SALT LAKE CITY – Co-Diagnostics, Inc. (NASDAQ:CODX), a molecular diagnostics company, announced the completion of its first U.S. Food and Drug Administration (FDA) 510(k) filing for its Co instrument -Dx™ PCR Pro™ and the Co-Dx PCR COVID-19 test for over-the-counter (OTC) use.
The application, submitted through the FDA’s electronic Submissions Template And Resource (eSTAR) system, was recognized by the FDA. The Co-Dx PCR platform aims to expand access to PCR diagnostics, traditionally available in complex clinical laboratories, to the point of care and at home through an easy-to-use smartphone interface.
Dwight Egan, CEO of Co-Diagnostics, said this FDA request marks a significant step in the company’s growth and making advanced diagnostics more accessible. The company expects 510(k) clearance to confirm the quality of the platform as it plans to extend the technology to other indications and regions.
In addition to the OTC COVID-19 test, Co-Diagnostics is preparing to apply for authorization for the same test for point-of-care use. The company’s pipeline also includes diagnostics in development for tuberculosis, human papillomavirus, strep A, and a multiplex respiratory test capable of simultaneously detecting influenza A and B, COVID-19, and RSV.
The Co-Dx PCR platform, which includes PCR Home™, PCR Pro™, the mobile application and all associated tests, is currently under review by the FDA and is not yet available for sale. The company is moving forward with initiating clinical evaluations and submitting applications for these tests in their respective target markets.
Utah-based Co-Diagnostics specializes in the development, manufacturing and marketing of diagnostic technologies for the detection and analysis of DNA or RNA nucleic acid molecules. The company’s proprietary technology is also used to design tests specifically for its Co-Dx PCR platform.
The information in this article is based on a press release from Co-Diagnostics.
In other recent news, Co-Diagnostics, Inc. reported its first quarter 2024 financial results, revealing a decrease in total revenue to $0.5 million, compared to $0.6 million a year earlier. The company also revealed a net loss of $9.3 million, up from a net loss of $5.8 million a year earlier. In strategic developments, Co-Diagnostics is nearing completion of its 510(k) submission to the FDA for the Co-Dx PCR Pro and COVID-19 Kit.
Additionally, the company expanded its manufacturing capabilities with the opening of a new manufacturing facility in Salt Lake City. These are some of the company’s recent developments, as it continues to focus on the commercialization of its Co-Dx PCR platform and the development of tests for tuberculosis, HPV and upper respiratory infections. To support these efforts, the company has also increased investment in research and development. Despite the widening net loss, Co-Diagnostics maintains a strong liquidity position and is focused on operational efficiency ahead of the expected platform launch.
Insights from InvestingPro
In light of Co-Diagnostics’ recent FDA filing for its Co-Dx™ PCR platform, investors are closely monitoring the company’s financial health and market performance. According to data from InvestingPro, Co-Diagnostics currently has a market capitalization of $53.14 million. The company’s aggressive share repurchase strategy, as per an InvestingPro tip, underlines management’s confidence in the company’s value proposition. Additionally, Co-Diagnostics has managed to keep more cash than debt on its balance sheet, which may be a positive sign of financial stability in the volatile biotech sector.
Despite these strengths, the company’s price-to-earnings (P/E) ratio stands at -1.22, with a trailing twelve month adjusted P/E ratio to Q1 2024 of -1.29, demonstrating the challenges the company faces in achieving profitability. The company’s revenue declined 44.91% over the trailing twelve months as of Q1 2024, in line with another InvestingPro tip that analysts expect sales to decline in the current year. Furthermore, the company’s operating income margin for the same period stood at -644.14%, indicating substantial operating expenses relative to revenue.
Nonetheless, investors have seen a significant comeback over the past week, with the stock price rising 25.92%. This short-term performance, combined with a strong return over the past year of 63.45%, could attract traders looking for momentum strategies. With these insights, interested parties may consider exploring other InvestingPro tips, which include 15 more Co-Diagnostics tips, available at https://www.investing.com/pro/CODX. For those who want to delve deeper into the company’s financials and market forecasts, use the coupon code PRONEWS24 to get an additional 10% discount on a one-year or two-year Pro and Pro+ subscription to InvestingPro.
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