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NIH Funding Single Home Test for Covid-19, Influenza, RSV

Co-Dx PCR Home test

Co-Dx PCR Home test (Co-Diagnostics Inc.)

14 July 2023. A developer of diagnostics for infectious and other diseases is receiving a National Institutes of Health contract to advance a single at-home test for multiple respiratory diseases. Co-Diagnostics Inc. in Salt Lake City, Utah was awarded $1.2 million from the Rapid Acceleration of Diagnostics or RADx program managed by the National Institute of Biomedical Imaging and Bioengineering, part of NIH.

Co-Diagnostics designs tests to detect diseases based on polymerase chain reaction or PCR methods, a genomic process for assessing specimen samples from individuals for their molecular composition. PCR tests take short genetic fragments called primers that representing segments of the genome, then quickly amplify or reproduce billions of copies of those fragments to enable high-speed analytic devices to determine the sequence of genes in the samples for genetic identification.

The Co-Diagnostics technology builds on basic PCR techniques with algorithms that the company says quickly run through millions of possible test options to find the best design for a particular diagnostic. The company’s technology, based on research by co-founder Brent Satterfield, produce longer probes allowing DNA strands to fold and rapidly bind to primer fragments. These cooperative primers, or CoPrimers as they’re called, reduce the formation of primer dimer molecules that can interfere with PCR amplification by blocking DNA from binding to primer fragments.

Detect multiple conditions in a single test

One of the company’s diagnostics devices in development based on the CoPrimers technology is the Co-DX PCR home testing platform. This device, says Co-Diagnostics, makes possible PCR testing, considered the gold-standard for genetic diagnostics, in the home, with results displayed on a companion smartphone app. Many of the current inexpensive home tests to detect Covid-19 infections seek out antigens in specimen samples, which are less sensitive than PCR tests and often require follow-up PCR testing to confirm the original screening.

Co-Diagnostics first developed the Co-DX platform for Covid-19 diagnostics. As reported by Science & Enterprise in Feb. 2023, the company began clinical evaluations of the Co-DX test, starting with Covid-19 detection, but with plans for expanding the tests to identify multiple respiratory diseases with a single test, called a multiplex test. Co-Diagnostics says NIH is helping fund further development of Co-DX to detect influenza type A or B and respiratory syncytial virus or RSV infections with Covid-19 in a single PCR test.

The new RADx award of $1.2 million, says Co-Diagnostics, supports expansion of the Co-DX upper respiratory panel to detect flu and RSV along with Covid-19 in its home testing device. The company says the funds come from the RADx Tech program, first offered as a challenge competition to encourage rapid development of home-based and point-of-care diagnostics for Covid-19.

“Our mission,” says Co-Diagnostics CEO Dwight Egan in a company statement, “to improve the quality of life through making high-quality, affordable diagnostics more available worldwide will be one step closer with the completion of this in-demand respiratory multiplex, which we believe meets the NIH’s standards for increased accessibility of next-generation testing as we navigate this post-pandemic landscape.”

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