Revenue Growth Year-over-Year
Total revenue for Q1 2026 was $146,000, up from $50,000 in Q1 2025, an increase of approximately 192% YoY, demonstrating early commercial traction despite low absolute dollar levels.
Upper Respiratory Clinical Enrollment Completed (>1,400 Patients)
Clinical study enrollment for the upper respiratory multiplex test exceeded 1,400 patients. Management believes the data supports an initial 510(k) submission focused on Flu A, Flu B and RSV and is preparing to file for CLIA-waived point-of-care clearance, targeted for Q3 2026 (subject to validations).
India (CoSara) Regulatory and Manufacturing Progress
CoSara has a nationwide commercial presence, has served hundreds of laboratory customers, holds 15 clinical PCR test clearances from CDSCO, received a CDSCO license to manufacture the PCR Pro instrument, and has expanded distribution across South Asia increasing the total addressable market to about $13 billion.
TB Program Advancement and Alignment with WHO Guidance
Clinical performance studies for the MTB (TB) test are scheduled to begin before month-end; management expects potential commercialization in India as early as end of Q3 2026. The test design aligns with recent WHO recommendations for near point-of-care molecular TB testing and tongue swab samples.
Saudi Arabia (CoMira) Expansion Milestone
CoMira secured industrial land allocation in Sudair Industrial City, progressed facility lease and site development, and completed initial required funding contributions, positioning the JV for localized manufacturing and potential procurement advantages in the MENA region.
Manufacturing Capacity and Automation Improvements
Utah facility has produced hundreds of thousands of test cups for studies and R&D and is developing an automated test cup manufacturing line expected to improve efficiency by ~4x in time and overhead, reducing manual steps and potential errors.
Platform and Pipeline Diversification
Continued advancement of non-TB programs (HPV in preclinical/qualification, expanding Vector placements), cloud-connected architecture with ML/algorithmic capabilities, and ongoing automation in consumable production, supporting broader use cases and scalability.