BillionToOne Launches Unity Confirm™: A category-defining test that bridges the gap between screening and invasive diagnostics

Rhea-AI Summary

BillionToOne (Nasdaq: BLLN) launched Unity Confirm on May 1, 2026, a circulating fetal cell–based non‑invasive confirmation test that analyzes intact fetal cells from a maternal blood draw.

In internal validation, Unity Confirm showed 16/16 concordance with invasive diagnostic outcomes; access opens May 28 for Unity Aneuploidy users and a 1,000‑patient prospective study is enrolling.

AI-generated analysis. Not financial advice.

Positive

• 16/16 concordance with invasive diagnostic outcomes in internal validation
• Access for Unity Aneuploidy providers begins on May 28, 2026
• Launching a 1,000‑patient prospective study to measure concordance to invasive diagnostics
• Cell-based capture yields effectively 100% fetal fraction when isolated

Negative

• Unity Confirm is a laboratory‑developed test and is not FDA approved or cleared
• Test may produce false positives and false negatives; results are not a guarantee
• Available only to pregnancies screened with Unity Aneuploidy as the frontline test
• In rare cases, single‑cell co‑sequencing with maternal cells can reduce fetal fraction to 50% or 33%

News Market Reaction – BLLN

-6.93%

1 alert

-6.93% News Effect

On the day this news was published, BLLN declined 6.93%, reflecting a notable negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Prior cell-based studies: more than 1,500 patients Concordance in validation: 100% concordance (16 of 16 samples) Prospective study size: 1,000 patients +5 more

8 metrics

Prior cell-based studies more than 1,500 patients Independent cell-based prenatal genetics studies cited in sources

Concordance in validation 100% concordance (16 of 16 samples) BillionToOne’s own clinical validation of Unity Confirm

Prospective study size 1,000 patients Target enrollment for largest prospective fetal cell-based confirmation study

Fetal cell rarity fewer than one cell per milliliter Frequency of intact circulating fetal cells in maternal blood

Fetal fraction level effectively 100% fetal fraction Unity Confirm fetal fraction when isolating intact fetal cells

Reduced fetal fraction cases 50% or 33% fetal fraction When one fetal cell is co-sequenced with 1–2 maternal cells

Gestational limit before 16 weeks of gestation Intended use window after high-risk Unity Aneuploidy Screen

Available conditions 7 aneuploidies/microdeletions Trisomies 21, 18, 13; 22q11.2; XXY, XYY, XXX

Market Reality Check

Price: $92.96 Vol: Volume 312,703 is below t...

normal vol

$92.96 Last Close

Volume Volume 312,703 is below the 20-day average of 400,333 (relative volume 0.78). normal

Technical Shares at 77.49 trade below the 200-day MA of 88.07 and about 44.13% under the 52-week high of 138.7.

Peers on Argus

No peers from the Diagnostics & Research group appeared in the momentum scan, su...

No peers from the Diagnostics & Research group appeared in the momentum scan, suggesting today’s 3.25% move is stock-specific rather than a sector-wide rotation.

Historical Context

5 past events · Latest: Apr 15 (Neutral)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Apr 15	Earnings date notice	Neutral	-2.6%	Announcement of Q1 2026 earnings release date and conference call logistics.
Apr 02	Leadership / clinical	Positive	-4.3%	Appointment of VP Medical Affairs & Clinical Development to lead oncology portfolio.
Mar 04	Earnings and guidance	Positive	-10.7%	Strong Q4/FY 2025 results, higher 2026 revenue guidance, and profitability milestones.
Feb 17	Earnings date notice	Neutral	+5.2%	Scheduling of Q4/FY 2025 results release and investor conference call.
Feb 10	Product expansion	Positive	-0.5%	Launch of two new liquid biopsy add-ons to the Northstar Select platform.

Pattern Detected

Recent history shows multiple positive operational updates followed by negative price reactions, indicating a tendency for the stock to sell off on good news.

Recent Company History

Over the last few months, BillionToOne has combined strong execution with active product development. On Mar 4, 2026, it reported Q4 and FY 2025 results with revenue doubling to $305.1M and raised 2026 guidance, yet the stock fell 10.71%. Earlier, on Feb 10, 2026, the company expanded its Northstar platform, and on Apr 2, 2026, it strengthened oncology leadership. Today’s Unity Confirm launch continues that pattern of major portfolio expansion in prenatal diagnostics.

