PreciseDx
PreciseDx is a private AI-powered oncology diagnostics company whose PreciseBreast test analyzes standard H&E pathology slides to predict breast cancer recurrence risk in hours. It serves oncologists, surgeons, pathologists, payors, and patients ahead of a planned 2026 commercial launch.
- Company typePrivate
- Founded2021
- HeadquartersNew York, United States
- Headcount1–10
- GTM typeB2B
- OfferingServices
What PreciseDx does
PreciseDx is a privately held, venture-backed oncology diagnostics company founded in 2021 (per company timeline) and headquartered in New York City, with a secondary CLIA-certified laboratory in Coral Gables, Florida. The company develops and commercializes AI-powered digital pathology tests that analyze standard hematoxylin and eosin (H&E)-stained biopsy slides already produced in routine pathology workflows. Its flagship product, PreciseBreast, uses the proprietary OncoIntelligence platform and Morphology Feature Array (MFA) technology to extract AI-derived morphologic features from breast cancer tissue and combine them with four clinical factors (age, tumor size, anatomic stage, lymph node status) to produce a single OncoIntelligence Score between 0 and 100 that stratifies patients by recurrence risk. The technology has been clinically validated in over 3,000 breast cancer cases across multiple independent cohorts (Mount Sinai, Baptist Health Miami Cancer Institute with COTA real-world data, Netherlands Dordrecht Albert Schweitzer Hospital against MammaPrint, and prospective Lankenau / Main Line Health data), with reported performance metrics of 94% negative predictive value, 98% tumor segmentation precision, less than 2% assay risk score variation, and 99% intra-lab concordance.
The company generates revenue on a per-test basis through its CLIA-certified and CAP-accredited laboratories, with PreciseBreast priced at approximately 30% the cost of gene expression testing (which exceeds $4,000). The test is billed using AMA CPT PLA code 0220U and is available in all 50 US states. Customer segments include oncologists, breast surgeons, and pathologists (who order the test), payors and health insurers (who reimburse it), and breast cancer patients (who benefit from faster turnaround, results in hours versus 2–6 weeks for gene expression tests). An Early Access Program was initiated in 2024 ahead of a planned full commercial launch in 2026. PreciseDx has raised over $43 million across a $10.75M Series A (January 2022), a $20.7M Series B (August 2024), and an $11M follow-on round (June 2025), with strategic institutional investors including Eventide Asset Management, Merck Global Health Innovation Fund, Philips Ventures, Labcorp, Quest Diagnostics, and GenHenn Capital Venture.
The go-to-market is enterprise field sales targeting oncology clinical teams at major US health systems, supported by a web-based ordering portal (portal.precisedx.ai), a dedicated medical affairs team, peer-reviewed publications, and presence at major conferences (SABCS, ASCO, EBCC, USCAP). The commercial team is led by a VP of Commercial Development and a VP of Global Market Access responsible for payor coverage. A Scientific Advisory Board comprising six internationally recognized breast cancer experts was formed in November 2024 to support clinical positioning and product portfolio expansion.
PreciseDx firmographics
Firmographics- Name
- PreciseDx
- Legal name
- PreciseDx Inc.
- Website
- https://precisedx.ai
- Company type
- Private
- Founded year
- 2021
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- PreciseDx is a private AI-powered oncology diagnostics company whose PreciseBreast test analyzes standard H&E pathology slides to predict breast cancer recurrence risk in hours. It serves oncologists, surgeons, pathologists, payors, and patients ahead of a planned 2026 commercial launch.
- Ownership category
- akta.pro rank
PreciseDx industry classification
Industry- Product category
- Oncology Diagnostics
- NAICS
- Medical Laboratories (621511)
- SIC
- Services-Medical Laboratories (8071)
- akta.pro primary industry
- Laboratory Developed Tests (LDTs) & Specialized Clinical Lab Assays (HLAAALAN)
- akta.pro secondary industries
- Oncology Diagnostics (tumor profiling, MRD, liquid biopsy) (HLAAALAE), Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays) (HLAAAMAC)
Keywords
Where PreciseDx is headquartered
LocationHeadquarters
- HQ city
- New York
- HQ country
- United States
- HQ region
- North America
Offices2 records
Markets served
PreciseDx business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Technology or R&D, Marketing or Sales, Operations, Infrastructure
Revenue model
- Laboratory Diagnostic Testing (PreciseBreast): PreciseDx operates CLIA-certified laboratories in New York and Miami providing PreciseBreast diagnostic testing services. Revenue is generated on a per-test basis for breast cancer recurrence risk assessment. Testing is ordered by physicians and healthcare professionals, billed to patients or their health insurers. The company offers patient billing, payment plans, interest-free payment options up to 6 months, and a Patient Assistance Program for those who qualify. CPT code 0220U.
