BillionToOne
BillionToOne is a publicly-traded precision diagnostics company that uses its proprietary QCT molecular counting platform to deliver non-invasive prenatal tests (UNITY) and oncology liquid biopsies (Northstar) from a single blood draw to OB/GYNs, maternal-fetal medicine specialists, and oncologists across the United States and Japan.
- Company typePublic
- Founded2016
- HeadquartersMenlo Park, United States
- Headcount501–1,000
- GTM typeB2B
- OfferingServices
What BillionToOne does
BillionToOne, Inc. is a publicly traded precision diagnostics company (NASDAQ: BLLN) headquartered in Menlo Park, California, founded in 2016 by Oguzhan Atay, PhD, and David Tsao, PhD. The company operates two CLIA-certified, CAP-accredited laboratories (Union City, CA for prenatal; Menlo Park, CA for oncology) and is building a third site in Austin, Texas. Its core technology is the patented Quantitative Counting Templates (QCT) molecular counting platform — described as the only multiplex technology that accurately counts DNA molecules at the single-molecule level — which powers a single-molecule NGS (smNGS) workflow for cell-free DNA analysis.
The company's commercial portfolio spans two franchises built on the QCT/smNGS chemistry. The UNITY prenatal franchise offers UNITY Complete (the first NIPT to assess fetal risk for up to 14 recessive and X-linked conditions plus aneuploidies from a single maternal blood draw), UNITY Fetal Antigen NIPTs (red blood cell and platelet antigens, the latter a first-and-only U.S. non-invasive test for FNAIT), and the newly launched Unity Confirm fetal cell-based confirmation test using proprietary Fetal Cell Capture technology. The Northstar oncology franchise offers Northstar Select (an 84-gene comprehensive genomic profiling liquid biopsy detecting SNVs/indels at VAF as low as 0.15%), Northstar Response (a methylation-based treatment response monitoring assay), and add-on modules Northstar PGx and Northstar Select CH. UNITY is used in approximately 1 in 11 U.S. births, and BillionToOne holds roughly 15% of the U.S. prenatal screening market.
BillionToOne generates revenue primarily through per-test diagnostic fees billed to patients, commercial payers, and Medicare. Tests are ordered by healthcare providers (OB/GYNs, MFM specialists, oncologists) via a direct field sales motion and increasingly through Epic's Aura diagnostics suite; reimbursement is supported by Medicare coverage for Northstar Select (MolDx) and an in-network UnitedHealthcare agreement effective April 1, 2026. FY2025 revenue reached $305.1 million (doubling from $152.6 million in FY2024) with 70% gross margins and positive GAAP operating income; the company completed a $314 million Nasdaq IPO in November 2025 at a $4.4 billion valuation and has guided FY2026 revenue to $450-460 million.
BillionToOne firmographics
Firmographics- Name
- BillionToOne
- Legal name
- BillionToOne, Inc.
- Website
- https://billiontoone.com
- Company type
- Public
- Founded year
- 2016
- Operating status
- Ipo
- Headcount range
- 501–1,000 employees
- Short description
- BillionToOne is a publicly-traded precision diagnostics company that uses its proprietary QCT molecular counting platform to deliver non-invasive prenatal tests (UNITY) and oncology liquid biopsies (Northstar) from a single blood draw to OB/GYNs, maternal-fetal medicine specialists, and oncologists across the United States and Japan.
- Ownership category
- akta.pro rank
BillionToOne industry classification
Industry- Product category
- Molecular Diagnostics
- NAICS
- Medical Laboratories (621511), Medical and Diagnostic Laboratories (6215), In-Vitro Diagnostic Substance Manufacturing (325413)
- SIC
- Services-Medical Laboratories (8071), In Vitro & In Vivo Diagnostic Substances (2835)
- akta.pro primary industry
- Genetic & Genomic Testing (germline, somatic, carrier, pharmacogenomics) (HLAAALAD)
- akta.pro secondary industries
- Prenatal, Newborn & Reproductive Diagnostics (NIPT, IVF/PGT, newborn screening) (HLAAALAJ), Oncology Diagnostics (tumor profiling, MRD, liquid biopsy) (HLAAALAE)
Keywords
Where BillionToOne is headquartered
LocationHeadquarters
- HQ city
- Menlo Park
- HQ country
- United States
- HQ region
- North America
Offices4 records
Markets served
BillionToOne business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Technology or R&D, Operations, Marketing or Sales, Infrastructure, Supply Chain
Revenue model
- Diagnostic Test Fees (Prenatal): Per-test revenue from UNITY Complete and other prenatal non-invasive prenatal tests (NIPT). Revenue recognized when tests are processed in the company's CLIA-certified, CAP-accredited laboratories. Tests are ordered by healthcare providers and billed to patients, insurance carriers, or institutional payers. Achieved 15% market share of the estimated $2 billion-plus U.S. prenatal screening market.
