Co-Dx PCR Home test (Co-Diagnostics Inc.)
22 Feb. 2023. A company offering DNA analysis tests to detect infectious diseases at home and point-of-care is beginning clinical evaluations of its technology. Co-Diagnostics Inc. in Salt Lake City, Utah says a series of clinical trials and analytical studies are assessing the company’s Co-Dx PCR Home platform, to prepare for regulatory submissions in the U.S. and elsewhere.
Co-Diagnostics develops tests for detecting disease using the polymerase chain reaction or PCR technique. PCR tests analyze biological specimen samples to identify DNA sequences in the samples. The technique selects a segment of DNA in the sample with short synthetic fragments of DNA called primers, then the fragments are synthesized and multiplied to amplify the segment for analysis. PCR today is a basic genomic technique and considered the gold-standard for DNA analysis.
The company’s technology is based on research by Co-Diagnostics’ co-founder Brent Satterfield for vastly improving the output of PCR. Satterfield, a scientific advisor to Co-Diagnostics, earlier devised a process for reducing the formation and proliferation of molecules in the PCR process called primer dimers that block the binding of DNA to primer fragments and interfere with amplification. The result is what Satterfield calls cooperative primers or CoPrimers that use longer probes to allow DNA strands to fold and quickly bind to primer fragments, then release a fluorescing chemical signal. Satterfield and the company say the CoPrimer process improves PCR amplification of DNA by some 2.5 million times.
Begins with detection of Covid-19
Co-Diagnostics says it packages the technology with supporting algorithms for clinical and research use. Among its applications is a portable self-contained diagnostic system for infectious diseases called the Co-Dx PCR home testing platform that connects with a smartphone to display results. This system, says the company, is designed for use at home and point-of-care clinics that can be in locations remote from labs with PCR equipment.
The company says it’s beginning clinical evaluations of the Co-Dx PCR home system with detection of Covid-19 infections, but Co-Diagnostics plans to expand the system’s capabilities to allow for detection of multiple pathogens. The company says it expects to enroll Covid-19 positive and negative participants in clinical trials, both with and without symptoms, but further details are not disclosed.
In a company statement, Co-Diagnostics CEO Dwight Egan calls the start of clinical assessments “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.” Egan adds, “We believe this invention holds significant promise for the United States 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.”
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