Co-Diagnostics

Co-Diagnostics, Inc. operates as a molecular diagnostics company that specializes in the development, manufacturing, and marketing of advanced diagnostic technologies. It employs a distinctive approach to test development, using its CoPrimer technology. This technology excels in identifying and analyzing small molecules, enhancing accuracy, and minimizing errors in molecular diagnostics. As a result, it enables the concurrent detection of various conditions or genetic sequences. The company primarily employs this technology to design tests for diseases that have the potential to spread from person to person.

As of August 2023, the company had a lineup of seven in vitro diagnostic (IVD) products, most of which had obtained CE mark approval for sale in the EU and other relevant markets. These IVD offerings encompass a range of tests designed to identify genes associated with various viruses, including Influenza A, Influenza B, COVID-19, mycobacterium tuberculosis, Zika, all four serotypes of dengue, and chikungunya. Additionally, the company was actively working on the development of several diagnostic products intended for research purposes. This includes tests for Monkeypox and various processing techniques tailored for COVID-19 research applications.

Moreover, the company was advancing its Co-Dx PCR Home platform through clinical trials. This platform uses nucleic acid detection and analysis to develop tests for infectious diseases, including Covid-19. Distinguishing itself, this platform incorporates disposable cartridges and smartphone connectivity, making it an accessible option for home-based diagnostics. Anticipating progress, the company aimed to initiate the FDA approval submission process by late 2023.

In December 2021, the company acquired at-home COVID-19 platform providers, Idaho Molecular Inc. and Advanced Conceptions, Inc to strengthen its product portfolio. 

Key customers and partnerships

The company has several key partners: 1) Walgreens Find Care (February 2021) to provide customers PCR-based COVID-19 tests, 2) TiiCKER (December 2021) to reach new and existing investors, and 3) Dare Labs (October 2019) to set up a molecular diagnostics laboratory in Ghana.

Funding and financials

The company began trading on the Nasdaq in July 2017 under the ticker symbol “CODX,” raising USD 7.1 million at IPO. In July 2023, the company raised USD 1.33 million for tuberculosis (TB) and USD 0.99 million for human papillomavirus (HPV) tests in grants awarded by the Bill & Melinda Gates Foundation and received USD 1.2 million in funding from the National Institutes of Health (NIH) through the RADx Tech program. The funds received from NIH were used toward the development of the company’s flu A/B, Covid-19, and RSV multiplex test and preparation for clinical trials on the Co-Dx PCR Home platform. 

For the three months ended March 2023, the company achieved a revenue of USD 0.6 million (down from USD 22.7 million Q1 2022 due to lower demand for COVID-19 tests). It also reported a significant decline in net loss by 150% YoY to USD 11.7 million. Its cash and cash equivalent as of March 2023 was at USD 75.3 million.