Northstar PGx
Pharmacogenomic testing for chemotherapy safety from the same blood draw
Software · OtherCompany source
Company profile
About BillionToOne
BillionToOne is a next-generation molecular diagnostics company headquartered in Menlo Park, California, with a mission to create powerful and accurate tests that are accessible to all. The company has developed a proprietary Quantitative Counting Templates (QCT™) platform that powers its single-molecule next-generation sequencing (smNGS) technology, enabling direct measurement of sparse disease-causing DNA fragments at the single base-pair level. The company operates in two primary areas: prenatal screening and oncology. In prenatal care, Unity Complete® is the first non-invasive prenatal test (NIPT) that uses cell-free DNA to assess fetal risk for recessive conditions and aneuploidy from a single maternal blood sample as early as 9 weeks, identifying approximately 3x more affected pregnancies than traditional screening without requiring a partner sample. The Unity platform has expanded to include Unity Confirm™, Unity Expanded Red Blood Cell, and Platelet Fetal Antigen NIPTs. In oncology, BillionToOne offers the Northstar platform, which includes Northstar Select® for therapy selection and Northstar Response® for treatment monitoring. Northstar Select is demonstrated to uncover approximately 50% more clinically actionable alterations than other ctDNA tests in head-to-head studies. The platform has been expanded with Northstar PGx™ for pharmacogenomic insights and Northstar Select CH™ for clonal hematopoiesis detection. The company's technology enables tracking of tumor burden changes down to 0.01% tumor fraction without requiring tissue samples. Founded by co-founders Oguzhan Atay, PhD, and David Tsao, PhD, BillionToOne operates CLIA-certified and CAP-accredited laboratories in Union City and Menlo Park, California. The company has established partnerships with major healthcare systems through Epic EMR integration and collaborates with leading research institutions including the National Cancer Center Hospital East in Japan.
Company description BillionToOne official website
Primary marketPrecision Medicine & Genomics
Commercial modelCommercial information available on request
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01 · Operating footprint
Where the Company operates
Company-profile context for clinical focus, customers, deployment, integration, milestones, and partnerships.
Clinical focus
- Advanced solid tumors
- Aneuploidies
- Clonal hematopoiesis
- DPD deficiency
- Fetal antigen incompatibilities
- Pan-cancer applications
- Recessive genetic conditions
Who it serves
- Cancer centers
- Healthcare providers
- Hospitals
- OB/GYN practices
- Oncology clinics
Deployment & integration
Other deployment with recorded integration context.
Recorded integration context: Epic.
Geographic context
MarketsJapan · United States
Company sourceOfficial website
Company milestones
Platform expansion
Q1 2026 revenue guidance raised; Unity Confirm™ launched May 2026; Northstar PGx and Northstar Select CH launched February 2026; Unity Expanded RBC and Platelet Fetal Antigen NIPTs launched February 2026; Epic collaboration announced January 2026; Northstar Select selected for LC-SCRUM-TRY study January 2026
Partnerships
Recorded partners
- Epic
- LC-SCRUM-TRY clinical study
- National Cancer Center Hospital East (Japan)
02 · Flagship portfolio
Products, workflows, and platform capabilities
Selected source-backed Company products and the available commercial context.
Northstar Response
Real-time treatment monitoring tracking tumor burden down to 0.01% tumor fraction
Software · OtherCompany source
Northstar Select
Most sensitive liquid biopsy for therapy selection, uncovering 50%+ more actionable alterations
Software · OtherCompany source
Northstar Select CH
Clonal hematopoiesis detection achieving 99%+ accuracy in distinguishing tumor-derived alterations
Software · OtherCompany source
Unity Complete
First NIPT assessing fetal risk for recessive conditions and aneuploidy from single maternal blood sample
Software · OtherCompany source
Unity Confirm
Category-defining test bridging the gap between screening and invasive diagnostics
Software · OtherCompany source
Unity Expanded Red Blood Cell and Platelet Fetal Antigen NIPTs
Expanded prenatal testing for red blood cell and platelet fetal antigens
Software · OtherCompany source
03 · Research intelligence
Research Intelligence evidence
Publications, preprints, clinical validation, and regulatory records in Evidence Position order.
