Natera enrolls over 1,600 patients in EXPAND trial for fetal testing

Published 01/10/2025, 13:06
Natera enrolls over 1,600 patients in EXPAND trial for fetal testing

AUSTIN - Natera, Inc. (NASDAQ:NTRA), a $22 billion diagnostics company showing impressive 44% year-over-year revenue growth, has enrolled more than 1,600 patients in its EXPAND clinical trial, the company announced Wednesday. According to InvestingPro analysis, the company currently appears fairly valued based on its Fair Value assessment. The prospective, blinded, multi-site study is evaluating Natera’s Fetal Focus single gene noninvasive prenatal test for inherited conditions.

Initiated in 2023, the EXPAND trial is designed to confirm both positive and negative test results through prenatal or postnatal diagnostic testing. The study has recruited a diverse, multi-ethnic population from academic medical centers and maternal fetal medicine clinics.

Natera expects to report comprehensive analysis from the trial in the fourth quarter of 2025. An initial readout earlier this year showed the Fetal Focus test demonstrated 91% sensitivity and successfully identified five fetuses affected by homozygous variants.

The company’s test addresses situations where the biological father is unavailable for carrier testing. While testing both parents remains the recommended approach according to clinical guidelines, Fetal Focus offers an alternative when paternal testing isn’t possible.

"Fetal Focus is addressing an important clinical need for patients and has shown excellent performance in the initial readout of the EXPAND trial," said Sheetal Parmar, senior vice president of medical affairs, women’s health at Natera, according to the press release.

The information in this article is based on a company press release statement. InvestingPro data reveals 11 analysts have recently revised their earnings expectations upward for Natera, with additional insights available in the comprehensive Pro Research Report, part of the premium subscription covering 1,400+ US stocks.

In other recent news, Natera, Inc. announced significant findings from a study involving its Signatera test for testicular cancer, demonstrating superior performance compared to standard tumor markers in predicting patient outcomes. This study, published in the Journal of Clinical Oncology - Precision Oncology, involved 324 plasma samples from 74 patients across various stages of the disease. Additionally, the Signatera test showed promising results in monitoring recurrence and treatment response in early-stage uterine cancer, as published in the same journal. In the investment sector, Wells Fargo resumed coverage of Natera with an Equal Weight rating, highlighting the company’s strong position in the cell-free DNA testing market. Meanwhile, Piper Sandler reiterated an Overweight rating, pointing to positive outcomes from Natera’s IMvigor011 trial, which demonstrated a correlation between MRD-negative status and improved overall survival. However, Natera faced a legal setback when a North Carolina district court invalidated its patent claims in a dispute with NeoGenomics, resulting in a ruling against Natera’s asserted patents. These developments highlight a mix of advancements and challenges for Natera in recent times.

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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