Natera's Signatera Becomes First Approved MRD Test for Colorectal Cancer in Japan
核心洞察
Natera's Signatera (搜索) test received regulatory approval in Japan, becoming the first molecular residual disease (MRD) test approved for patients with colorectal cancer (搜索) in the country.
Signatera (搜索) is expected to launch in Japan by the end of 2026, expanding Natera's oncology testing footprint into a new major market.
Natera processed over 800,000 oncology tests in 2025, a 51.6% increase from 2024, reflecting strong demand for blood-based cancer recurrence detection.
Natera's Signatera (搜索) test has become the first molecular residual disease (MRD) test approved for patients with colorectal cancer (搜索) in Japan, marking a significant regulatory milestone for the diagnostics company and its blood-based cancer testing platform. The approval, announced in June, positions Signatera for a commercial launch in Japan by the end of 2026.
The Japanese approval represents an expansion of Natera's oncology testing reach into a new major market. Signatera (搜索), a cell-free DNA-based test designed to detect cancer recurrence, holds a dominant share of the minimal residual disease (MRD) testing market, a segment characterized by strong demand for products that help detect cancer recurrence.
Natera specializes in cell-free DNA testing and offers testing across oncology, organ health, and women's health, as well as testing for rare diseases. Oncology testing has been a particular source of growth for the company. In 2025, Natera increased its processed oncology tests by 51.6%, from over 528,000 in 2024 to more than 800,000 in 2025. In the first quarter of 2026, the company also saw a more than 50% increase in processed oncology tests.
The company's broader testing volumes have continued to climb. Natera processed 3.5 million total tests in 2025, a 15% increase from 2024. In the first quarter of 2026, it exceeded one million processed tests in a quarter for the first time.
Alongside the Japanese approval, Natera is now seeking regulatory approval for Signatera (搜索)'s use as a test for muscle-invasive bladder cancer (搜索), reflecting ongoing efforts to expand the product's label into additional indications.
The regulatory progress comes amid strong financial performance. In 2025, Natera generated $2.3 billion in revenue, a 35.9% increase from 2024. In the first quarter of 2026, the company reported revenue of $697 million, a 39% increase, and boosted the midpoint of its full-year sales guidance by $120 million. In the second quarter of 2026, revenue increased 37.7% year over year, from $546.6 million to $752.8 million, alongside a more than 100-basis-point improvement in gross margins and further progress toward profitability. Management raised full-year revenue guidance from $2.85 billion to $2.91 billion.
Despite this momentum, Natera remains unprofitable. The company reported a net loss of $208.2 million in 2025, up from a net loss of $190.4 million in 2024, and continues to invest heavily in research and development, with R&D costs climbing from $129.1 million in Q1 2025 to $210.7 million in Q1 2026.
The market opportunity underlying Natera's growth is substantial. According to Grand View Research, the global genetic testing market was valued at $11.7 billion in 2024 and is expected to reach $39.3 billion by 2030. The global cancer diagnostics market is even larger, expected to climb from $119.8 billion in 2025 to $191.1 billion by 2033.
Natera's stock has reflected investor enthusiasm for these developments. Shares have rallied over 37% year to date, compared with a 13.9% gain for the S&P 500 over the same period. Over the last 12 months, the Natera stock price has risen more than 72%. Analysts generally view the company favorably, with 19 out of 22 rating Natera a buy.