitachi High-Tech has engaged in a strategic partnership (the Partnership) with Invivoscribe, a global provider of blood cancer testing kits and services. By combining Invivoscribe’s technology, assay and bioinformatics development, global clinical testing, and international regulatory expertise with Hitachi High-core Tech’s expertise in measurement and analysis systems technologies, the Partnership aims to accelerate both companies’ molecular diagnostics and precision medicine businesses.

1molecular diagnostics business: A business that analyses biomolecules like DNA, RNA, and protein in tissues and blood (body fluids) and gives information to healthcare practitioners for diagnosis and therapeutic agent selection.

Cancer therapies have just begun to offer personalized medicine, in which genes and proteins are analyzed in-depth and treatment is tailored to the specific patient. In the medical industry, there is an increasing demand for molecular diagnostics, which includes high-precision measurement instruments that detect genes and proteins, as well as testing services that provide doctors and patients with highly trustworthy results. These molecular diagnostic assays are being developed further as extremely precise, sensitive, and cost-effective procedures with minimum body burden. Molecular diagnostics are predicted to expand beyond drug selection for diagnostic and therapeutic purposes to early detection and prognosis monitoring.

Invivoscribe is a privately-held, California-based life science corporation with 7 wholly-owned subsidiaries in 5 countries, including clinical laboratories in 4 countries. Invivoscribe is engaged in three core business functions: 1) testing services for blood cancers, 2) global sales and distribution of test kits and licensing bioinformatics software, and 3) the development and commercialization of companion diagnostics to support pharmaceutical approval of new oncology treatments.

The Analytical & Medical Solutions Business of Hitachi High-Tech intends to promote growing enterprises in the life science and healthcare industries while also expanding its own in vitro diagnostics (IVD) business. This collaboration is part of Hitachi High Tech’s growth strategy to strengthen its molecular diagnostics business, whose mission is to contribute to the early detection and treatment of cancer, as well as the discovery of new drugs, by making molecular cancer diagnostics accessible to everyone, resulting in a healthy and secure society.

Through this strategic partnership, Hitachi High-Tech aims to cooperate across development, manufacturing, sales, and testing services, while developing systems that provide solutions that better address the on-site needs of cancer diagnosis and monitoring throughout the course of treatment.

“Invivoscribe is excited at the synergistic opportunities, combining our core expertise in global standardization of tests and bioinformatics, our clinical lab services, and our processes for developing custom companion diagnostics from analytical/clinical validations through international regulatory approvals and commercialization, with Hitachi’s expertise in instrumentation development and manufacturing. Hitachi manufactures and distributes in vitro diagnostic instruments that we currently use to standardize testing for the international community; we are looking forward to further deepening our Partnership so we can advance precision medicine worldwide,”

Jeffrey Miller, CEO and founder of Invivoscribe.

By incorporating digital and information technologies, Hitachi High-Tech will continue to strengthen and expand the IVD business, including the molecular diagnostic business, and contribute to improving the quality of medical care by providing solutions for early diagnosis and optimal cancer treatments to improve people’s QoL.

“Hitachi High-Tech has been strengthening its molecular diagnosis business centered on genetic testing. By combining Invivoscribe’s testing service business with our experiences gained from the equipment business, we aim to build a unique business model and provide a wide range of services to medical professionals,”

Yoshimitsu Takagi, Vice President and Executive Officer, and General Manager, Analytical & Medical Solution Business Group of Hitachi High-Tech.

Companion diagnostics are in-vitro diagnostics used to test a drug’s indication in order to improve its efficacy or safety.

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