New Rapid PCR POC Testing Platform Could Provide Affordable COVID-19 Surveillance, Screening and Diagnoses

A new rapid point-of-care and at home PCR diagnostic testing, screening and surveillance platform is being designed to perform COVID-19 testing at businesses, schools, homes, hotels, cruise ships, airports, airplanes and other locations.

The proprietary platform includes a countertop device being developed for Co-Diagnostics, Inc. (Salt Lake City, UT, USA) by world experts in rapid PCR. The small cube-shaped device utilizes the company's Direct Saliva extraction-free protocol in connection with Logix Smart test reagents that are pre-packaged in saliva receptacle tubes. A person simply adds a swab or saliva sample to the receptacle tube and places the tube inside the device, which is then activated via a smartphone app and delivers rapid PCR COVID-19 results directly to the smartphone. The company believes that the convenience of displaying testing results on the smartphone empowers employees, students, travelers, and other individuals to quickly know their COVID-19 status, and may also provide a simple, straightforward way to satisfy requirements for entry into entertainment venues, clearance for airplane travel and hotel accommodations, work and school passports, and other applications.

The platform chemistry was created by Co-Diagnostics utilizing proprietary CoPrimer technology, Direct Saliva extraction-free protocols, and freeze-dried reagents. The device is being developed and engineered for Co-Diagnostics by internationally renowned experts in rapid PCR applications, and whose previous medical device inventions are in widespread use around the world.

With this platform, Co-Diagnostics plans to revolutionize the availability of accurate, fast and economical PCR tests as regular COVID-19 testing becomes part of the long-term protocol for many organizations. The rapid gold-standard PCR results from this testing platform would be differentiated from less accurate antigen tests. In addition, PCR may even detect the presence of genetic material of the SARS-CoV-2 virus being carried by vaccinated patients. The company agrees with epidemiologists that the rapid spread of the coronavirus and appearance of mutant strains mean that COVID-19 will remain with us for years, or even decades, leaving the world population to coexist with COVID-19 similar to other endemic diseases like flu, the common cold, and HIV.

The company expects that this planned elegant new platform will ultimately provide affordable COVID-19 PCR surveillance, screening and diagnoses to augment tests performed in high-complexity laboratory settings. While it is being designed for in-home use by responsible individuals, it is anticipated that businesses, physician's offices, dental offices, schools, theaters, sporting arenas, hotels, airlines and many other locations will avail themselves of the ease, accuracy and accessibility of this testing platform. The company expects that other tests will also become available on the device such as strep A, RSV, influenza A and influenza B, and potentially any other pathogen that can be sampled from a patient using saliva or a swab. It is expected that the new platform will be available for submission for regulatory approval later this year.

"The company has always envisioned ultimately developing a point-of-care/at-home diagnostic device making PCR accessible at affordable prices worldwide, and we are pleased that the culmination of years of development has resulted in a realization of this vision," said Co-Diagnostics CEO Dwight Egan. "Along with vaccines, social distancing with masks, and high-throughput laboratory testing, we believe that the wide-spread availability of this testing platform will truly give individuals the power to know their COVID-19 status so the world can get back to work, school, travel and vacations in a COVID-safe environment."

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