Co-Diagnostics Moves Closer to Commercial Tuberculosis Test Launch in India

Co-Diagnostics' India joint venture, CoSara, submitted its tuberculosis test for regulatory review in India, reporting 97.3% sensitivity and 96.0% specificity. The test, using Co-Diagnostics' technology, aims for approval by Q4 2026 to begin sales in India and South Asia. India has the highest tuberculosis burden globally, according to the WHO.

Co-Diagnostics' joint venture CoSara Diagnostics completed a clinical study for its tuberculosis test, reporting 97.3% sensitivity and 96.0% specificity. The test was submitted to India's CDSCO for regulatory clearance, with a commercial launch anticipated before year-end 2026. The company has also deployed mobile and cloud infrastructure in India to support the launch.

Co-Diagnostics (Nasdaq: CODX) reported Q2 2026 results for the quarter ended June 30, 2026. Revenue was $0.17M vs $0.16M a year earlier. Operating loss was $6.2M, net loss $6.3M ($1.46/share). Cash was $3.6M. The company said it completed studies and submitted a 510(k) for its Flu A/B and RSV multiplex test, and raised $3.0M via private placement.

Co-Diagnostics, Inc. (CODX) filed an SEC Form 8-K — Results of Operations and Financial Condition. Exhibit 99.1 Co-Diagnostics Reports Second Quarter 2026 Financial Results Advancing Commercialization Through FDA Submission, Global Clinical Progress and Manufacturing Expansion Strengthening Integrated Co-Dx PCR Platform Through Scientific Innovation, Cloud Connectivity and AI-

Co-Diagnostics (Nasdaq: CODX) reported Q2 2026 revenue of $0.17 million, up from $0.16 million a year earlier, with a net loss of $6.3 million ($1.46/share) versus a $7.7 million loss in Q2 2025. Cash fell to $3.6 million from $11.9 million. The company said it completed studies for an FDA 510(k) and CLIA waiver for its Flu A/B & RSV PCR test and raised $3.0 million in a private placement.

Co-Diagnostics (Nasdaq: CODX) said it submitted a Dual 510(k) premarket notification with a concurrent CLIA Waiver by Application to the FDA for its Co-Dx PCR Flu A/B & RSV upper respiratory multiplex test on the Co-Dx PCR Pro instrument. The filing follows clinical studies of 1,400 symptomatic patients and analytical work across 27 studies and 10,000+ PCR runs. If granted, the CLIA waiver would enable decentralized point-of-care use; the platform is not yet for sale.