Natera launches Fetal Focus test for inherited conditions

Published 07/08/2025, 12:14
Natera launches Fetal Focus test for inherited conditions

AUSTIN - Natera, Inc. (NASDAQ:NTRA), a healthcare diagnostics company with a market capitalization of $18.86 billion and impressive revenue growth of 51.5% in the last twelve months, announced on Thursday the launch of Fetal Focus, a noninvasive prenatal test designed to screen for inherited conditions when a biological father is unavailable for testing. According to InvestingPro analysis, the stock is currently trading above its Fair Value, reflecting strong investor confidence in the company’s innovative capabilities.

The new test addresses a gap in prenatal care by allowing direct screening of the fetus through a sample of the mother’s blood when she tests positive as a carrier for certain genetic conditions. Fetal Focus is validated for analyzing five genes associated with cystic fibrosis, spinal muscular atrophy, alpha-thalassemia, and beta-hemoglobinopathies including sickle cell disease. The company maintains a healthy financial position with a strong current ratio of 3.87, indicating robust operational capabilities to support its innovative product launches.

The launch is supported by initial data from EXPAND, a large prospective clinical trial that has enrolled approximately 1,300 participants. In its first milestone readout involving 101 cases, the test demonstrated 91% sensitivity and identified all five fetuses affected by homozygous variants, according to the company’s statement.

"Having access to a noninvasive option like Fetal Focus can provide critical information to support decision-making during pregnancy, especially in situations where partner testing isn’t possible," said John Williams, M.D., chief principal investigator for EXPAND and director of reproductive genetics at Cedars-Sinai.

The test utilizes Natera’s proprietary LinkedSNP technology, which the company says improves detection across diverse populations. Medical guidelines typically recommend partner testing when a pregnant patient is identified as a carrier of a recessive single-gene condition to determine the risk for the baby.

Natera stated that the EXPAND study, initiated in 2023, includes participants from various ethnic backgrounds and confirms both positive and negative results through diagnostic testing.

The company’s announcement was based on a press release statement issued Thursday. With a gross profit margin of 61.79% and substantial market presence, Natera continues to demonstrate strong execution in the healthcare diagnostics sector. For deeper insights into Natera’s financial health and growth prospects, including 8 additional ProTips and comprehensive analysis, visit InvestingPro.

In other recent news, Natera has reported several significant developments. The company showcased strong first-quarter performance in 2025, leading RBC Capital Markets to maintain an Outperform rating with a $251 price target, citing effective commercial execution and revenue growth. Natera’s earnings have been bolstered by expanded Medicare coverage for its Signatera MRD assay, now including a wider range of cancers, which was announced after a pan-cancer study presentation at the 2025 ASCO Annual Meeting. Additionally, TD Cowen raised its price target for Natera to $200, highlighting a 13% sales increase, driven by a 5% rise in core sales and other favorable factors.

The company also announced that MolDX granted Medicare coverage for its WGS Signatera assay, following a successful bridging study, which may lead to similar reimbursement as the WES Signatera. Analysts at Leerink Partners reiterated an Outperform rating with a $220 price target, emphasizing the importance of this Medicare decision. Evercore ISI initiated coverage with an Outperform rating and a $170 price target, suggesting a potential upside. Natera’s Signatera product saw a 52% year-over-year increase in clinical volumes for the first quarter, reaching approximately 17,000, surpassing expectations and mitigating concerns about weather-related disruptions.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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