Evidence position
Publications, clinical validation, and regulatory records connected to this Company appear here.
Research
Publications & preprints
Longitudinal methylated ctDNA increases predict immunotherapy progression across solid tumors.The journal of liquid biopsy · Sep 1, 2026
A Prospective, Multi-Site Study of Performance of Cell-Free DNA Testing for Recessive Conditions in a Large, General-Risk Pregnancy Population.Obstetrics and gynecology · Aug 13, 2026
Important Limitations on the Conclusions of "Discrepant Results on Two Different Single Gene Noninvasive Prenatal Tests for Cystic Fibrosis: A Case Report".AJP reports · Jul 1, 2026
Unique social, identity, and community factors impact prophylactic surgery discussions in young adults who are BRCA1, BRCA2, and PALB2 positive.Journal of genetic counseling · Apr 1, 2026
Response to Zemanick et al., "false reassurance following single gene non-invasive prenatal testing for cystic fibrosis".Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society · Jan 1, 2026
Overcoming the eIF2α Brake in Human Cell-Derived Translation Systems.bioRxiv : the preprint server for biology · Dec 7, 2025
Clinical validation
Clinical-trial records
The ADVANCE (Assay Development and Validation for Pre-Natal and Obstetric Conditions) Study is the Largest U.S.-Based Prospective Study Demonstrating a Circulating Fetal Cell (CFC) Based Approach to Non-invasive Fetal Risk AssessmentNCT07643896 · Sponsor · RECRUITING
Response Adapted Neoadjuvant Therapy in Gastroesophageal Cancers (RANT-GC Trial)NCT05733689 · Sponsor · RECRUITING
Utility of ctDNA in Early Switch of First-line mFOLFIRINOX in Metastatic Pancreatic Ductal AdenocarcinomaNCT07096362 · Sponsor · RECRUITING
Regulatory
Regulatory records
No linked records are currently available.
04 · Company-reported outcomes
Outcomes and case studies
Company-reported outcomes and customer stories are distinct from linked Research Intelligence evidence.
3x more affected pregnancies identified
Unity Complete vs traditional prenatal screening
50%+ more clinically actionable alterations
Northstar Select vs other ctDNA tests
51% more SNV/Indels detected
Head-to-head comparison study
109% more CNVs detected
Compared to available comparators
45% fewer null reports
Northstar Select performance
0.01% tumor fraction detection
Northstar Response sensitivity
>99% accuracy
CH classification (>99% PPA, >99% NPA, n=114)
National Cancer Center Hospital East
Selection of Northstar Select as the liquid biopsy test for LC-SCRUM-TRY clinical study
Selected as the new liquid biopsy test for clinical study
05 · Leadership
Leadership team
Leadership profiles and professional links from the current Company record.
06 · Company updates
Updates from BillionToOne
Recent articles published on BillionToOne's official website.
07 · HAIC coverage
Coverage and analysis
Health AI Central reporting that mentions this Company.
No HAIC coverage is currently linked to this Company.
08 · Official presence
Company sources and channels
Curated official destinations from the active Company record.
09 · Market pathway
Additional Companies in this Market
Other active Companies in the same market, selected alphabetically from the HAIC directory.
Market context
Precision Medicine & Genomics
Companies using AI to analyze genomic, proteomic, metabolomic, or multi-omics data to provide personalized treatment recommendations, identify genetic risks, or develop targeted therapies. Includes genomic sequencing platforms with AI analysis, preventive medicine based on genetic risk assessment, and longevity care based on molecular and genetic data.
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Linked research, clinical, and regulatory source pathways.
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Record-level provenance and review context.