BillionToOne Announces Dual Launch of UNITY Expanded Red Blood Cell and Platelet Fetal Antigen NIPTs, Extending Its Leadership In Setting the New Standard in Prenatal Care

Rhea-AI Summary

BillionToOne (Nasdaq: BLLN) launched expanded UNITY Red Blood Cell Fetal Antigen NIPT and the first-and-only Platelet Fetal Antigen NIPT in the U.S., available through the UNITY Aneuploidy Screen. The RBC expansion adds 10 antigens, covering ~99% of HDFN-associated antigens. UNITY studies report >99.9% sensitivity and specificity and 100% neonatal concordance, and recent JAMA Network guideline updates endorse cfDNA testing to determine fetal antigen status, reducing unnecessary surveillance for antigen-negative pregnancies. The platelet test addresses FNAIT risk where routine antibody screening is unavailable, enabling non-invasive fetal antigen determination and earlier risk stratification.

Positive

• >99.9% sensitivity and specificity reported for UNITY fetal antigen NIPT
• 100% neonatal concordance reported in UNITY validation studies
• Expanded RBC coverage adds 10 antigens, reaching ~99% of HDFN-associated antigens
• First-and-only Platelet Fetal Antigen NIPT in the U.S. for FNAIT risk stratification
• Addresses 1.5–2.5% of U.S. pregnancies affected or at risk for HDFN/FNAIT

Negative

• None.

Key Figures

Pregnancies at risk: 1.5–2.5% of pregnancies in the U.S. Sensitivity: >99.9% sensitivity Specificity: >99.9% specificity +5 more

8 metrics

Pregnancies at risk 1.5–2.5% of pregnancies in the U.S. Conditions HDFN and FNAIT combined

Sensitivity >99.9% sensitivity UNITY Fetal Antigen NIPT performance

Specificity >99.9% specificity UNITY Fetal Antigen NIPT performance

Outcome concordance 100% concordance Agreement with neonatal outcomes

Added RBC antigens 10 additional red blood cell antigens Expansion of UNITY Fetal Antigen NIPT

Antigen coverage Approximately 99% coverage Antigens associated with HDFN

Price move 6.41% Pre-news 24h price change

Market cap $3,897,209,914 Pre-news valuation

Market Reality Check

Price: $92.37 Vol: Volume 87,160 is below 20...

low vol

$92.37 Last Close

Volume Volume 87,160 is below 20-day average of 224,566 (relative volume 0.39). low

Technical Price at 90.81 is trading below 200-day MA of 96.26 and 34.53% below 52-week high.

Peers on Argus

No peers in the momentum scanner and no same-day peer headlines, suggesting the ...

No peers in the momentum scanner and no same-day peer headlines, suggesting the 6.41% move is stock-specific rather than sector-driven.

Historical Context

5 past events · Latest: 2026-01-15 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
2026-01-15	Tech partnership	Positive	+0.4%	Epic integration to streamline ordering and reporting for UNITY and Northstar tests.
2026-01-12	Guidance update	Positive	+15.4%	Issued 2026 guidance with strong revenue growth and positive GAAP operating outlook.
2026-01-06	Clinical study win	Positive	-0.1%	Northstar Select chosen as liquid biopsy test for LC-SCRUM-TRY at Japanese center.
2025-12-23	Conference participation	Positive	-9.6%	Announcement of participation in the 44th Annual J.P. Morgan Healthcare Conference.
2025-12-09	Board appointment	Positive	+4.7%	Added experienced CFO as audit chair, highlighting governance and growth focus.

Pattern Detected

News flow often aligns with price moves, but there are notable divergences around events like conference participation.

Recent Company History

Over the last few months, BillionToOne reported several positive updates, including 2026 revenue guidance of $415M–$430M implying ~40%–45% growth and a collaboration with Epic to integrate UNITY and Northstar tests. A new director with experience growing revenue from $100M to over $3B joined the board. A clinical study win in Japan slightly pressured shares, while J.P. Morgan conference participation coincided with a -9.57% move. Against this backdrop, today’s product launch extends its prenatal testing franchise.

