Company: BLLN
Filing Date: 2025-06-20
Form Type: DRS
Source: 0000950123-25-006095
Chunk: 173

Company: BillionToOne, Inc.
Filing Date: 2025-06-20
Form: DRS
Chunk 173
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 RhoGAM) at 28 weeks’ gestation and postpartum. However,
this approach lacks precision, as 40% of RhD-negative pregnancies 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 y and 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. Since launching, UNITY Fetal RhD NIPT has been ordered for over 150,000 patients, with data published in peer-reviewed studies demonstrating 100% concordance with neonatal outcomes and sensitivity/specificity of >99.9%.

UNITY Fetal Antigen NIPT

Alloimmunization
occurs when a pregnant individual’s immune system produces antibodies against fetal red blood cell (RBC) antigens. This can happen when a RhD negative pregnant mother carrying an RhD positive fetus does not receive RhIG. This can also happen
with other rare RBC antigens are present, such as Kell, especially due to a blood transfusion prior to the pregnancy. This can lead to HDFN, a condition that can cause

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severe anemia, hydrops fetalis, or fetal demise. Managing these pregnancies is challenging. The current methods to determine fetal antigen status, such as amniocentesis, are often invasive. These
invasive procedures could cause maternal and fetal blood to mix, which would exacerbate HDFN. As a result, many patients experience undue anxiety, unnecessary and expensive weekly monitoring, frequent antibody titer checks, and intensive
surveillance. In approximately 65% of these pregnancies, the fetus is negative for the antigen and therefore there is no fetal risk.

To address this issue, we
launched UNITY Fetal Antigen NIPT in 2022