What Nucleix does

Nucleix (legal entity Nucleix Ltd.) is a privately held, venture-backed molecular diagnostics company founded in 2008, with global headquarters and R&D in Rehovot, Israel and a US commercial office in San Diego, California. The company develops, manufactures, and markets non-invasive liquid biopsy tests for cancer detection and monitoring, serving healthcare providers including urologists, hospitals, cancer centers, and laboratories. Its commercial flagship is Bladder EpiCheck, a urine-based test for monitoring non-muscle invasive bladder cancer (NMIBC) recurrence and detecting upper tract urothelial carcinoma; Lung EpiCheck, a blood-based early lung cancer detection test, is in development.

The products are built on the proprietary EpiCheck platform, a PCR-based epigenetics technology that analyzes DNA methylation patterns in blood or urine. The company reports the platform can detect a single cancer molecule in a background of 200,000 normal molecules, runs on standard lab equipment, and delivers same-day results with an objective numerical score (0–100). Biomarker panels are constructed using bioinformatics and machine learning algorithms applied to methylation data. Reported clinical performance for Bladder EpiCheck includes 91% sensitivity for high-grade cancers, 99% negative predictive value for high-grade cancer, and 84% specificity. The platform holds FDA 510(k) clearance (2023) and CE marking, with CLIA accreditation and ISO 13485:2016 certification supporting US and Israeli operations.

Nucleix monetizes through diagnostic test sales to healthcare providers, hospitals, and laboratories, combining a direct US sales organization targeting hospitals and urology clinics with distribution partnerships across Europe—principally A. Menarini Diagnostics, which covers 40+ countries. Pricing is quote-based and not publicly disclosed. Go-to-market relies heavily on clinical evidence generation: peer-reviewed publications (European Urology Oncology, Chest Journal), conference presentations (EAU, AUA, ESOU), educational webinars, and collaborations with leading medical centers such as Cleveland Clinic, Radboud UMC, Medical University of Vienna, and the University of Sheffield. The company raised approximately $77 million in total capital in 2021–2022 and is backed by investors including OrbiMed, RA Capital Management, Sands Capital, BlackRock, and Aurum Ventures.

Name

Nucleix

Legal name

Nucleix Ltd.

Website

https://nucleix.com

Company type

Private

Founded year

2008

Operating status

Operating

Headcount range

11–50 employees

Short description

Nucleix develops and markets non-invasive liquid biopsy cancer tests using its DNA methylation-based EpiCheck platform, selling Bladder EpiCheck (FDA-cleared, CE-marked) and developing Lung EpiCheck for urologists, hospitals, cancer centers, and laboratories across the US and Europe.

Ownership category

akta.pro rank

Product category

Cancer Molecular Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Medical Laboratories (621511)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Services-Medical Laboratories (8071)

akta.pro primary industry

Molecular Diagnostics (PCR/qPCR, NGS-based assays) (HLAAALAA)

akta.pro secondary industries

Molecular Diagnostics (PCR/NAAT/NGS-based IVD) (HLAHAAAD), Oncology Diagnostics (tumor profiling, MRD, liquid biopsy) (HLAAALAE), Lung Cancer Screening & Pulmonary Nodule Clinic (HLAKANAI)

Keywords

• Liquid biopsy diagnostics
• DNA methylation assays
• Cancer molecular diagnostics
• Bladder cancer monitoring
• Non-invasive cancer detection

Headquarters

HQ city

Rehovot

HQ country

Israel

HQ region

Middle East

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Supply Chain, Infrastructure

Revenue model

1. Diagnostic Test Sales: Nucleix develops, manufactures, and markets non-invasive cancer tests using its EpiCheck technology. Revenue is generated through the sale of Bladder EpiCheck diagnostic tests to healthcare providers, hospitals, and laboratories. The company has received FDA 510(k) clearance for Bladder EpiCheck in the US and CE marking for European distribution.
2. Distribution Partnerships: Revenue generated through strategic distribution partnerships such as with A. Menarini Diagnostics for commercialization and distribution of Bladder EpiCheck across Europe.

Pricing tiers

Go-to-market motion1 record

Distribution channels3 records

Marketing channels5 records

Core offering

Nucleix develops, manufactures, and markets non-invasive molecular diagnostic tests for cancer detection using its proprietary EpiCheck platform based on PCR-based epigenetics and DNA methylation analysis. The company sells Bladder EpiCheck, a urine-based test FDA 510(k) cleared for bladder cancer recurrence monitoring in the US and CE-marked in Europe, and is developing Lung EpiCheck, a blood-based test for early-stage lung cancer detection in high-risk individuals. Tests are sold to healthcare providers including hospitals, urology clinics, cancer centers, and laboratories.

