Detailed Narrative
Q1 Performance Highlights
Natera reported Q1 revenue of $697 million, a 39% increase year-over-year, driven by strong volume growth across all segments. The company achieved a milestone of delivering 1 million units in a single quarter, with oncology units growing 55% year-over-year to 249,000. Gross margins reached 65%, exceeding previous guidance, despite a temporary 2 percentage point headwind from increased work-in-progress.
Fetal Focus Launch Success
The Fetal Focus product launch is exceeding expectations, approaching an annualized run rate of 200,000 orders. This growth is supported by the EXPAND trial data, which was selected for an oral plenary presentation at the Society of Maternal Fetal Medicine Meeting and has been submitted for peer-reviewed publication. The majority of these orders are not included in core test processed numbers, indicating even stronger underlying women's health growth.
Oncology Growth Drivers
Clinical MRD volume reached nearly 250,000 tests, now on a run rate of over 1 million annually. Growth was driven by new data readouts and publications in various cancer types (bladder, colorectal, breast, uterine, lymphoma), integration with Onco EMR across 4,500 physicians, expanded commercial footprint, and the acquisition of Foresight Diagnostics.
Signatera ASP and Reimbursement Progress
Average Selling Prices (ASPs) for Signatera reached approximately $1,250, up $25 from Q4, driven by better alignment with Medicare Advantage plans and consistent reimbursement for biomarker services. The company aims for a long-term Signatera ASP target of $2,000 per test, which at current volumes, could generate an additional $750 million in revenue and gross profit annually. Efforts continue to secure Medicare coverage for additional histologies.
Treatment on MRD (TOMR) Paradigm
New data highlights Signatera's utility in enabling surgery avoidance in bladder, rectal, and breast cancers for MRD-negative patients, improving quality of life and reducing overtreatment. The ALPHA3 trial in large B-cell lymphoma demonstrated a 41-point absolute delta in MRD clearance for the treatment arm, showcasing the potential for earlier, more aggressive interventions or deferred treatments based on MRD status.
Early Cancer Detection (ECD) Progress
The FIND CRC study, an FDA-enabling colorectal cancer screening trial, is ahead of schedule, with enrollment for PMA submission expected to complete in Q3 2026, targeting an FDA PMA readout in 2027. This study builds on previous data showing 22.5% sensitivity for advanced adenomas at 91.5% specificity, aiming to prevent cancer by detecting precancerous lesions.
Japan Launch for Signatera
PMDA approval for Signatera in Japan is on track for Q2 2026, with commercial launch preparations advancing. Japan represents a significant growth opportunity, with a similar number of CRC diagnoses as the US, potentially doubling Signatera's annual CRC volume TAM. Favorable clinical guidelines and a single national payer system are expected to support rapid adoption.