Market Pulse Summary

The stock moved -6.9% in the session following this news. A negative reaction despite this launch wo...

Analysis

The stock moved -6.9% in the session following this news. A negative reaction despite this launch would fit a pattern where BLLN has previously sold off on positive updates, including strong Q4 2025 results and raised 2026 guidance. Unity Confirm adds a differentiated, non-invasive confirmation test with 100% concordance in early validation and a planned 1,000-patient study. Execution on clinical adoption, study outcomes, and reimbursement would remain key factors for long-term impact.

Key Terms

cell-free dna, non-invasive prenatal testing, chorionic villus sampling, amniocentesis, +4 more

8 terms

cell-free dna medical

"While cell-free DNA has revolutionized prenatal genetics, it left an uncertainty—"

Fragments of DNA that float freely in the bloodstream after being released by dying or damaged cells, like puzzle pieces carried downstream that hint at what’s happening upstream. Investors care because measuring these fragments enables non‑invasive tests — for example to detect cancer, monitor treatment response, check pregnancy health, or spot organ rejection — so advances, approvals, or reimbursement changes can quickly affect companies that develop the tests and related technologies.

non-invasive prenatal testing medical

"Since its introduction in the early 2010s, non-invasive prenatal testing (NIPT) has"

A blood test given to pregnant people that reads small amounts of fetal genetic material circulating in the mother’s bloodstream to screen for common chromosomal conditions such as Down syndrome without entering the body. Think of it as a noninvasive snapshot that replaces riskier procedures for initial screening, so investors watch it because uptake, accuracy, regulation and insurance coverage directly affect demand, revenue potential and competitive dynamics in prenatal diagnostics.

chorionic villus sampling medical

"clinical guidelines recommend diagnostic confirmation via chorionic villus sampling (CVS)"

Chorionic villus sampling is a prenatal medical procedure that takes a tiny sample of tissue from the placenta to check a fetus’s chromosomes and certain genetic conditions early in pregnancy, similar to taking a small snapshot of the baby’s genetic makeup. For investors, it matters because demand, regulatory approval, coverage by insurers, and technological changes in this test can affect revenue, clinical pipelines and competitive positioning for companies in diagnostics and prenatal care.

amniocentesis medical

"clinical guidelines recommend diagnostic confirmation via chorionic villus sampling (CVS) or amniocentesis."

Amniocentesis is a prenatal medical test in which a thin needle withdraws a small sample of the fluid that surrounds a fetus so cells and chemicals can be examined for genetic conditions or developmental problems. Think of it as taking a teaspoon from a soup to check if an ingredient is missing. For investors, results, demand for testing, and regulatory decisions can affect companies that make diagnostic tests, lab services, medical devices, and related health coverage.

whole genome sequencing medical

"and performs whole genome sequencing on each individual cell."

Whole genome sequencing is a laboratory method that reads an individual’s complete DNA instruction book, capturing all genetic letters rather than just selected parts. For investors, it matters because it can reveal new ways to diagnose, prevent or treat disease and to develop tests or drugs — like upgrading from a map of a few streets to a full city blueprint — which can create commercial opportunities, influence regulatory pathways and change healthcare costs and demand.

fish medical

"whereas rapid CVS is often performed via FISH."

Fluorescence in situ hybridization (FISH) is a lab technique that uses glowing DNA probes to find specific genetic changes inside cells, like locating a particular page in a thick book by shining a light on matching words. Investors care because FISH results can confirm whether a disease has a genetic marker linked to diagnosis, prognosis, or response to a drug, which can affect clinical value, regulatory decisions, and market potential.

laboratory-developed test regulatory

"Unity Confirm is a laboratory-developed test performed in a CLIA-certified"

A laboratory-developed test is a diagnostic test that a single clinical laboratory designs, builds and uses in its own facility rather than buying from an outside manufacturer; think of it as a custom recipe made and run in-house for diagnosing disease. Investors care because these tests can be quicker to bring to market and create a revenue stream for labs, but they also carry regulatory and quality-risk differences that can affect demand, reimbursement and legal exposure.

clia-certified regulatory

"Unity Confirm is a laboratory-developed test performed in a CLIA-certified and CAP-accredited laboratory."

CLIA-certified means a laboratory has passed U.S. federal standards for performing tests on human samples, showing its results are accurate, reliable and timely. For investors this matters because certification is often required to sell clinical test services, bill insurers, win hospital or physician partnerships and avoid regulatory penalties — much like a restaurant passing a health inspection or a car getting a safety sticker before it can be sold.

