Co-Diagnostics (Co-Dx) has signed a definitive agreement with Arabian Eagle Manufacturing to create a joint venture (JV), CoMira Diagnostics, for polymerase chain reaction (PCR) platform distribution.
The JV will engage in the research, development, distribution and marketing of Co-Dx’s technologies and intellectual property (IP), including the PCR point-of-care platform, within the Kingdom of Saudi Arabia (KSA) and 18 additional nations in the Middle East and North Africa (MENA) region.
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The companies plan to seek regulatory clearance from the Saudi Food & Drug Administration (SFDA) as a strategic step to facilitate market entry across the broader territory.
Arabian Eagle, which led the primary distribution of Co-Dx’s Logix Smart tests in the Middle East, will contribute to the JV by overseeing the establishment of a manufacturing facility, managing regulatory approvals, and ensuring compliance with local laws.
Under the JV agreement, Co-Dx will equip the JV with an exclusive licence to utilise, produce, and market the licensed IP, encompassing the forthcoming PCR platform and existing laboratory-based diagnostic products.
Co-Diagnostics CEO Dwight Egan said: “We are pleased to announce this agreement to establish the relationship with Arabian Eagle, our valued partners in the Middle East, as we expand the reach of our exciting healthcare innovations into a region with a large and growing market for medical devices and point-of-care diagnostics.
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By GlobalData“The KSA has published the key demand drivers that underpin that anticipated growth, and we believe that our cutting-edge PCR technology, along with the scope and mission of CoMira, addresses those drivers while reinforcing our resolve to close the accessibility gap between high-quality PCR diagnostics and those who need them.”
CoMira is preparing to initiate clinical assessments for tuberculosis, multiplex tests for Covid-19, influenza A and B, RSV, and an 8-type HPV multiplex test before the end of this year.
The Co-Dx PCR platform, which comprises the PCR Pro, PCR Home, mobile app and associated tests, is not yet available for sale and is pending clearance from the US Food and Drug Administration (FDA) and other regulatory authorities.
