Company: BLLN
Filing Date: 2025-10-07
Form Type: S-1
Source: 0001193125-25-233697
Chunk: 226

Company: BillionToOne, Inc.
Filing Date: 2025-10-07
Form: S-1
Chunk 226
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 Reports (Nature Publishing Group)   
 Title: Validation of a non-invasive prenatal test for fetal 
 RhD, C, c, E, K and Fya antigens                            
 Authors: Alford, B., Landry, B.P., Hou, S., et al.          
 Link*:                                                      
 https://doi.org/10.1038/s41598-023-39283-3                  
 Publication Date: August 2023                               |     | This analytical validation study evaluated BillionToOne’s UNITY Fetal Antigen NIPT for detecting fetal red blood cell antigens in                                                                                                                         
 pregnancies at risk for hemolytic disease of the fetus and newborn (HDFN). The methodology used BillionToOne’s proprietary QCT molecular counting technology to analyze fetal antigen genotypes from cell-free DNA as early as 10 weeks gestation,        
 testing samples from alloimmunized pregnancies against RhD, C, c, E, K (Kell), and Fya (Duffy) antigens. Results demonstrated analytical sensitivity and specificity of >99.9% across preclinical and clinical samples, achieving 99.9% precision with    
 only a 0.1% no-call rate. The study showed 100% concordance across clinical samples with known outcomes, representing the lowest no-call rate of any RhD assay and establishing new standards for fetal antigen testing accuracy.                         |
| RhD/Fetal Antigen NIPT Clinical Study                       
 (Obstetrics & Gynecology)                                   
 Publication: Obstetrics & Gynecology (The Green Journal—    
 ACOG Official Journal)                                      
 Title: Cell-Free DNA Analysis for the Determination of      
 Fetal Red Blood Cell Antigen Genotype in Individuals With   
 Alloimmunized Pregnancies                                   
 Authors: Rego, S., Ashimi Balogun, O., Emanuel, K.,         
 Overcash, R., Gonzalez, J.M., Denomme, G.A., Hoskovec, J.,  
 King, H., Wilson, A., Wynn, J., Moise, K.J. Jr.             
 Link*: https://journals.lww.com/greenjournal/abstract/      
 2024/10000/ cell_free_dna_analysis_for_the_                 
 determination_of.7.aspx                                     
 DOI: 10.1097/AOG.0000000000005692                           
 Publication Date: October 2024                              |     | This clinical study demonstrates 100% sensitivity and specificity to correctly call 465 fetal RhD and