The development of assay reagents using next-generation sequencers (NGS) has seen significant advancements in recent years. However, challenges such as long measurement times and high running costs have underscored the need for novel solutions to be widely adopted in clinical settings.

In response to these challenges, both companies embarked on a FS agreement in August 2023 to explore the development of new genetic testing systems. By leveraging Hitachi High-Tech's CE sequencer technology and Sysmex's expertise in NGS reagent development and analysis technology, the collaboration aims to pioneer efficient genetic testing systems at a reduced cost.

Having achieved critical milestones in the FS agreement, Sysmex and Hitachi High-Tech will now focus on developing genetic testing systems tailored for widespread clinical adoption. Hitachi High-Tech will work on obtaining medical device approval for CE sequencers, while Sysmex will concentrate on developing and securing regulatory approval for testing reagents and analysis software. Initial efforts will be directed towards clinical applications in oncology before expanding into other disease areas.

Through the amalgamation of their respective technologies and expertise, Sysmex and Hitachi High-Tech aim to introduce new genetic testing systems offering shorter measurement times and lower running costs, thereby facilitating enhanced patient care and treatment outcomes.