Natera Announces Expansion to 20 Genes for its Fetal Focus™ Single-Gene NIPT

AUSTIN, Texas--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA (cfDNA) and precision medicine, today announced it will expand its Fetal Focus test to cover 20 genes, marking a major advancement in single-gene noninvasive prenatal testing (sgNIPT). Building on the success of the initial Fetal Focus 5-gene test, launched in August, the new expanded panel will launch in Q4 2025.

Fetal Focus’ unique approach, using Natera’s proprietary LinkedSNP™ technology, is optimized to detect challenging homozygous cases where the fetus inherits two copies of the same mutation from both parents. Since the product launch, Fetal Focus has already identified a pregnancy affected with cystic fibrosis that was homozygous for the delta F508 mutation and missed by another laboratory. While this case highlights the utility of Natera’s LinkedSNP technology, clinical performance of genetic tests should be rigorously established in prospective, well-designed clinical studies.

Initiated in 2023, EXPAND is designed to be the defining prospective clinical trial in the category, supporting Natera’s Fetal Focus sgNIPT 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 testing. Testing all negatives in particular is critical for a robust estimate of test sensitivity. EXPAND has enrolled approximately 1,700 patients representing a diverse, multi-ethnic population from leading academic medical centers and maternal fetal medicine clinics.

“Homozygous cases are challenging to detect, and the initial readout from the EXPAND trial showed that Fetal Focus successfully identified 5 out of 5 such cases,” said Ramesh Hariharan, general manager, women’s health at Natera.

Fetal Focus enables prenatal detection of severe, early onset inherited conditions, through a simple blood draw from the mother. The test analyzes fetal cfDNA in maternal blood to determine whether a fetus has inherited disease-causing mutations from one or both parents.

About Natera

Natera™ is a global leader in cell-free DNA and precision medicine, 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 325 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.