Company: BLLN
Filing Date: 2025-08-11
Form Type: DRS/A
Source: 0000950123-25-007483
Chunk: 205

Company: BillionToOne, Inc.
Filing Date: 2025-08-11
Form: DRS/A
Chunk 205
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 leaders in specific disease areas to provide more insights into the validity and utility of Northstar Response. In collaboration with University of Florida, we are conducting a 100-patientprospective study examining the clinical validity of Northstar Response focusing specifically on advanced gastrointestinal tumors. The study completed enrollment in March 2025. In collaboration with University of Miami, we are engaging in a clinical utility study to identify metastatic pancreatic ductal adenocarcinoma (mPDAC) patients who may benefit from ctDNA informed switching to second line chemotherapy based on early measures of response at four weeks following first line treatment initiation. We have also sponsored an investigator-initiated study at the Fred Hutch cancer center to assess the clinical validity of Northstar Response in quantifying therapy response in appendiceal and metastatic peritoneal tumors, which are more difficult to assess by imaging modalities. Additional opportunities in oncology Beyond our two complementary therapy selection and monitoring tests, we are actively advancing our efforts in developing additional oncology products in MRD testing. Our Northstar Response test already achieves 0.01% LOD, which is in line with the first-generation tissue-informed MRD assays. We are making further improvements to the Northstar Response assay designed to achieve superior clinical performance than existing assays using the tumor-naive (blood only) approach. We believe there is a significant market opportunity for tumor-naive MRD assays, especially in certain cancer types such as lung, where the QC failure rates for tissue testing can exceed 40%. 61Longer term, we believe that our smNGS-based technology could address the sensitivity challenges of early-stage cancer detection. We have leveraged our existing relationship with Allegheny Health Network to collaborate on procuring a retrospective sample set to begin assessment of our MRD assay across multiple tumor types including CRC and endometrial cancers. Publications and collaborations We have extensive publications on our smNGS platform and products. Our UNITY Fetal Risk Screen clinical publication in Genetics in Medicine was selected for the Top 10 publications in Genomic medicine year in review 2023 by AJHG. Our hallmark publications in the Obstetrics & Gynecology journal (the Green Journal) demonstrated 100% sensitivity and specificity in approximately 860 patients for fetal RhD and other fetal RBC antigen detection, ultimately leading to the ACOG practice guideline changes. The analytical and clinical validity of our Northstar products have also been demonstrated in peer-reviewed publications. The analytical validation of Northstar Response was published in January 2025 in Scientific Reports while