Company: BLLN
Filing Date: 2025-06-20
Form Type: DRS
Source: 0000950123-25-006095
Chunk: 172

Company: BillionToOne, Inc.
Filing Date: 2025-06-20
Form: DRS
Chunk 172
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 <1 in 10,000 
 to 9 in 10, providing clear, actionable information for clinicians and patients; and                                    |

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| • |     | Whether the risk is classified as low or high risk |

UNITY Fetal Risk Screen’s accuracy has been validated in multiple peer-reviewed studies. A 2023 study published in Prenatal Diagnosisdemonstrated 100% of “9 in 10” risk pregnancies were confirmed to be affected pregnancies. Because UNITY Fetal Risk Screen does not rely on paternal testing, which is often not completed, it detects up to three times as many affected pregnancies for these recessive conditions compared to traditional carrier screening. UNITY Aneuploidy Screen In 2020, we launched our UNITY Aneuploidy Screen, which we believe has become the most performant assay for aneuploidies. Compared to many competing tests, our test overcomes the significant challenge of low fetal cfDNA levels in the mother’s blood, which often produces inconclusive results. This issue can be particularly pronounced for single nucleotide polymorphism-based NIPTs, which tend to have a higher fetal fraction cutoff 134

to provide conclusive results. Our smNGS platform provides a critical signal boost that is especially noticeable at lower fetal fractions, significantly reducing inconclusive results.

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. As 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. More than 70% of UNITY Aneuploidy
orders now include 22q11.2 optional add-on testing.

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-positive fetus. To prevent this, the standard of care has been the administration of Rho(D) immune globulin (RhIG) (e.g.,