BillionToOne Expands Its Leadership in Hemolytic Disease of the Fetus and Newborn (HDFN) and Extends Fetal Antigen Testing to Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
MENLO PARK, Calif., Feb. 9, 2026 /PRNewswire/ — BillionToOne, Inc. (Nasdaq: BLLN), a next-generation molecular diagnostics company with a mission to create powerful and accurate tests that are accessible to all, today announced the launch of UNITY’s expanded Red Blood Cell (RBC) Fetal Antigen NIPT and a first-and-only Platelet Fetal Antigen NIPT. Available exclusively through the UNITY Aneuploidy™ Screen, these offerings represent the first-and-only non-invasive prenatal tests in the U.S. designed to determine fetal antigen status across both red blood cell and platelet antigens in pregnancies affected by or at risk for HDFN and FNAIT. These conditions together affect or place at risk approximately 1.5-2.5% of pregnancies in the U.S., a rate higher than the genetic burden of aneuploidies.
For alloimmunized pregnancies affected by HDFN, clinical evidence from UNITY’s peer-reviewed studies has demonstrated that traditional titer-based monitoring does not reliably determine the fetal risk in antigen-negative pregnancies, frequently leading to unnecessary surveillance and interventions. In contrast, UNITY Fetal Antigen NIPT enables early, accurate determination of fetal antigen status, with studies demonstrating >99.9% sensitivity and specificity and 100% concordance with neonatal outcomes1. This launch expands UNITY Fetal Antigen NIPT to include 10 additional red blood cell antigens, increasing coverage to approximately 99% of antigens associated with HDFN.
UNITY Fetal Antigen NIPT and associated clinical validity and utility publications have already contributed to recent clinical guideline changes, including the recent expert practice guideline update published in JAMA Network. The updated guidelines recommend the use of cfDNA testing to determine fetal antigen status and state that antigen-negative fetuses require no further surveillance for the remainder of pregnancy2. Taken together, UNITY Fetal Antigen NIPT and its ability to definitively determine fetal antigen status have reshaped the standard of care for HDFN, establishing a model BillionToOne is now extending to platelet-mediated disease.
Despite these advances in HDFN care, an even wider gap persists in pregnancies affected by platelet antigen incompatibility where routine antibody screening is unavailable despite severe cases leading to intracranial hemorrhage in the fetus. BillionToOne believes this underserved condition suffers from meaningful clinical gaps and announced a groundbreaking, first-and-only Platelet Fetal Antigen NIPT to enable non-invasive determination of platelet antigen incompatibility for pregnancies with suspected or confirmed risk of FNAIT, a condition associated with severe neonatal thrombocytopenia and intracranial hemorrhage. By providing fetal antigen status for at-risk pregnancies, UNITY Platelet Fetal Antigen NIPT enables proactive risk stratification, serving as a catalyst to bring a much needed innovation in the management of FNAIT.
“We have a proven track record of building tests that close gaps in care and improve clinical decision-making,” said Dr. Oguzhan Atay, Co-Founder and CEO of BillionToOne. “By expanding fetal antigen coverage for HDFN to encompass nearly all clinically relevant antigens, we are delivering more comprehensive and definitive answers earlier in pregnancy. We are also applying the same approach to platelet antigen incompatibility in a first-of-its-kind offering. Together, the expanded UNITY RBC Fetal Antigen NIPT and Platelet Fetal Antigen NIPT provide clarity for pregnant patients who need it the most, with no additional blood draw.”
By enabling early, non-invasive determination of both red blood cell and platelet fetal antigens, UNITY Fetal Antigen NIPTs are setting the new standard in the management of fetal antigen incompatibility, including both HDFN and FNAIT. This approach spares antigen-negative pregnancies from unnecessary surveillance while allowing clinicians to focus attention and resources on fetuses truly at risk, redefining care across the full spectrum of alloimmune fetal conditions.
1Nature Scientific Reports (August 2023) Validation of a non-invasive prenatal test for fetal RhD, C, c, E, K, Fya antigens
2Moise, Kenneth J., Jr., et al. “A Clinical Practice Guideline for the Management of Pregnancy Alloimmunized to Red Blood Cell Antigens.” JAMA Network Open, vol. 8, no. 11, 24 Nov. 2025, e2544649. doi:10.1001/jamanetworkopen.2025.44649
Forward-Looking Statements
This press release contains certain forward-looking statements within the meaning of federal securities laws. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Forward-looking statements in this press release include, but are not limited to, statements regarding the clinical performance of UNITY Fetal Antigen NIPT. These statements are based on management’s current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors, some of which are beyond BillionToOne’s control. These and additional risks and uncertainties that could affect BillionToOne’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. These risks and uncertainties include, but are not limited to, the clinical effectiveness of UNITY Fetal Antigen NIPT those discussed under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in its most recently filed Quarterly Report on Form 10-Q, and other filings the company makes with the Securities and Exchange Commission from time to time. The forward-looking statements in this press release are based on information available to BillionToOne as of the date hereof, and BillionToOne disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing BillionToOne’s views as of any date subsequent to the date of this press release.
About BillionToOne
Headquartered in Menlo Park, California, BillionToOne is a next-generation molecular diagnostics company with a mission to create powerful and accurate tests that are accessible to all. The company’s patented Quantitative Counting Templates™ (QCT™) molecular counting platform is the only multiplex technology that can accurately count DNA molecules at the single-molecule level. For more information, visit www.billiontoone.com.
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