Market Pulse Summary

This announcement adds expanded UNITY RBC and first-of-its-kind platelet Fetal Antigen NIPTs, report...

Analysis

This announcement adds expanded UNITY RBC and first-of-its-kind platelet Fetal Antigen NIPTs, reporting sensitivity and specificity above 99.9% and coverage of about 99% of HDFN-related antigens. It builds on earlier milestones such as strong 2026 revenue guidance of $415M–$430M and clinical adoption wins. Investors may watch for uptake trends, reimbursement dynamics, and additional guideline endorsements to gauge the commercial impact, as well as how these launches complement the broader UNITY and Northstar diagnostic portfolios over time.

Key Terms

intracranial hemorrhage, thrombocytopenia, nipt

3 terms

intracranial hemorrhage medical

"severe cases leading to intracranial hemorrhage in the fetus"

Bleeding inside the skull—either into the brain itself or into the spaces around it—caused by a burst blood vessel, head injury, or weakened vessels. It matters to investors because it is a serious safety outcome that can halt or delay clinical trials, prompt regulatory warnings or product withdrawals, and significantly affect a company’s development costs and stock value; think of it as a red warning light that can force an expensive stop and fix.

thrombocytopenia medical

"FNAIT, a condition associated with severe neonatal thrombocytopenia and intracranial"

Thrombocytopenia is a medical condition marked by an abnormally low number of platelets, the blood cells that act like a patching crew to stop bleeding. It matters to investors because it can signal safety risks for drugs or procedures, affect clinical trial outcomes, trigger regulatory scrutiny, lead to additional costs or label changes, and influence a company’s stock if treatments must be halted or modified.

nipt medical

"Platelet Fetal Antigen NIPT to enable non-invasive determination of platelet antigen"

Non-invasive prenatal testing (NIPT) is a blood test that screens for certain genetic conditions in a fetus by examining small fragments of the baby’s DNA present in the pregnant person’s blood, avoiding invasive procedures that enter the womb. It matters to investors because test uptake, accuracy, regulatory approval, and pricing determine revenue and margins for companies offering the technology—think of NIPT as a safer, earlier health check (like a smoke alarm for genetic risk) that can drive demand and competitive dynamics in healthcare markets.

AI-generated analysis. Not financial advice.

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.

Media Contact
billiontoone@moxiegrouppr.com 

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SOURCE BillionToOne

FAQ

What did BillionToOne (BLLN) announce on February 9, 2026 about UNITY fetal antigen testing?

BillionToOne announced expanded UNITY RBC Fetal Antigen NIPT and a first-and-only Platelet Fetal Antigen NIPT in the U.S. According to the company, the RBC expansion adds 10 antigens (~99% coverage) and the platelets test enables non-invasive FNAIT risk determination.

How accurate is UNITY fetal antigen NIPT according to BillionToOne (BLLN)?

UNITY fetal antigen NIPT shows very high accuracy, with reported >99.9% sensitivity and specificity. According to the company, validation studies also demonstrated 100% concordance with neonatal outcomes in the evaluated cohorts.

What clinical impact does BillionToOne (BLLN) claim the UNITY tests have on HDFN care?

BillionToOne says UNITY tests redefine care by allowing early antigen-negative determination, sparing unnecessary surveillance. According to the company, recent guideline updates now recommend cfDNA antigen testing and note antigen-negative fetuses need no further surveillance.

How does the new UNITY Platelet Fetal Antigen NIPT affect pregnancies at risk for FNAIT (BLLN)?

The UNITY platelet test enables non-invasive fetal platelet antigen determination to stratify FNAIT risk earlier in pregnancy. According to the company, this fills a gap where routine platelet antibody screening is often unavailable, aiding targeted clinical management.

Which patients could benefit from BillionToOne's (BLLN) expanded UNITY antigen testing?

Pregnancies with alloimmunization risk for red blood cell antigens or suspected platelet incompatibility could benefit from UNITY testing. According to the company, tests help clinicians focus resources on fetuses at true risk and reduce interventions for antigen-negative pregnancies.