Eduardo Martinez-Montes's questions to Co-Diagnostics (CODX) leadership • Q2 2025
Question
The analyst inquired about the specific timelines for clinical trials and regulatory submissions for the company's four key diagnostic tests. He also asked about the prioritization of these submissions and the company's strategy for commercial launch, including target markets, timing, and distribution plans.
Answer
Management stated that all four tests (COVID-19, multiplex, TB, HPV) are expected to enter clinical trials within the 2025 calendar year, starting with the COVID-19 test. They anticipate a US commercial launch for the COVID-19 test around mid-2026, following FDA submission and review. The commercial strategy for the US includes point-of-care settings, pharmacies, and home use, while the TB and HPV tests are targeted for international markets like India and Africa.