The alliance follows a marketing deal signed with Sysmex Europe that covers Europe, the Middle East, and Africa.
The XW-100 Automated Hematology Analyzer previously received 510(k) clearance. With the CLIA waiver, the test can be run in more types of healthcare facilities.
The firm said that entry into the market is a logical progression based on its existing position and strength in hematology, an adjacent segment.
The collaboration among the National Cancer Center Japan, JVCKENWOOD, Sysmex, and Daiichi Sankyo aims to detect cancer-specific exosomes from patients' blood.
The two companies plan to secure required initial regulatory approvals in individual African territories before expanding to other areas in the region.
The subsidiary of Sysmex is evaluating two liquid biopsy technologies for their abilities to monitor patient response to chemotherapy in breast cancer patients.
The companies formed the joint venture in 2008 to commercialize BioMérieux's IVD products and medical instruments in Japan.
The acquisition allows Sysmex to enter the cytogenetics market and strengthens its technology base in molecular genetics, while expanding its life science business.