- Diagnostic Test Fees (Oncology Liquid Biopsy): Per-test revenue from Northstar Select, Northstar Response, and add-on applications (Northstar PGx, Northstar Select CH). Medicare coverage achieved for Northstar Select via Palmetto GBA/MolDx, and in-network agreement with UnitedHealthcare effective April 1, 2026. Targets the $50 billion-plus oncology testing addressable market.
- Payer Reimbursement: Revenue from third-party payers including Medicare (CMS) and commercial insurers such as UnitedHealthcare. Reimbursement progress has been a key driver of price target upgrades (e.g., Guggenheim raised target to $120 on reimbursement progress).
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | — | Per-test pricing for clinical laboratory diagnostic tests; quote-based, not publicly disclosed |
Go-to-market motion5 records
Distribution channels5 records
Marketing channels6 records
BillionToOne product offering
Product offeringCore offering
BillionToOne develops, validates, and performs proprietary clinical laboratory diagnostic tests that use cell-free DNA and its patented Quantitative Counting Templates (QCT™) molecular counting platform to deliver non-invasive prenatal screening (UNITY Complete and related fetal antigen NIPTs), non-invasive circulating fetal cell-based confirmation (UNITY Confirm), and oncology liquid biopsy tests (Northstar Select comprehensive genomic profiling and Northstar Response treatment-response monitoring). Tests are processed in the company's CLIA-certified, CAP-accredited laboratories in Union City, California (prenatal) and Menlo Park, California (oncology), and are ordered by healthcare providers and reimbursed through patients, commercial insurers, and Medicare.
Product overview
BillionToOne offers a single underlying molecular counting platform (QCT™ / smNGS) that powers two product families addressing two clinical segments. On the prenatal side, the Unity franchise (Unity Complete / Unity Aneuploidy Screen, the expanded Unity Fetal Antigen NIPTs for RBC and platelet antigens, and the newly launched Unity Confirm fetal-cell-based confirmation test) delivers non-invasive prenatal screening and now diagnostic-grade confirmation from a single maternal blood draw. On the oncology side, the Northstar franchise (Northstar Select comprehensive genomic profiling liquid biopsy and Northstar Response methylation-based treatment-response monitoring, plus add-ons Northstar PGx and Northstar Select CH) uses the same QCT smNGS chemistry to guide therapy selection and monitor response from a single blood draw. Both product families are supported by a CAP-accredited, CLIA-certified laboratory network in Union City, CA (prenatal) and Menlo Park, CA (oncology) and are integrated into Epic's Aura diagnostics suite for in-EHR ordering and result delivery.
Differentiator
Problem solved
Functional benefit
Brands
- UNITY: Prenatal non-invasive prenatal testing (NIPT) product line including Unity Complete, Unity Screen (UNITY Aneuploidy Screen), Unity Confirm, and Unity Fetal Antigen NIPTs for assessing aneuploidies, recessive conditions, and fetal antigens from a maternal blood draw.
- Northstar
Products and services
- Unity Complete Unity Complete® is the first non-invasive prenatal test (NIPT) to use cfDNA to assess fetal risk for up to 14 recessive and X-linked conditions, aneuploidies, and fetal antigens from a single maternal blood sample at 9+ weeks of pregnancy; it does not require a paternal blood sample.
- Unity Confirm Unity Confirm™ is a non-invasive circulating fetal cell-based prenatal confirmation test that uses BillionToOne's Fetal Cell Capture™ technology (multi-step immunological enrichment, single-cell isolation, and whole genome sequencing) to provide diagnostic-level insights for high-risk UNITY Aneuploidy Screen results without invasive procedures; demonstrated 100% concordance with invasive diagnostics across 16 samples.
- UNITY Expanded Red Blood Cell Fetal Antigen NIPT UNITY's expanded Red Blood Cell Fetal Antigen NIPT determines fetal antigen status across approximately 99% of antigens associated with hemolytic disease of the fetus and newborn (HDFN); available exclusively through the UNITY Aneuploidy Screen with no additional blood draw.
- UNITY Platelet Fetal Antigen NIPT The first-and-only non-invasive prenatal test in the U.S. for determining fetal platelet antigen status in pregnancies at risk for fetal and neonatal alloimmune thrombocytopenia (FNAIT), a condition that can cause severe neonatal thrombocytopenia and intracranial hemorrhage.
