Co‑Diagnostics has begun clinical performance testing for a new upper‑respiratory multiplex assay that simultaneously detects influenza A, influenza B, COVID‑19 and RSV on its Co‑Dx PCR Pro instrument. The test is part of the company’s portable, low‑cost Co‑Dx PCR platform designed for point‑of‑care and at‑home use.
The performance data will support a 510(k) submission to the U.S. Food and Drug Administration for clearance of both the multiplex assay and the instrument. The test is not yet available for sale and remains subject to regulatory review, underscoring the regulatory risk and the importance of successful clearance for commercialization.
The respiratory infectious‑disease diagnostics market was valued at $54.58 billion in 2024, with molecular diagnostics accounting for roughly two‑thirds of that value. North America is the largest market, and the platform’s point‑of‑care focus aligns with a projected global market growth to $73.56 billion by 2030, highlighting the commercial potential of the new test.
Co‑Diagnostics’ recent financial results show a sharp decline in revenue to $150,000 in Q3 2025, down from $600,000 in Q3 2024, driven largely by a reduction in grant revenue. The company reported a net loss of $5.9 million in Q3 2025 versus $9.7 million in Q3 2024, indicating a narrowing of losses but a significant revenue contraction. The company has been raising capital through registered direct offerings to support its operations.
CEO Dwight Egan emphasized that regulatory clearance and commercialization of the Co‑Dx PCR platform remain the company’s primary objectives. He noted the strategic importance of the CoSara Diagnostics joint venture in India and the potential SPAC transaction for the venture, while also highlighting the launch of a dedicated AI business unit to integrate artificial intelligence into the Co‑Dx Primer Ai platform.
Investors reacted negatively to the Q3 2025 earnings release, citing the revenue miss against analyst expectations of $153,000 and the continued net loss. The revenue shortfall, combined with the company’s ongoing financial challenges, has dampened enthusiasm for the product development announcement, even as the company positions itself to capture demand in emerging markets.
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