Company: BLLN
Filing Date: 2025-06-20
Form Type: DRS
Source: 0000950123-25-006095
Chunk: 166

Company: BillionToOne, Inc.
Filing Date: 2025-06-20
Form: DRS
Chunk 166
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rosis or sickle-cell disease could only be detected by invasive methods such as amniocentesis following carrier testing of the parents. By first focusing our smNGS platform on directly
assessing fetal risk for these conditions, we expanded the indication of NIPT from more than one million base pair aneuploidies to single base pair conditions. Currently, we are the second largest prenatal genetics laboratory in the United States by
revenue, achieving a % revenue growth rate to $ million in the 12-month period ended June 30, 2025 from the preceding 12-month period.
We estimate the market opportunity for our prenatal products to be over $2.5 billion annually in the United States.

Building on our success in the prenatal
market, we have applied our smNGS platform to solve similar technical challenges in the oncology market – specifically focusing on late-stage cancer. In 2023, we launched offerings in oncology specifically related to therapy selection
(Northstar Select) and response monitoring (Northstar Response). We estimate the annual market opportunity for these two products to be more than $20 billion, and critically, we estimate that the market is less than 20% penetrated today by all
molecular diagnostics companies. We also plan to expand our product portfolio and are developing a tissue-free, pan-cancer MRD test, which we expect to be commercially available in 2026. We estimate the annual
United States market opportunity for MRD to be over $30 billion. Longer term, we believe that our smNGS-based technology could address the sensitivity challenges of early-stage cancer detection; however, we have not yet started development in this
area. We estimate the annual United States market opportunity for early detection to be over $50 billion. Collectively, we estimate these addressable oncology markets represent over $100 billion annually.

The need for comprehensive prenatal testing solutions

In 2023, the U.S.
Center for Disease Control and Prevention (CDC) reported approximately 3.7 million births in the United States, with about one in every 33 infants affected by congenital anomalies. These anomalies can be due to chromosomal abnormalities or
single gene inherited disorders. While existing cfDNA prenatal tests can detect chromosomal abnormalities, they are unable to screen for these inherited single gene conditions, such as sickle cell disease, cystic fibrosis, alpha-thalassemia,
beta-thalassemia and spinal muscular atrophy (SMA). These five recessive conditions are common