- Northstar Select Northstar Select® is an ultra-sensitive 84-gene single-molecule NGS comprehensive genomic profiling (CGP) liquid biopsy assay for therapy selection in patients with advanced solid tumors; detects SNVs and indels at variant allele frequencies as low as 0.15% (95% LoD) and is delivered with a 5-day average turnaround time.
- Northstar Response Northstar Response® is a tissue-free, methylation-based pan-cancer assay that monitors treatment response by measuring changes in circulating tumor-derived signals over time with single-molecule precision, often months ahead of imaging.
Quantifiable outcome
- 100% concordance with invasive diagnostic results across 16 samples in Unity Confirm clinical validation
- +9 more outcomes
Companies that use BillionToOne
Customer profileNamed customers2 records
Ideal customer profiles2 records
BillionToOne technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Integration1 record
AI capability4 records
Feature5 records
BillionToOne partnerships and signals
Strategic signalPartnerships
Seven partnerships are on record, tiered flagship and moderate.
- UnitedHealthcareflagshipSigned in-network agreement with UnitedHealthcare effective April 1, 2026. Improves patient access to BillionToOne tests and increases test prices for UnitedHealthcare-insured patients. Announced alongside Q4 2025 earnings results on March 4, 2026. Expands commercial insurance coverage footprint.
- Epic SystemsflagshipCollaboration to integrate BillionToOne's prenatal (UNITY Complete) and oncology testing portfolio (Northstar Select, Northstar Response) with Epic's Aura diagnostics suite. Agreement signed December 2025, announced January 15, 2026. Epic is described as 'the nation's most widely used comprehensive electronic health record.' Clinicians can order BillionToOne tests directly within Epic; discrete results flow back into EHR and MyChart patient portal. Quote from Seth Hain (SVP R&D, Epic): 'BillionToOne's use of Aura integrates oncology and prenatal tests and results where they matter—inside the clinician's workflow, at the moment of decision.'
- National Cancer Center Hospital East (NCCHE)flagshipBillionToOne's Northstar Select® liquid biopsy test was selected as the new liquid biopsy for the LC-SCRUM-TRY nationwide multi-center study in Japan. The study analyzes approximately 2,000 clinical specimens from patients with advanced or recurrent NSCLC. Selected after demonstrating higher sensitivity than a previously used assay in head-to-head validation against paired tumor tissue and plasma samples from ~1,000 patients. Quote from Koichi Goto, MD, PhD (Deputy Director, NCCHE). Northstar Select detection at VAF as low as 0.15% (95% LoD) was a key differentiator.
- Greenberg Traurig, LLPmoderateRepresented BillionToOne Inc. in its $314M IPO completed November 7, 2025. Shares surged 82% on first trading day. Legal counsel for IPO transaction.
- Gunderson DettmermoderateRepresented long-time client BillionToOne in its upsized $273.1 million IPO, which began trading on the Nasdaq on November 6, 2025. Issued 4.6 million shares at $60 each.
- Medicare (CMS) via Palmetto GBA / MolDxflagshipNorthstar Select® met Medicare coverage criteria established by Palmetto GBA, a Medicare administrative contractor that administers the Molecular Diagnostics Services program (MolDx), following rigorous review of evidence demonstrating analytical validity, clinical validity, and clinical utility. Helps ensure more patients with advanced cancer can benefit from personalized treatment approaches.
- Johnson & JohnsonflagshipPartnership mentioned in CEO Oguzhan Atay's Founders Letter with the potential to enable a therapy for hemolytic disease in fetuses and newborns (HDFN), a high-risk condition that can result in fetal death. Strategic collaboration in prenatal therapeutics area.
Scale indicators16 records
Recent moves8 records
Expansion highlights5 records
BillionToOne competitors and assessment
Company assessmentDirect peers
- Natera: Natera is the most direct competitor to BillionToOne's UNITY prenatal NIPT franchise (Vistara, Panorama) and is also a major oncology testing player (Signatera MRD). Both companies serve OB/GYNs, MFMs, and oncologists with cfDNA-based tests and compete head-to-head for the same U.S. prenatal market share BillionToOne now claims 15% of.
- Guardant Health: Guardant Health is a leading liquid biopsy competitor to BillionToOne's Northstar Select, offering Guardant360 CDx for comprehensive genomic profiling in advanced solid tumors. Both companies target oncologists with cfDNA-based CGP tests and compete for Medicare MolDx coverage and pharma partnerships.
- NeoGenomics: NeoGenomics is a CLIA-certified oncology diagnostics laboratory offering solid tumor and liquid biopsy profiling, including its RaDaR MRD assay. It is a direct comparable as a clinical lab services provider in oncology competing for the same oncologist relationships and reimbursement pathways.
