Natera Announces That Its EXPAND Clinical Trial Has Enrolled Over 2,000 Patients, More Than Doubling Enrollment In The Last 12 Months

Natera

Natera

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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."