Natera's fetal genetic testing trial enrolls over 2,000 patients

Natera Inc. (NASDAQ: NTRA) announced that its EXPAND clinical trial has enrolled more than 2,000 patients, representing a doubling of enrollment over the past 12 months.

The EXPAND trial is testing Natera's Fetal Focus single-gene noninvasive prenatal test, which assesses fetal risk for 21 genes associated with serious, early-onset medical conditions. The prospective, blinded, multi-site clinical trial was presented at the Society for Maternal-Fetal Medicine Annual Meeting in February.

Fetal Focus is designed for pregnant patients who test positive with Natera's Horizon carrier screen when the father is unavailable for carrier testing. The test uses Natera's LinkedSNP technology to determine whether a fetus has inherited disease-causing variants from one or both parents.

According to company data, the technology identified 5 out of 5 cases where a child inherited the same variant from both parents, which the company describes as difficult homozygous cases.

"With more than 2,000 patients enrolled, EXPAND is helping to set a new standard for clinical evidence in single-gene NIPT," said Sheetal Parmar, senior vice president of medical affairs for women's health at Natera.

The trial confirmation includes verification of all outcomes against genetic truth, according to the company's press release statement.

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