At the peak of the pandemic’s madness, not all Utah companies suffered. It was quite the opposite case for a few emerging biotechnology innovators, one of them being Co-Diagnostics (Co-Dx). Based in Salt Lake City, Co-Dx was built to disrupt the molecular diagnostics marketplace. Since its formation in 2013, the company has delivered various tests and products in 50 different countries worldwide. And with the state of urgency pressed against the world amid Covid, Co-Dx rose to the challenge and surpassed $100 million in revenue in 2021.
With glimmers of hope shimmering on the horizon of the Covid wake, Co-Dx looks toward its future beyond Covid detection and into a wide range of infectious disease conditions chronically plaguing individuals worldwide. Co-Dx can do this by harnessing a technology called polymerase chain reaction, or PCR, one of the most ubiquitous molecular amplification techniques in research laboratories and healthcare clinics worldwide.
Kary Mullis invented the PCR technique in 1985 while working as a chemist at the Cetus Corporation, a biotechnology firm in Emeryville, California. This procedure uses an alternating temperature cycling system and specific reagents to detect the presence of specific DNA strands in a small sample (e.g., from a swab) and sequence them to a level that allows for confident determination of the exact identity and origin of that DNA.
Co-Dx’s proprietary YouTest PCR system not only allows you to identify a specific DNA molecule’s origin—rather, it allows you to “multiplex” the analysis by detecting several different origins simultaneously in a single swab sample.
For example, it is quite common for individuals suffering from a microbial infection to be simultaneously colonized by multiple infectious strains that are concomitantly wreaking havoc in the body. This can pose a particular problem, especially when different treatment protocols may exist for the different invading microbes. Sometimes, the treatment of one of the infections will do nothing to help and may even allow for the continued spread of the others.
Co-Dx’s YouTest PCR would be able to confidently identify all of these infectious agents, allowing for more targeted therapeutic strategies and treatment plans to alleviate the burden of disease.
The YouTest PCR system is already actively deployed worldwide in various locations, delivering this multiplexed diagnostic approach for infection identification for common diseases such as influenza virus, malaria, hepatitis B and C, and other sexually transmitted infections.
For perspective, let’s take a look at some annual average global infection rates of these microbes. Each year, there are close to 700 million cases of influenza virus infection worldwide, close to 400 million cases of sexually transmitted infections, and just over 200 million cases of malaria. As of this article’s writing, there are 431 million confirmed cases of Covid worldwide from the time of the pandemic’s inception.
Infectious disease will only continue to be a burden on our healthcare systems worldwide, compounding with the insurgence of antimicrobial resistance patterns spreading like wildfire throughout the globe.
Co-Dx’s ability to bring multi-infection detection systems to the worldwide marketplace will likely aid in the proper diagnosis and treatment strategies for literally billions of people. This is a hard mark to surpass for any Fortune 500 company, let alone a local start-up biotechnology company along the Silicon Slopes.
Of course, Co-Dx still has some important milestones to overcome before this becomes a reality. First, the YouTest PCR system needs to gain FDA approval. Fortunately, Co-Dx has placed its resources in acquiring Idaho Molecular Inc. and Advanced Conceptions, Inc. to further the development of at-home/point-of-care molecular diagnostic devices such as the YouTest platform. The deal cost Co-Dx over $40 million, so there must have been some very stark benefits readily seen in the upcoming years by Co-Dx CEO Dwight Egan.
“For nearly a year now, we have had the honor of working with some of the greatest minds in PCR device development, and we are pleased to be able to announce that with this merger, they will become part of the Co-Dx family,” Egan says. “We believe that this acquisition immediately increases the company’s value and will allow for greater efficiency when developing future product iterations and as we begin principle and large-scale manufacturing of the device and initial Covid test, all with the additional financial benefit of allowing commercialization of these groundbreaking products without royalties or restrictions."
As the world looks onward and upward past the chaos and calamity of Covid, we look forward to brighter diagnostics futures with multi-infection detection systems driven by innovations such as Co-Dx’s emerging tech.