- Future Pipeline - Other Solid Tumor Types: CEO indicated OncoIntelligence platform can provide treatment guidance for many other solid tumor types beyond breast cancer, suggesting future expansion of diagnostic testing services across oncology.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Unit Pricing | Pay-as-you-go | PreciseBreast Test - Laboratory Diagnostic Service |
Go-to-market motion3 records
Distribution channels3 records
Marketing channels7 records
PreciseDx product offering
Product offeringCore offering
PreciseDx provides AI-powered laboratory diagnostic testing through its flagship PreciseBreast test, which analyzes standard H&E-stained pathology slides using the proprietary OncoIntelligence platform to deliver objective breast cancer recurrence risk scores to oncologists, surgeons, and pathologists. The company operates CLIA-certified labs in New York and Miami, processing tests ordered via an online portal and reimbursed through health insurers using CPT code 0220U, with results delivered in hours at approximately 30% of the cost of gene expression testing.
Product overview
PreciseDx offers a single unified product, PreciseBreast, powered by its proprietary OncoIntelligence AI-platform. PreciseBreast is an AI-digital pathology test that analyzes standard H&E-stained breast cancer biopsy slides to predict recurrence risk, producing an OncoIntelligence Score that stratifies patients into risk cohorts within hours—significantly faster and less expensive than traditional gene expression testing. The platform combines Morphology Feature Array (MFA) technology with clinical factors to deliver objective, quantifiable risk assessment.
Differentiator
Problem solved
Functional benefit
Brands
- OncoIntelligence™: Proprietary AI platform that combines AI-grade features with clinical factors to produce an OncoIntelligence Score for cancer risk assessment.
- PreciseBreast®
- Morphology Feature Array® (MFA)
Products and services
- PreciseBreast AI-powered laboratory-developed breast cancer recurrence risk assessment test that analyzes H&E-stained pathology slide images combined with clinical factors (age, tumor size, anatomic stage, lymph node status) using the OncoIntelligence platform. Produces an OncoIntelligence Score (0-100) stratifying patients into low and high risk cohorts, delivered to oncologists, surgeons, and pathologists in hours rather than weeks, at approximately 30% the cost of gene expression testing. Validated in more than 3,000 breast cancer cases.
Quantifiable outcome
- 94% Negative Predictive Value; <2% variation in assay risk score; 98% precision in tumor segmentation; 99% intra-lab concordance
- +6 more outcomes
Companies that use PreciseDx
Customer profileNamed customers6 records
Segments5 records
Ideal customer profiles2 records
PreciseDx technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
AI capability4 records
Feature5 records
PreciseDx partnerships and signals
Strategic signalPartnerships
Twelve partnerships are on record, tiered minor and core.
- Kyowa KirinminorSenior leader from Kyowa Kirin participated in NYC Leadership Summit panel moderated by PreciseDx's VP of AI & Technology Vijay Yadav, discussing AI's role in drug discovery and balance between regulation and innovation.
- Memorial Sloan Kettering Cancer CenterminorSenior leader from Memorial Sloan Kettering participated in NYC Leadership Summit panel moderated by PreciseDx's VP of AI & Technology, on AI's role in drug discovery and precision medicine.
- AstraZenecaminorSenior leader from AstraZeneca participated in NYC Leadership Summit panel moderated by PreciseDx's VP of AI & Technology, on AI's role in drug discovery.
- Lankenau Medical Center / Main Line HealthcoreLankenau presented prospective evaluation of PreciseBreast AI tool in early-stage invasive breast cancer risk stratification at 2025 SABCS, independently validating the technology in a real-world clinical setting for HR+, HER2- early breast cancer patients.
- National Comprehensive Cancer Network (NCCN)coreNCCN is listed as a key medical society partner. NCCN represents leading academic cancer centers working to improve quality, effectiveness, and efficiency of oncology care. Partnership supports PreciseDx's clinical credibility and guideline integration strategy.
- Baptist Health South Florida (Miami Cancer Institute)coreClinical collaboration to assess and validate PreciseBreast performance using real-world data curated by COTA. Baptist Health aims to offer AI-enabled testing to patients with invasive breast cancer, with goal of expanding access to innovations in cancer care. Benefits include results in 48 hours and 80% reduction in cost.
- COTA, Inc.coreCOTA (Founded by oncologists) provides curated real-world oncology data to validate PreciseBreast performance against traditional pathology reviews and 21-gene assay results. COTA's data abstraction methods analyze complex patient data to compare PreciseBreast to Oncotype DX and standard pathology.
- UCLAcoreCollaboration to advance AI-enabled predictions and risk mitigation for triple-negative breast cancer recurrence. UCLA researchers presented TNBC phenotyping findings at 2025 SABCS using PreciseBreast's AI digital pathology approach to assess recurrence risk and response to therapy.
- Mount Sinai Health SystemcoreMount Sinai is the founding institution of PreciseDx. Dr. Carlos Cordon-Cardo, founder, is Professor and System Chair of Pathology at Mount Sinai. Mount Sinai cohort was used for initial validation published in Breast Cancer Research 2022. Dr. Erik Lium serves on PreciseDx's board.
- NSABP (National Surgical Adjuvant Breast and Bowel Project)minorCompany mentioned collaboration with NSABP to further evaluate PreciseBreast's ability to predict chemotherapy benefit in early-stage breast cancer population.
