EXPAND Trial of Natera’s Fetal Focus™ Single-Gene NIPT Surpasses >2,000 Patients Enrolled

Key Terms

cell-free dna medical

Fragments of DNA that float freely in the bloodstream after being released by dying or damaged cells, like puzzle pieces carried downstream that hint at what’s happening upstream. Investors care because measuring these fragments enables non‑invasive tests — for example to detect cancer, monitor treatment response, check pregnancy health, or spot organ rejection — so advances, approvals, or reimbursement changes can quickly affect companies that develop the tests and related technologies.

noninvasive prenatal test medical

A noninvasive prenatal test is a screening blood test given to a pregnant person that analyzes tiny fragments of the fetus’s genetic material circulating in the mother’s bloodstream to assess the risk of certain genetic conditions. For investors, it matters because test accuracy, regulatory approval, reimbursement, and adoption determine market size, revenue growth and competitive dynamics in the prenatal diagnostics industry—similar to how a faster, cheaper gadget can reshape consumer demand.

nipt medical

Non-invasive prenatal testing (NIPT) is a blood test that screens for certain genetic conditions in a fetus by examining small fragments of the baby’s DNA present in the pregnant person’s blood, avoiding invasive procedures that enter the womb. It matters to investors because test uptake, accuracy, regulatory approval, and pricing determine revenue and margins for companies offering the technology—think of NIPT as a safer, earlier health check (like a smoke alarm for genetic risk) that can drive demand and competitive dynamics in healthcare markets.

homozygous medical

Homozygous describes when a person or organism carries two identical copies of a particular gene version, one from each parent. For investors, this matters in biotech and healthcare because being homozygous can strongly influence how a patient responds to a drug, the accuracy of a genetic test, or the market size for a treatment—think of it like having two identical keys that either both fit a lock or both fail, which changes product effectiveness and commercial outcomes.

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Milestone follows prestigious oral plenary presentation of EXPAND data at SMFM Annual Meeting

AUSTIN, Texas--(BUSINESS WIRE)-- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA (cfDNA) testing and precision medicine, today announced that the EXPAND clinical trial has enrolled over 2,000 patients, more than doubling enrollment in the last 12 months.

EXPAND is a prospective, blinded, multi-site clinical trial designed to study Natera’s Fetal Focus single-gene noninvasive prenatal test (NIPT). The trial was featured in an oral plenary session at the Society for Maternal-Fetal Medicine (SMFM) Annual Meeting in February 2026. The presentation highlighted strong clinical performance in the first milestone readout of EXPAND, as well as the study’s rigorous design, including confirmation of all outcomes against genetic truth.

Fetal Focus provides fetal risk assessment for 21 genes associated with serious, early-onset medical conditions. The test is an option for pregnant patients who test positive with Natera’s Horizon™ carrier screen when the father is unavailable for guideline-recommended carrier testing.¹

It incorporates Natera’s proprietary ultra-sensitive LinkedSNP™ technology to determine whether a fetus has inherited disease-causing variants from one or both parents. In difficult homozygous cases, where the child inherits the same variant from both parents, Natera’s technology has performed well, identifying 5 out of 5 such cases.^2-3

“In developing Fetal Focus, our goal has been to expand the scope of what noninvasive prenatal testing can deliver,” said Sheetal Parmar, SVP of Medical Affairs, Women’s Health at Natera. “With more than 2,000 patients enrolled, EXPAND is helping to set a new standard for clinical evidence in single-gene NIPT, and we remain focused on generating high-quality data to support clinicians and the families they serve.”

References

1. ACOG Committee Opinion #690, Mar 2017.
2. Internal data on file. In EXPAND, the study participants and investigators are blinded to the Fetal Focus™ test results.
3. EXpanding Prenatal Cell Free DNA Screening Across MoNogenic Disorders (EXPAND). https://clinicaltrials.gov/study/NCT06808880. Accessed May 2026.

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 400 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, and through Foresight Diagnostics, its subsidiary, operates an ISO 27001-certified and CAP-accredited laboratory certified under CLIA in Boulder, Colorado. 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 our efforts to develop and commercialize new product offerings, 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/20260520113179/en/

Investor Relations: Mike Brophy, CFO, Natera, Inc., investor@natera.com
Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., pr@natera.com

Source: Natera, Inc.