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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.
Posted In: NTRA
