Co-Diagnostics has started clinical evaluations for its Co-Dx PCR Home platform, developed to detect infectious diseases, and an initial Covid-19 test.
The company developed the real-time PCR platform to detect infectious diseases in point-of-care as well as at-home settings.
The evaluations will include trials and analytical studies that could support submissions to the US Food and Drug Administration (FDA) and other regulatory authorities.
Multiplex panels are expected to follow after the platform receives initial regulatory authorisation.
The company will not provide a projected completion timeline, as the assessments depend on the identification and enrolment of a certain number of symptomatic as well as asymptomatic Covid-19-positive and -negative patients at testing centres.
Co-Diagnostics CEO Dwight Egan said: “It is the culmination of a development process that spans over two years of research and development and has harnessed the expert skills of well over a hundred dedicated scientists, engineers and support staff.
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“The new at-home and point-of-care testing (POCT) platform represents a high degree of innovation that brings together the power of our patented Co-Primer technology coupled with other proprietary IP, setting a new standard for compact POCT that unlocks the multiplexing potential of real-time PCR.
“We believe this invention holds significant promise for the US and around the world, including regions of the globe that have not previously had access to the quality-of-life advantages of inexpensive, powerful, accurate diagnostic technology.”
Leveraging its technology, Co-Diagnostics can design specific tests for its Co-Dx PCR Home platform as well as locate specific genetic markers.
The platform uses disposable cartridges and smartphone connectivity to provide gold-standard PCR testing in offices, homes and schools.