Co-Diagnostics Navigates Post-Pandemic Shift, Faces Doubts About Going Concern

NEW YORK, NY – November 13, 2025

A Difficult Transition for Diagnostics Firms

The molecular diagnostics sector is undergoing a significant recalibration following the surge in demand for COVID-19 testing. Companies that rapidly scaled up production to meet pandemic-era needs are now grappling with a steep decline in revenue and increasing pressure to innovate and find new growth avenues. Co-Diagnostics, a molecular diagnostics company focused on infectious disease testing, is facing these challenges head-on, reporting continued net losses and implementing strategic shifts in its financial reporting and operational focus. The company’s recent financial results for the third quarter of 2024, and subsequent reports from Q3 2025, paint a picture of a business struggling to adapt to a new normal.

Financial Performance and a New Metric

Co-Diagnostics reported a net loss of $9.7 million for the third quarter of 2024, a significant increase compared to the $6.0 million loss reported in the same period last year. Revenue also declined sharply, falling from $2.5 million in Q3 2023 to just $0.6 million in Q3 2024. While the company attributes this decline to the timing of grant revenue recognition, the underlying trend is undeniably downward. More recently, Q3 2025 results revealed an even steeper decline in revenue, dropping to $0.1 million, with a net loss of $5.9 million.

In an effort to provide investors with a clearer picture of its underlying business performance, Co-Diagnostics introduced Adjusted EBITDA as a non-GAAP metric. The company defines Adjusted EBITDA as net income excluding several items, including depreciation, amortization, stock-based compensation, and other one-time expenses. For Q3 2024, the Adjusted EBITDA loss was $8.8 million, compared to $6.5 million in the prior year. However, the use of this metric has raised questions about transparency and whether it accurately reflects the company’s financial health. “Non-GAAP metrics can be useful tools for investors, but they can also be manipulated to present a more favorable picture,” says one financial analyst. “It’s crucial to carefully examine the adjustments being made and understand the rationale behind them.”

Adding to the concern, the company’s Q3 2025 SEC filing explicitly states that management has “substantial doubt about the ability to continue as a going concern for 12 months.” This suggests that Co-Diagnostics is facing a serious liquidity crisis and may struggle to remain operational without significant financial intervention.

Beyond COVID-19: A New Product Pipeline and Strategic Expansion

Recognizing the need to diversify its revenue streams, Co-Diagnostics is focusing on developing a robust pipeline of new products beyond COVID-19 testing. The company is currently working on 32 tests in the in vitro diagnostics market, with a primary focus on infectious diseases, followed by cancer, cardiovascular diseases, genetic disorders, and immune system diseases. Key tests in development include a 4-plex respiratory panel, a tuberculosis (TB) test, and an HPV 8-type multiplex panel.

“The company is trying to position itself for the future by investing in new technologies and expanding its product portfolio,” explains a healthcare consultant. “However, developing and commercializing these new tests will require significant time and investment.” The company is also betting on its Co-Dx PCR point-of-care platform, a portable diagnostic device designed for rapid and accurate testing, including for at-home use. Despite a setback with the initial FDA application due to stability concerns, the company plans to resubmit after gathering further clinical data.

To accelerate its growth and expand its reach, Co-Diagnostics is pursuing strategic partnerships and international expansion. The company has established joint ventures with CoSara in India and CoMira in Saudi Arabia, aiming to expand its presence in these key markets. An oligonucleotide manufacturing facility in India is also nearing completion, which is expected to enhance the company’s manufacturing capabilities and reduce costs. Furthermore, Co-Diagnostics is investing in artificial intelligence, establishing an AI business unit to integrate AI applications into its diagnostic platform, potentially improving efficiency and accelerating the development of new tests. “The AI initiative is a bold move,” says a technology analyst. “If successful, it could give Co-Diagnostics a significant competitive advantage.”

Despite these efforts, the path forward remains challenging for Co-Diagnostics. The company faces intense competition from established players in the molecular diagnostics market and must navigate a complex regulatory landscape. The financial outlook remains uncertain, and the company's ability to continue as a going concern is in question. However, with a focused strategy, a robust pipeline of new products, and strategic partnerships, Co-Diagnostics may be able to weather the storm and emerge as a viable player in the evolving diagnostics market.