New Platform Technology Transforming Healthcare with Affordable, On-Site PCR Testing

Traditionally, PCR has been the gold standard for diagnosing most infectious diseases, a process confined to the expertise of specialized lab personnel. Now, a new platform for on-site infectious disease multiplex testing simplifies this process, enabling users to conduct PCR diagnostics at the point of need with as much ease as updating their social media status.

Co-Diagnostics, Inc.’s (Salt Lake City, Utah, USA) Co-Dx PCR Pro instrument brings the precision of real-time PCR directly to the point of care, offering results in minutes. This eliminates the traditional dependence on laboratory analysis and the associated delays in sample transportation, while also mitigating the risk of sample mishandling or loss during transit. The device is designed for ease of use, connecting to smartphones or tablets, thereby enhancing accessibility for various users. The convenience of conducting on-site multiplex testing not only saves time but also reduces laboratory expenses. With the Co-Dx PCR Pro, healthcare facilities can make immediate, informed decisions based on reliable PCR test results obtained on-site.

Co-Diagnostics has submitted its Co-Dx PCR COVID-19 test alongside the Co-Dx PCR Pro instrument to the U.S. Food and Drug Administration for Emergency Use Authorization review. This submission includes the PCR Pro instrument, the COVID-19 detection test, and a mobile application tailored for both point-of-care and home use. The Co-Dx COVID-19 test kit, designed for the PCR Pro instrument and included in the company's FDA submission, has demonstrated its efficacy in detecting COVID-19 from anterior nasal swab samples in clinical evaluations. It delivers results directly to the user's smartphone or other mobile devices in roughly 30 minutes. Co-Diagnostics is also developing a broader spectrum of tests for this innovative platform, including diagnostics for tuberculosis, human papillomavirus, and a comprehensive upper respiratory panel that simultaneously identifies influenza A/B, COVID-19, and respiratory syncytial virus from a single sample.

"This new platform technology is a significant step towards advancing the Company's mission to increase accessibility of PCR diagnostics," said Dwight Egan, CEO of Co-Diagnostics. "In addition to the development of new technologies from the ground-up by a world-class team to decentralize PCR diagnostics technology and make it available at the point-of-care and in at-home settings, it also required the new technology to be able to be commercialized at a price point that is relevant worldwide. Diagnostics, along with vaccines and therapeutics, are a vital tool in helping to combat illnesses like TB, which remains a significant problem in India and many other countries despite being a highly treatable disease. We are pleased to announce this submission to the FDA for this new platform."

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