Natera Launches Fetal RhD NIPT Supporting Ob/Gyn Physicians and Patients During RhIg Shortage

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA (cfDNA) and genetic testing, today announced the launch of a new cfDNA-based fetal RhD test. This comes at a critical time for the healthcare industry, helping physicians navigate patient care given nationwide shortages of Rho(D) immune globulin therapy (RhIg).

Natera’s test can be performed as early as nine weeks gestation and determines fetal RhD status from the blood of a pregnant patient, including complex pseudogene and RhD-CE-D hybrid variants. The vast majority of other NIPT laboratories do not offer fetal RhD assessment, which makes it a key differentiator in addition to Natera’s core SNP-based technology.

Up to 15 percent of pregnant patients are RhD-negative¹. When the maternal blood type is RhD-negative and the fetal blood type is RhD-positive, antibodies can develop (alloimmunization) that can lead to hemolytic disease of the fetus and newborn. Historically, this risk is well managed by giving RhIg to all RhD-negative patients despite the fact that only 60%² of them carry an RhD-positive fetus. In response to the nationwide shortage of RhIg, the American College of Obstetricians and Gynecologists (ACOG) recently stated that using NIPT to “prioritize use of RhIg and conserve RhIg supply is a reasonable consideration.”

The product launch is backed by a validation study that included fetal RhD status confirmed via newborn serology in more than 650 RhD-negative pregnancies. This is roughly 10 times more patients with confirmed outcomes than validation studies from other laboratories. Natera’s test performed with 100% sensitivity and greater than 99% specificity.

Natera’s study was accepted as a late-breaking abstract for ACOG’s Annual Clinical & Scientific Meeting, and the results will be presented at the meeting on May 18, 2024. This clinical validation is Natera’s second study on fetal RhD. In 2023, Natera presented data at the American Society of Human Genetics (ASHG) Annual Meeting on 180 RhD-negative pregnancies, which showed similar performance.

“Having an accurate, well-validated fetal RhD test is critical given the current shortage of RhIg and the tremendous complications alloimmunization can cause to a baby’s health in a subsequent pregnancy,” said Victor Klein, M.D., M.B.A., System Director of Quality & Patient Safety for Obstetrics & Gynecology at Northwell Health. “It is especially important that clinicians have access to these tools right now to help determine which patients are most in need of RhIg.”