Company: BLLN
Filing Date: 2025-09-17
Form Type: DRS/A
Source: 0001193125-25-206347
Chunk: 201

Company: BillionToOne, Inc.
Filing Date: 2025-09-17
Form: DRS/A
Chunk 201
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 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 83% revenue growth rate to $209 million in the 12-monthperiod ended June 30, 2025 from the preceding 12-monthperiod. We estimate the market opportunity 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