AI-generated analysis. Not financial advice.

A breakthrough in prenatal care, Unity Confirm enables non-invasive confirmation for high-risk screening results through the capture of intact circulating fetal cells using BillionToOne's Fetal Cell Capture™ Technology

MENLO PARK, Calif., May 1, 2026 /PRNewswire/ -- For more than two decades, the ultimate quest for scientists and clinicians studying prenatal genetics was the capture of an intact fetal cell non-invasively so that its fetal DNA could be directly analyzed. While cell-free DNA has revolutionized prenatal genetics, it left an uncertainty—a gap between screening and invasive diagnostics, for patients who cannot, or choose not to, access invasive diagnostics. Today, BillionToOne, Inc. (Nasdaq: BLLN), a next-generation molecular diagnostics company with a mission to create powerful and accurate tests that are accessible to all, announced the launch of Unity Confirm™, a circulating fetal cell-based, non-invasive confirmation test, designed to address this need from a simple maternal blood draw.

Since its introduction in the early 2010s, non-invasive prenatal testing (NIPT) has become the standard of care for screening for fetal aneuploidies. However, when screening returns a high-risk result, clinical guidelines recommend diagnostic confirmation via chorionic villus sampling (CVS) or amniocentesis. These invasive procedures carry a small but real risk of pregnancy loss, and are increasingly difficult to access. The majority of patients decline, leaving clinicians and families without the information needed to guide next steps, and widening gaps in inequitable care.

While cell-based prenatal genetics has been studied since before the advent of cell-free DNA tests, the scientific barrier has long been the rarity and fragility of fetal cells in maternal circulation. Presenting at fewer than one cell per milliliter of blood and nearly indistinguishable from millions of surrounding maternal cells, intact circulating fetal cells have been too difficult to isolate in an accessible way for clinical use. The cell-based approaches were previously studied across multiple independent publications¹ in more than 1,500 patients, consistently demonstrating that when a fetal cell is captured and sequenced, it provides an accurate result that has extremely high concordance with invasive diagnostic testing. However, these methodologies have stayed too academic, expensive, and inaccessible.

Unity Confirm addresses this directly. Available for all patients who use UNITY Aneuploidy for their front-line screen*, BillionToOne's Fetal Cell Capture™ technology, a multi-step immunological enrichment and single cell isolation process, isolates intact circulating fetal cells, effectively providing 100% fetal fraction², and performs whole genome sequencing on each individual cell. By analyzing the direct fetal cells rather than fragmentary cfDNA, similar to invasive procedures, Unity Confirm delivers rapid CVS-like insights³ non-invasively, from a single blood draw.

"For years, the idea of capturing whole fetal cells non-invasively was largely viewed as an elusive holy grail, something theoretically possible but practically out of reach," said Oguzhan Atay, PhD, Co-founder and CEO of BillionToOne. "Unity Confirm is proof that it does not have to be. For the first time, a clinician can confirm a high-risk prenatal result non-invasively, with a level of accuracy the field has never before seen outside of an invasive procedure. For the first time, this technology is broadly accessible."

"A high-risk NIPT result does not give you a diagnosis. It gives you a decision to make under enormous stress, often without enough information," said Haywood Brown, MD, Chief Medical Officer, Prenatal, BillionToOne. "For too long, the options were limited: forgo confirmation, or undergo an invasive procedure with a small but real risk. What makes Unity Confirm truly different is not just the science; it is that this capability is now clinically accessible. That's not an incremental improvement. That is a fundamentally different standard of care."

In BillionToOne's own clinical validation, Unity Confirm demonstrated 100% concordance with known fetal outcomes and invasive diagnostic results across 16 of 16 samples, including affected fetuses for common aneuploidies and 22q11.2 microdeletion. The clinical data supporting Unity Confirm will be presented at ACOG 2026 in Washington, D.C., presenting the science behind the technology to the broader OB/GYN community for the first time. Beginning on May 28, providers using Unity Aneuploidy™ Screen will have access to Unity Confirm following a high-risk result. To further validate performance at scale, BillionToOne is now enrolling in the largest prospective study of a fetal cell-based confirmation assay with invasive diagnostic outcomes, targeting enrollment of 1,000 patients and measuring concordance to invasive diagnostic testing.

