Company: BLLN
Filing Date: 2025-08-11
Form Type: DRS/A
Source: 0000950123-25-007483
Chunk: 197

Company: BillionToOne, Inc.
Filing Date: 2025-08-11
Form: DRS/A
Chunk 197
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 lead to HDFN, a condition that can cause 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. 54 To address this issue, we launched UNITY Fetal Antigen NIPT in 2022. Our UNITY Fetal Antigen NIPT addresses a critical gap in managing alloimmunized pregnancies and detects key fetal RBC antigens, including D, C, c, E, K (Kell), and Fya (Duffy), helping to guide clinical decisions and reduce unnecessary monitoring. As the only commercially available test for fetal antigen screening in the United States, UNITY Fetal Antigen NIPT not only solves a previously unmet clinical need but has deepened our relationships with Maternal-Fetal Medicine (MFM) specialists. Current Clinical Recommendation WEEK 10 Partner sample collected to determine antigen status. (assuming partner is available) WEEK 12 If partner is antigen positive, invasive diagnostic testing offered but frequently declined. WEEKS 12-13 Titers are monitored frequently via maternal blood draw. Regular middle cerebral arterial Doppler assessment may be recommended. WEEK 37 Baby likely to be delivered early. UNITY Fetal Antigen NIPT WEEK 9 Fetal Antigen NIPT ordered WEEK 10 Fetal antigen status provided as "detected" or "not detected" to guide pregnancy management. up to 65% of pregnancies are not at risk UNITY Fetal Antigen NIPT’s clinical accuracy has been validated in multiple peer-reviewed publications, including a Scientific Reports study demonstrating 100% concordance between test results and neonatal antigen status. UNITY Fetal Antigen NIPT offers 100% sensitivity and specificity while maintaining a no-callrate of <0.1%, ensuring highly reliable results. In 2024, ACOG issued two clinical guideline updates, referencing UNITY Fetal RhD NIPT and UNITY Fetal Antigen NIPT data: (i) acknowledging the role of fetal RhD NIPT in triaging anti-Dimmunoglobulin (e.g., RhoGAM) use, particularly amid shortages,