- Veracyte: Veracyte is a genomic diagnostics company offering Afirma (thyroid), Decipher Prostate, and Prosigna breast cancer tests. It is comparable to BillionToOne as a specialty molecular diagnostics company targeting oncologists with tissue and blood-based genomic tests for therapy selection.
- Tempus AI: Tempus AI offers comprehensive genomic profiling (xT, xR), liquid biopsy (xF), and AI-enabled precision medicine solutions to oncologists. It is a direct comparable as a technology-forward precision oncology diagnostics competitor with overlapping products and target customers.
Broad incumbents
- Exact Sciences: Exact Sciences is a larger molecular diagnostics incumbent offering Cologuard (colorectal cancer screening) and the Oncotype DX franchise for oncology therapy selection. It is a broad incumbent in the same genomic diagnostics space BillionToOne operates in, with much larger scale and broader payor coverage.
- Myriad Genetics: Myriad Genetics is an established genetic testing incumbent offering hereditary cancer (BRACAnalysis), prenatal (Prequel, Foresight), and oncology tests. It is comparable to BillionToOne as a diversified genetic diagnostics company serving OB/GYNs and oncologists, though with a broader legacy test portfolio.
- Foundation Medicine (Roche): Foundation Medicine, owned by Roche, offers FoundationOne CDx (tissue CGP) and FoundationOne Liquid CDx, the entrenched tissue-and-blood CGP incumbents in oncology. It is a broad incumbent that BillionToOne's Northstar Select must displace in academic and community oncology settings.
Emerging players
- Personalis: Personalis is a smaller cancer genomics competitor offering NeXT Personal (tumor-informed MRD) and other ultra-sensitive ctDNA tests. It is comparable to BillionToOne's Northstar Response for treatment response monitoring, though with a narrower oncology-only focus and smaller commercial scale.
- Adaptive Biotechnologies: Adaptive Biotechnologies offers clonoSEQ (MRD) and immune repertoire sequencing for oncology and immune-driven diseases. It is comparable to BillionToOne as an emerging molecular diagnostics company applying novel genomic platforms (immunosequencing vs. QCT molecular counting) to clinical oncology use cases.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat6 records
Key risks6 records
Key highlights6 records
Customer concentration
BillionToOne social profiles
Digital presenceBillionToOne compliance and trust
Trust signalCompliance9 records
BillionToOne financial estimates
Financial estimateRevenue estimate
Valuation estimate
BillionToOne leadership team
Management profileNumber of profiles
Profiles10 records
BillionToOne funding detail
Funding detailFunding overview
Funding rounds8 records
Investors31 records
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BillionToOne M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about BillionToOne
What does BillionToOne do?
BillionToOne develops, validates, and performs proprietary clinical laboratory diagnostic tests that use cell-free DNA and its patented Quantitative Counting Templates (QCT™) molecular counting platform to deliver non-invasive prenatal screening (UNITY Complete and related fetal antigen NIPTs), non-invasive circulating fetal cell-based confirmation (UNITY Confirm), and oncology liquid biopsy tests (Northstar Select comprehensive genomic profiling and Northstar Response treatment-response monitoring). Tests are processed in the company's CLIA-certified, CAP-accredited laboratories in Union City, California (prenatal) and Menlo Park, California (oncology), and are ordered by healthcare providers and reimbursed through patients, commercial insurers, and Medicare.
Is BillionToOne a public or private company?
BillionToOne is a public company. It is classified as public and is currently ipo.
When was BillionToOne founded?
BillionToOne was founded in 2016. It employs 501 to 1,000 people.
Where is BillionToOne based?
BillionToOne is headquartered in Menlo Park, United States, in the North America region.
How does BillionToOne make money?
Three revenue lines are on record. Diagnostic Test Fees (Prenatal) is the primary driver. The others are diagnostic Test Fees (Oncology Liquid Biopsy) and payer Reimbursement.
Who are BillionToOne's main competitors?
Direct peers on record are Natera, Guardant Health, NeoGenomics, Veracyte and Tempus AI. Broad incumbents are Exact Sciences, Myriad Genetics and Foundation Medicine (Roche). Emerging players are Personalis and Adaptive Biotechnologies.
Does BillionToOne have an API?
No public API is recorded for BillionToOne.
What industry is BillionToOne in?
BillionToOne's product category is Molecular Diagnostics. Its primary akta.pro industry code is HLAAALAD, Genetic & Genomic Testing (germline, somatic, carrier, pharmacogenomics), with a secondary code of HLAAALAJ, Prenatal, Newborn & Reproductive Diagnostics (NIPT, IVF/PGT, newborn screening). Its NAICS code is 621511 and its SIC code is 8071.