Company: BLLN
Filing Date: 2025-09-17
Form Type: DRS/A
Source: 0001193125-25-206347
Chunk: 226

Company: BillionToOne, Inc.
Filing Date: 2025-09-17
Form: DRS/A
Chunk 226
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ous inheritance of delta F508, leading the patient to opt for amniocentesis and a prenatal diagnostic confirmation of CF. Subsequently, the mother
received TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor) treatment during pregnancy, and the baby was able to receive further treatment at just two weeks old.

This case demonstrates how UNITY Fetal Risk Screen’s personalized fetal risk assessment enabled timely intervention and specialist referrals that may not have been
possible with traditional carrier screening, which often has delays and lower partner participation rates.

Study 2: In a similar case, a patient who presented with
echogenic bowel on ultrasound was identified as a CF carrier with sgNIPT showing a 9 in 10 chance of the baby being affected with CF. The amniocentesis confirmed the diagnosis. After referral to a pulmonologist, the patient received TRIKAFTA during
pregnancy, starting at 27 weeks of gestation. Despite earlier ultrasound findings, the baby was able to be discharged without a neonatal intensive care unit stay and passed newborn screening (NBS) for CF. It is extremely rare for a newborn with CF
to pass NBS. Given the echogenic bowel on ultrasound during pregnancy, early diagnosis by UNITY and subsequent treatment enabled this newborn to have a significantly better outcome and avoid a potentially lengthy NICU stay.

UNITY Fetal Antigen NIPT patient case study: Assessing big C alloimmunization risk for streamlined care

During routine prenatal lab work, a pregnant patient was found to be alloimmunized to the big C antigen. The patient’s
OB-GYN ordered UNITY Fetal Antigen NIPT at 14 weeks gestation to assess the fetal antigen status of the pregnancy. UNITY Fetal Antigen NIPT revealed a “not detected” result, indicating that the
baby did not express the big C antigen and the pregnancy was not at risk for HDFN. As a result, the patient avoided the need for weekly intensive monitoring by a specialist, invasive procedures, and regular blood draws, significantly reducing
healthcare costs and her anxiety. This early identification through the UNITY Fetal Antigen NIPT provided critical information that guided the management of her pregnancy, ensuring it progressed without

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complications related to alloimmunization. This case highlights the value of UNITY Fetal Antigen NIPT in streamlining prenatal care, minimizing unnecessary interventions and risks, and removing
the fear of the unknown for the patient