Company: BLLN
Filing Date: 2025-10-07
Form Type: S-1
Source: 0001193125-25-233697
Chunk: 202

Company: BillionToOne, Inc.
Filing Date: 2025-10-07
Form: S-1
Chunk 202
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 for our prenatal products to be over $2.5 billion annually in the United States. 48 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. 49We also plan to expand our product portfolio and are developing a tissue-free, pan-cancerMRD 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. 48Longer term, we believe that our smNGS-based technology could address the sensitivity challenges of early-stage cancer detection. While we have not yet started development in this area, the research work that we have done for Northstar Response and MRD is a necessary precursor for early detection development. In particular, we believe that a sensitive tissue-free MRD test, which we have already de-risked by the recent launch of an ultra-sensitive response monitoring assay (Northstar Response v2), which can detect tumor DNA in blood down to a limit of detection (LOD) of 0.01%, can be technically equivalent to an early detection test for cancer. 50We 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. 48

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 commonly-used 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, clinically actionable, and recommended for universal screening by ACOG, with one in six pregnant individuals in the United States being a