Enrollment Tops 1,600 in Natera's EXPAND Trial of Single Gene NIPT
EXPAND is a prospective, blinded, multi-site clinical trial with diagnostic outcomes on all subjects
Natera, Inc. (NASDAQ:NTRA), a global leader in cell-free DNA (cfDNA) testing and precision medicine, today announced a milestone in the EXPAND trial with the enrollment of over 1,600 patients.
Initiated in 2023, EXPAND is designed to be the defining prospective clinical trial in the category, supporting Natera's Fetal Focus™ single gene noninvasive prenatal test (NIPT) for inherited conditions. The study is differentiated by having all outcomes, including both positive and negative results, confirmed by genetic truth using prenatal or postnatal diagnostic testing1, 2. EXPAND has enrolled a diverse, multi-ethnic population from leading academic medical centers and maternal fetal medicine clinics.
Natera expects to report a large-scale analysis from the trial in the fourth quarter of 2025. This follows the successful initial readout of EXPAND earlier this year, in which Fetal Focus demonstrated 91% sensitivity and successfully identified 5/5 fetuses affected by challenging homozygous variants.
Fetal Focus addresses a clear unmet need when the biological father is unavailable or unable to complete carrier testing. While testing both partners remains the guideline-recommended gold standard3,4 and the optimal approach to screen for affected pregnancies, if carrier testing of the biological father is not possible, Fetal Focus is a clinically useful alternative.
"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. "Our proprietary LinkedSNP™ technology improves detection of inherited conditions, giving families and clinicians additional insights during pregnancy."
References
- Internal data on file. In EXPAND, the study participants and investigators are blinded to the Fetal Focus™ test results.
- EXpanding Prenatal Cell Free DNA Screening Across MoNogenic Disorders (EXPAND). https://clinicaltrials.gov/study/NCT06808880. Accessed July 2025.
- Gregg et al., Genetics in Medicine volume 23, pages 1793–1806 (2021).
- ACOG Practice Committee Opinion, 691 (2017; reaffirmed in 2025).
About Natera
Natera™ is a global leader in cell-free DNA and genetic testing, dedicated to oncology, women's health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard-of-care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera's tests are supported by more than 300 peer-reviewed publications that demonstrate excellent performance. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California. For more information, visit www.natera.com.
Forward-Looking Statements
All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera's plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera's expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy and performance of our tests, or of the benefits of our tests and product offerings to patients, providers and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera's recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.
View source version on businesswire.com: https://www.businesswire.com/news/home/20251001833625/en/
Investor Relations: Mike Brophy, CFO, Natera, Inc., [email protected]
Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., [email protected]