Sysmex and MolecularMD have signed a non-exclusive collaboration agreement focused on the development and commercialization of companion diagnostics for precision medicine.
As part of the collaboration, the firms said they will integrate their capabilities and competencies to offer solutions to global pharmaceutical customers for CDx development and commercialization. The collaboration will address the time it takes to develop a diagnostic and will offer flexible structures for diagnostic test alignment with therapeutic drug approval.
According to Sysmex, the partnership will leverage the companies' US PMA, European CE, Japanese PMDA, and APAC regulatory experience in accelerating companion diagnostic and therapeutic drug commercialization.
The companies also noted that additional parties may have the opportunity to join the collaboration in the future.
In October, Sysmex received 510(k) clearance from the US Food and Drug Administration for its UD-130 Fully Automated Urine Particle Digital Imaging Device for locating, digitally storing, and displaying microscopic images from urine samples.
China Association of In-vitro Diagnostics
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