Molecular diagnostics company BillionToOne on Friday announced the launch of its Unity fetal antigen single-gene noninvasive prenatal test (sgNIPT) as an addition to its Unity Screen line of NIPT testing products.
The NIPT test looks for the presence of the genetic variants that code for fetal antigens corresponding to C, c, D, E, Duffy (Fya), or Kell (K) red blood cell (RBC) antibodies in alloimmunized pregnant patients, BillionToOne said.
The test generates a report to show whether the fetal antigen of interest is detected, enabling stronger clinical conviction for patients who require monitoring, the company added.
BillionToOne said that the Unity NIPT may streamline management for pregnancies thought to be at risk for hemolytic disease of the fetus and newborn (HDFN), a rare but potentially deadly condition.
Analytical validation data show that the test's sensitivity and specificity are greater then 99.9%, the firm said, adding that a manuscript with the validation information is being submitted for peer review and is expected to be available before the end of the year.
The fetal antigen NIPT is available to patients at 10 weeks or more gestation, the company said.