Company: BLLN
Filing Date: 2025-09-17
Form Type: DRS/A
Source: 0001193125-25-206347
Chunk: 212

Company: BillionToOne, Inc.
Filing Date: 2025-09-17
Form: DRS/A
Chunk 212
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 100% positive predictive value for this specific high-risk group. The researchers concluded that carrier testing followed by reflex sgNIPT is highly accurate for 
 general population screening and, is a viable option for most pregnant individuals.                                                                                                                                                                       |

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In addition to robust performance above 99.7% sensitivity and 99.9% specificity for common trisomies, UNITY Aneuploidy NIPT uniquely leverages smNGS technology to enhance 22q11.2 Microdeletion Analysis, addressing a critical gap in competing prenatal screening tests. 56As the most common microdeletion disorder, 22q11.2 deletion syndrome (DiGeorge Syndrome) has historically resulted in low positive predictive values (PPV), reducing clinical confidence and resulting in patient anxiety. smNGS enables >95% sensitivity and >99.9% specificity, which results in an industry-leading PPV of 80% in average risk pregnancies. 57More than 70% of UNITY Aneuploidy orders now include 22q11.2 optional add-ontesting. UNITY Fetal RhD NIPT Approximately 15% of pregnant individuals in the United States are RhD-negative,putting them at risk of RhD alloimmunization if they are carrying an RhD-positivefetus. To prevent this, the standard of care has been the administration of Rho(D) immune globulin (RhIG) (e.g., RhoGAM) at 28 weeks’ gestation and postpartum. However, this approach lacks precision, as 40% of RhD-negativepregnancies do not require RhIG because the fetus is also RhD-negative.Administering RhIG to these pregnancies is unnecessary, costly, and limits supply availability for those who need it most. This is because RhIG availability can be limited given it is a blood product derived from human donors. To address this issue, we launched UNITY Fetal RhD NIPT in 2020 to detect fetal D antigen. While other tests for fetal RhD detection were launched in 2024, UNITY Fetal RhD NIPT remains the only test that can accurately detect fetal RhD status when the pregnant individual has RhD yand RhD-CE-Dhybrid genes, which are prevalent in Black (45%) and Asian (>10%) populations. Other fetal RhD NIPTs are limited in their ability to detect these genetic complexities. UNITY Fetal RhD NIPT addresses these limitations through our revolutionary smNGS platform