Revenue Above Guidance and Sequential Growth
Q1 total revenue of $27.9 million, which came in above the midpoint of guidance and grew 4% sequentially.
Diagnostics Segment Strength
Diagnostics revenue of $16.9 million in Q1, with an approximately even split between U.S. and international sales and sequential growth of 12%.
Gross Margin Expansion
GAAP gross margin improved to 42.3% (from 41.1% in Q1 2025, +1.2 percentage points) and non-GAAP gross margin rose to 43.4% (from 41.7% in Q1 2025, +1.7 percentage points), driven by in-sourcing production and manufacturing efficiencies.
Strong Balance Sheet and Capital Returns
Ended the quarter with $177 million in cash and cash equivalents, zero debt, and continued share repurchases (deployed $5 million in Q1 for 1.8 million shares and $20 million repurchased over the last four quarters).
Near-Term Product Catalysts
Two FDA submissions in active review with anticipated midyear clearances: an OTC rapid molecular self-test for CT/NG on the Sherlock platform and the Colli-Pee at-home urine collection device. Management expects revenue from these launches to ramp in the second half of 2026.
International Near-Shoring and Market Expansion
Delivered initial orders to a near-shoring partner in Africa during Q1, expect additional initial orders from other partners in H2 2026, and are integrating BioMedomics and expanding SickleSCAN into new national health program markets—management referred to potential opportunity sizes in the 'millions.'
Focused R&D Investment with Planned Taper
R&D investment increased to $13.7 million in Q1 due to launch and production readiness activities for CT/NG and Colli-Pee, with management expecting R&D expense to taper in Q2 and Q3 as launch preparations conclude.