Company: BLLN
Filing Date: 2025-09-17
Form Type: DRS/A
Source: 0001193125-25-206347
Chunk: 215

Company: BillionToOne, Inc.
Filing Date: 2025-09-17
Form: DRS/A
Chunk 215
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etal RhD NIPT and UNITY Fetal Antigen NIPT but also further highlighted their critical role in enhancing patient care and ensuring effective management of patients across diverse populations. UNITY Fetal Antigen CTA NIPT In December 2023, we announced a global partnership with Johnson & Johnson to provide our UNITY Fetal Antigen clinical trial assay (CTA) in their AZALEA Phase 3 clinical trial of nipocalimab in pregnancies at risk for severe HDFN. In April 2023, the FDA granted an Investigational Device Exemption (IDE) for the assay’s use in

| 59 |     | Wynn, J., Hoskovec, J., Carter, R., et al. (2023). “Performance of single-gene noninvasive prenatal testing for autosomal recessive conditions in a general population setting.” Prenatal Diagnosis, 
 43(10), 1344-1354.                                                                                                                                                                                   |

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the trial. Final FDA approval of the companion diagnostics indication is dependent on the success of the Johnson & Johnson AZALEA Phase 3 clinical trial. We have also received regulatory clearances from health authorities in certain European and Latin American countries for the use of the assay in a global clinical trial. We believe that a successful completion of this Phase 3 trial may enable our test to be the first NIPT that is granted a companion diagnostics indication. Our comprehensive customer experience and commitment to quality and innovation beyond our tests UNITY Complete is more than just a test, it is a fully integrated, end-to-endexperience that delivers a seamless workflow for both patients and providers. Over the years, we have developed various software tools to support the entire testing workflow for providers and patients, which has fueled the rapid growth of the UNITY Complete portfolio. We continuously refine our workflow to address the evolving needs of obstetric providers, in an effort to maximize efficiency, accessibility, and ease of adoption for both patients and providers. By combining unique clinical testing with workflow enhancements, we believe UNITY Complete has established a highly scalable infrastructure that streamlines every step of the journey, further solidifying that UNITY Complete is becoming the new standard in prenatal care. Oncology products Precision oncology continues to be a focus in the global fight to cure cancer. However, despite significant advancements and growth in the field, cancer continues to rank as the second leading cause of death worldwide, with persistently high mortality rates. 60Liquid biopsies, or blood-based tests that interrogate ctDNA, cfDNA released from a tumor