- SharsheretminorSharsheret is a national nonprofit organization supporting Jewish women with breast cancer. Listed as a key medical society partner on the company website.
- Florida Society of Clinical OncologyminorListed as a key medical society partner on the company website, supporting professional education and awareness in Florida.
Scale indicators5 records
Recent moves6 records
Expansion highlights7 records
PreciseDx competitors and assessment
Company assessmentDirect peers
- Paige.AI: Paige builds AI-enabled digital pathology solutions for cancer diagnosis and prognosis across multiple tumor types. Both Paige and PreciseDx apply AI to H&E pathology images to support oncology decision-making, sharing the AI pathology category and pathology customer base.
- PathAI: PathAI provides AI-powered pathology solutions for diagnostics and biopharma research. Both companies operate AI digital pathology platforms serving oncologists and pathologists with image-based diagnostic and prognostic analytics.
- Exact Sciences: Exact Sciences markets Oncotype DX, the dominant 21-gene expression test for breast cancer recurrence risk. PreciseBreast is positioned as a faster, cheaper, AI-enabled alternative using H&E slides, making Exact Sciences the most directly comparable competitor in the same indication and customer base.
- Owkin: Owkin applies AI to pathology and clinical data for oncology drug development and diagnostics. Both companies leverage AI on H&E images to deliver prognostic insights for cancer patients, addressing biopharma and clinical oncology customers.
- Ibex Medical Analytics: Ibex deploys AI-powered pathology solutions for cancer detection and grading across multiple tissue types. Both companies operate in AI-driven cancer pathology with the same clinical customer base (pathologists, oncologists) and overlapping technology approach.
Broad incumbents
- Tempus Labs: Tempus is an AI-driven precision medicine company offering multimodal diagnostics including pathology, genomics, and clinical data for oncology. Both companies apply AI to oncology decision-making, though Tempus operates at broader scale and across multiple diagnostic modalities.
- Caris Life Sciences: Caris Life Sciences offers molecular profiling and AI-driven oncology diagnostics including MI Profile and Caris Assure. Both companies target oncologists with advanced diagnostics that combine molecular and AI-based insights for treatment planning.
- Veracyte: Veracyte is an established genomic diagnostics company with multiple oncology tests including the Prosigna breast cancer assay. Both companies serve oncologists with molecular/AI-driven cancer diagnostics, though Veracyte operates across a broader oncology portfolio.
- Foundation Medicine (Roche): Foundation Medicine is a leading molecular profiling company for oncology, part of Roche. Both companies serve oncologists with advanced cancer diagnostics for treatment planning, though Foundation Medicine focuses on comprehensive genomic profiling rather than morphology-based risk assessment.
- Guardant Health: Guardant Health is a leading precision oncology company offering liquid biopsy and genomic profiling tests for cancer patients. Both companies serve oncology customers with advanced diagnostics, though Guardant focuses on blood-based liquid biopsy rather than tissue morphology.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat6 records
Key risks7 records
Key highlights7 records
Customer concentration
PreciseDx social profiles
Digital presencePreciseDx compliance and trust
Trust signalCompliance5 records
PreciseDx financial estimates
Financial estimateRevenue estimate
Valuation estimate
PreciseDx leadership team
Management profileNumber of profiles
Profiles11 records
PreciseDx funding detail
Funding detailFunding overview
Funding rounds3 records
Investors9 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
PreciseDx 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 PreciseDx
What does PreciseDx do?
PreciseDx provides AI-powered laboratory diagnostic testing through its flagship PreciseBreast test, which analyzes standard H&E-stained pathology slides using the proprietary OncoIntelligence platform to deliver objective breast cancer recurrence risk scores to oncologists, surgeons, and pathologists. The company operates CLIA-certified labs in New York and Miami, processing tests ordered via an online portal and reimbursed through health insurers using CPT code 0220U, with results delivered in hours at approximately 30% of the cost of gene expression testing.
Is PreciseDx a public or private company?
PreciseDx is a private company. It is classified as venture growth investor backed and is currently operating.
When was PreciseDx founded?
PreciseDx was founded in 2021. It employs 1 to 10 people.
Where is PreciseDx based?
PreciseDx is headquartered in New York, United States, in the North America region.
How does PreciseDx make money?
Two revenue lines are on record. Laboratory Diagnostic Testing (PreciseBreast) is the primary driver. The others are future Pipeline - Other Solid Tumor Types.
Who are PreciseDx's main competitors?
Direct peers on record are Paige.AI, PathAI, Exact Sciences, Owkin and Ibex Medical Analytics. Broad incumbents are Tempus Labs, Caris Life Sciences, Veracyte, Foundation Medicine (Roche) and Guardant Health.
Does PreciseDx have an API?
No public API is recorded for PreciseDx.
What industry is PreciseDx in?
PreciseDx's product category is Oncology Diagnostics. Its primary akta.pro industry code is HLAAALAN, Laboratory Developed Tests (LDTs) & Specialized Clinical Lab Assays, with a secondary code of HLAAALAE, Oncology Diagnostics (tumor profiling, MRD, liquid biopsy). Its NAICS code is 621511 and its SIC code is 8071.