Co-Diagnostics, Inc.

What they do

Co-Diagnostics develops, manufactures and sells reagents for nucleic acid (DNA/RNA) diagnostic tests, using its patented Co-Primers PCR primer/probe design intended to reduce primer-dimer false positives. Its approved tests cover COVID-19, influenza, tuberculosis, hepatitis B and C, HPV, malaria, chikungunya, dengue and Zika, cleared for clinical laboratory use only. It is separately developing the Co-Dx PCR platform, a portable PCR instrument, test cup system and mobile app aimed at point-of-care and at-home use, which remains subject to FDA review and is not for sale.

Revenue drivers

• Clinical lab PCR test reagents (Logix Smart and related tests) — The company sells reagents for its CE-marked and otherwise approved infectious disease tests through a global distributor network; this is the only currently commercialized revenue source. Revenue has collapsed from pandemic levels to under $0.7 million annually in 2025.
• Vector Smart vector surveillance — A decentralized mosquito/vector surveillance platform that management says expanded to a customer footprint of 21 U.S. states in Q2 2026, with four new mosquito abatement district laboratory installations completed in the quarter. No revenue figure for this line is disclosed in the excerpts.
• Co-Dx PCR platform (not yet revenue-generating) — The instrument, test cup and mobile app system is not available for sale and remains subject to FDA review, so it produces no revenue today. Management positions it as the core future commercial platform.
• International manufacturing and distribution (CoMira in Saudi Arabia, CoSara) — The company is building localized production and distribution in the MENA region through CoMira Diagnostics and in India through CoSara. These are preparatory investments, not disclosed revenue contributors.

Recent performance

Second quarter 2026 revenue was $0.17 million versus $0.16 million in the second quarter of 2025, driven by higher product revenue. Operating expenses fell to $6.3 million from $8.2 million, producing an operating loss of $6.2 million versus $8.1 million a year earlier. Net loss was $6.3 million, or $1.46 per basic and diluted share, compared to a net loss of $7.7 million, or $7.00 per share, in Q2 2025, and adjusted EBITDA loss narrowed to $5.8 million from $7.2 million. Cash and cash equivalents were $3.6 million as of June 30, 2026. Full-year 2025 revenue was $622,489 with a net loss of $47.0 million, and quarterly revenue has stayed near $145,000–$264,000 over the last four quarters.

Strategy

Management is concentrating development and clinical validation on the Co-Dx PCR Flu A/B, COVID-19, RSV multiplex test (ABCR) after voluntarily withdrawing its June 2024 510(k) for the COVID-19 test. Per the August 2026 earnings release, the company submitted an FDA 510(k) for the Co-Dx PCR Flu A/B & RSV upper respiratory multiplex test on the Co-Dx PCR Pro instrument. It is expanding international manufacturing and commercialization, including a Saudi-approved industrial site and lease in Sudair Industrial City through CoMira Diagnostics, a Mexican distribution agreement, and TB program work in India. The company funded itself partly through a $3.0 million private placement and describes an integrated platform combining instrumentation, assays, cloud connectivity and AI.

Risks

• No approved point-of-care product — The Co-Dx PCR platform is not available for sale, and the company voluntarily withdrew its initial COVID-19 510(k) after FDA discussions about detecting degradation of a test component over shelf life.
• Persistent losses and cash burn — Net loss was $47.0 million in 2025 and operating cash flow was negative $29.1 million, while revenue was only $0.62 million and cash stood at $3.6 million at June 30, 2026.
• Thin capitalization and dilution — Shareholder equity was $12.7 million at June 30, 2026, and the company raised $3.0 million in a private placement in the second quarter, with further equity raises likely if losses continue.
• Revenue concentrated in legacy clinical lab tests — Revenue is almost entirely from clinical-lab-only reagents that have declined from $97.9 million in 2021 to $622,489 in 2025, with no disclosed large new commercial contributor.

Outlook

Management says it is advancing the ABCR/upper respiratory multiplex test toward commercialization, with an FDA 510(k) submitted for the Co-Dx PCR Flu A/B & RSV test on the PCR Pro instrument, and clinical performance studies underway for ABCR. It plans continued investment in international manufacturing, including Saudi Arabia and India, and in expanding Co-Dx PCR platform distribution in Latin America. The 10-K states there is no guarantee the platform will receive regulatory approval or be successfully commercialized.