Record Revenue Growth
Q1 revenue of $697 million, up 39% year-over-year, driven by strong volume and ASP expansion.
Unit Milestone — 1 Million Units in a Quarter
First quarter in which the company processed 1 million units in a single quarter, demonstrating large-scale volume execution.
Oncology (Signatera) Volume Surge
Processed 249,000 clinical oncology (MRD) units in Q1, a 55% year-over-year increase and ~24,000 units above Q4; implies an MRD run rate of over 1 million tests annually.
Fetal Focus Launch and Women's Health Momentum
Fetal Focus launch exceeding expectations with an approaching annualized run rate of nearly 200,000 orders; core women's health added ~63,000 units quarter-over-quarter (Q4 2025 to Q1 2026).
Pricing and ASP Improvement
Realized ASPs increased across businesses; Signatera ASP reached roughly $1,250 and company reiterated a long-term ASP target of $2,000 per test (which management estimates could translate to ~ $750M incremental revenue at current volumes).
Gross Margin Outperformance and Guidance Raise
Q1 gross margin just under 65%, exceeding prior midpoint guidance (64%); company reset full-year revenue guide up by more than $120 million at the midpoint and raised gross margin guidance to 65% at the midpoint.
Clinical and Publication Momentum
Multiple high-impact data readouts and publications (including bladder cancer data in NEJM and EXPAND trial results), 35 ASCO abstracts planned and broad evidence across tumor types reinforcing Signatera's clinical utility.
Accelerated Trial Enrollment and R&D Investment
Enrollment for oncology trials and FIND CRC is ahead of schedule; company increased R&D expectations by $50 million to pull forward trials and expects FIND CRC enrollment complete by Q3 2026 (PMA path for 2027).
Japan Commercial Opportunity
PMDA approval for Signatera on track for Q2 2026 with launch preparations underway; prior use across 150+ institutions and supportive guidelines could materially expand TAM (Japan CRC opportunity could double Signatera's CRC volume TAM).
Strategic Integration and Product Enhancements
Integration of Foresight Diagnostics progressing well; phased-variant technology and an updated Signatera genome-based assay (with phased variants) planned for clinical availability later this year, with early pharma/research uptake.