Natera announced the expansion of its Fetal Focus single‑gene non‑invasive prenatal test (sgNIPT) to 21 genes, adding 16 new conditions—including Tay‑Sachs, Gaucher, and galactosemia—to the panel that originally launched in 2023.
The blinded prospective EXPAND trial, enrolling more than 1,800 participants, reported 96% sensitivity and 98% population‑weighted specificity across all 21 genes. In the latest cohort of 193 samples, the test achieved 100% sensitivity for 14 affected pregnancies and 94.2% observed specificity.
The expansion leverages Natera’s proprietary LinkedSNP technology, which improves detection of homozygous cases and enhances overall accuracy. The trial results reinforce the company’s position as a leader in single‑gene non‑invasive prenatal testing.
The launch follows strong financial performance in 2024, with Q4 revenue of $476.1 million, up 53% YoY, and full‑year revenue of $1.696 billion, up 56.7% YoY. Gross margin rose to 62.9% from 51.4% in Q4 2023, driven by a higher mix of high‑margin tests and scale.
CEO Steve Chapman highlighted the company’s momentum, noting that the expanded panel “provides a more comprehensive screening option for expectant parents, especially when partner testing is unavailable.” He also emphasized confidence in continued growth, citing the raised 2025 revenue guidance of $1.87 billion to $1.95 billion.
Analysts have responded positively, with a consensus “Strong Buy” rating and price targets ranging from $206 to $285. The trial’s high sensitivity and specificity are expected to support market adoption and strengthen Natera’s competitive edge against rivals such as Illumina and Ariosa.
The expanded panel is expected to broaden Natera’s market share in the NIPT space, potentially driving additional revenue streams and reinforcing the company’s strategy to expand its women’s health portfolio.
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