*Unity Confirm is intended for patients who cannot, or choose not to, pursue invasive diagnostic testing following a high-risk Unity Aneuploidy Screen result before 16 weeks of gestation. Available for Trisomy 21 (Down syndrome), Trisomy 18, Trisomy 13, 22q11.2 microdeletion, XXY, XYY, and XXX aneuploidies. Requires Unity Aneuploidy Screen as the frontline screen for the pregnancy.

Sources

¹Hatt, Lotte, et al. "A new marker set that identifies fetal cells in maternal circulation with high specificity." Prenatal Diagnosis 34.11 (2014): 1066-1072.; Stampalija, T., et al. "Single-cell-based non-invasive screening for fetal pathogenic microimbalances using maternal blood: comparison with invasive prenatal diagnosis." Ultrasound in Obstetrics & Gynecology (2026).; Weymaere, Jana, et al. "Enrichment of circulating trophoblasts from maternal blood using filtration-based Metacell® technology." Plos one 17.7 (2022):e0271226.; Jeppesen, Line Dahl, et al. "Screening for Fetal Aneuploidy and Sex Chromosomal Anomalies in a Pregnant Woman with Mosaicism for Turner Syndrome—Applications and Advantages of Cell-Based NIPT." Frontiers in Genetics 12 (2021): 741752.; Bellair, Michelle, et al. "Noninvasive single-cell-based prenatal genetic testing: A proof of concept clinical study." Prenatal Diagnosis 44.3 (2024):304-316.; Chakchouk, Imen, and Ignatia B. Van den Veyver. "Whole-Genome Amplification on Single Circulating Trophoblast Cell." Whole Genome Amplification: Methods and Protocols. New York, NY: Springer US, 2026. 11-23.; Zhuo, Xinming, et al. "Use of amplicon-based sequencing for testing fetal identity and monogenic traits with Single Circulating Trophoblast (SCT) as one form of cell-based NIPT." PLoSOne 16.4 (2021): e0249695.

²In rare instances, results may rely on a single cell that is co-sequenced with 1-2 maternal cells, which may reduce fetal fraction to 50% or 33%. When this occurs, the report clearly indicates this limitation.

³Unity Confirm and rapid CVS both analyze fetal-derived trophoblast cells. Unity Confirm isolates individual cells via whole genome sequencing (WGS), which is performed on each cell separately, whereas rapid CVS is often performed via FISH. While rapid CVS may analyze more cells, WGS generates more data per cell. In both rapid CVS and fetal cell capture, mosaicism cannot be excluded. Unity Confirm may have false-positive and false-negative results. Results are not a guaranty. Important medical decisions should not rely on UnityConfirm test results alone. Clinical correlation is necessary. Unity Confirm is a laboratory-developed test performed in a CLIA-certified and CAP-accredited laboratory. It is not an FDA-approved or FDA-cleared diagnostic test. Test performance may vary based on gestational age and other factors.

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 effectiveness of Unity Confirm. 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 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 risk that Unity Confirm is not clinically effective and not  adopted by healthcare professionals and those discussed under the captions "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operation" and elsewhere in BillionToOne's most recently filed Annual Report on Form 10-K, and other filings we make 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 is Unity Confirm from BillionToOne (BLLN) and how does it work?

Unity Confirm is a non‑invasive fetal cell confirmation test using maternal blood to isolate intact fetal cells. According to the company, it uses Fetal Cell Capture™ and whole‑genome sequencing on individual cells to provide confirmation similar to CVS without an invasive procedure.

When will Unity Confirm be available to providers who use UNITY Aneuploidy (BLLN)?

Providers using UNITY Aneuploidy can access Unity Confirm beginning May 28, 2026. According to the company, the option follows a high‑risk Unity Aneuploidy result for patients who cannot or choose not to pursue invasive testing.

How accurate is Unity Confirm compared with invasive diagnostic testing for prenatal aneuploidies?

In BillionToOne’s internal validation, Unity Confirm showed 100% concordance across 16 of 16 samples with known invasive diagnostic outcomes. According to the company, a larger 1,000‑patient prospective study is enrolling to validate performance at scale.

Does Unity Confirm have regulatory clearance and what are its limitations for BLLN investors?

Unity Confirm is a CLIA/CAP laboratory‑developed test and is not FDA approved or cleared. According to the company, results may vary with gestational age, can include false positives/negatives, and should not be the sole basis for major medical decisions.