Product overview

Nucleix offers a portfolio of non-invasive cancer detection tests built on the EpiCheck technology platform. The core product, Bladder EpiCheck (FDA 510(k) cleared and CE-marked), is a urine-based test for monitoring bladder cancer recurrence using DNA methylation analysis. Lung EpiCheck, currently in development, is a blood-based test for early lung cancer detection. Both products leverage the EpiCheck platform's ultra-sensitive PCR-based epigenetics technology that can detect extremely rare cancerous molecules with high accuracy and objective results.

Differentiator

Problem solved

Functional benefit

Brands

• Bladder EpiCheck: Urine-based test for detection and monitoring of bladder cancer and upper tract urothelial carcinoma. CE-marked for Europe, FDA 510(k) cleared for US.
• Lung EpiCheck
• EpiCheck

Products and services

• Bladder EpiCheck A non-invasive urine test that detects recurrence of bladder tumors by analyzing DNA methylation patterns. FDA 510(k) cleared for monitoring NMIBC recurrence in the United States and CE-marked for primary and recurrent bladder cancer and upper tract urothelial cancer in Europe. Demonstrates 91% sensitivity for high-grade cancers and 99% NPV. Sold to urologists, hospitals, cancer centers, and laboratories for bladder cancer surveillance.
• Lung EpiCheck A blood-based test in development that detects lung tumor DNA circulating in blood by identifying disease-specific DNA methylation markers. Intended for early-stage lung cancer detection in high-risk individuals as a population-wide screening approach. Targeted at healthcare systems, pulmonology departments, and lung cancer screening programs.

Quantifiable outcome

• 91% sensitivity for high-grade bladder cancers
• +4 more outcomes

Named customers6 records

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability2 records

Feature3 records

Partnerships

Eight partnerships are on record, tiered core and secondary.

• A. Menarini DiagnosticscoreChannel Partner/ Reseller/ Distributor · 1 September 2024Strategic partnership for commercialization and distribution of Bladder EpiCheck, a urine-based genomic test for early detection and monitoring of bladder and upper tract urothelial cancers across Europe. A. Menarini Diagnostics is a company bringing advanced solutions to the in vitro diagnostic market.
• Cleveland CliniccoreStrategic or Co-development PartnerClinical collaboration and validation studies for EpiCheck technology in bladder and lung cancer detection programs.
• Radboud UMCcoreStrategic or Co-development PartnerLeading medical center collaboration for clinical validation and real-world implementation of Bladder EpiCheck in NMIBC surveillance.
• Duke HospitalsecondaryStrategic or Co-development PartnerClinical collaboration for bladder cancer detection studies.
• University of WashingtonsecondaryStrategic or Co-development PartnerAcademic medical center partnership for clinical validation studies.
• Vanderbilt UniversitysecondaryStrategic or Co-development PartnerAcademic medical center partnership for clinical validation studies.
• Fundacio PuigvertsecondaryStrategic or Co-development PartnerEuropean medical center collaboration for bladder and upper tract urothelial carcinoma studies.
• AMC (Academic Medical Center)secondaryStrategic or Co-development PartnerAcademic medical center partnership for clinical studies.

Scale indicators4 records

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• Grail: Grail is a multi-cancer early detection (MCED) company developing the Galleri blood test. Highly comparable to Lung EpiCheck's intended use case, with overlapping methylation-based cfDNA technology, and is led by Nucleix's former CCO Michael Vicari.
• Hologic: Hologic is a major diagnostics company with strengths in molecular and women's health diagnostics (e.g., Panther system, Aptima assays). Comparable as a larger IVD player with PCR-based platforms serving clinical laboratories globally.
• Guardant Health: Guardant Health is a leading liquid biopsy company offering Guardant360 (tumor profiling) and Shield (CRC screening). Overlaps with Nucleix in oncology blood-based diagnostics but at a much larger commercial scale and broader cancer coverage.
• Exact Sciences: Exact Sciences develops Cologuard (CRC screening) and Oncotype DX (cancer treatment selection). Compares to Nucleix as a non-invasive molecular diagnostics company in cancer screening and detection, though at substantially greater scale.
• NeoGenomics: NeoGenomics operates a global oncology testing services network offering molecular, FISH, and IHC tests. Comparable to Nucleix as a cancer-focused diagnostics provider, though with a broader service-based model rather than a kit-based product.
• Cepheid (Danaher): Cepheid, a Danaher subsidiary, provides PCR-based molecular diagnostic platforms widely used in clinical labs. Its GeneXpert system is a competitor and complementary technology for running PCR-based oncology and infectious disease tests similar to EpiCheck.
• Natera: Natera is a leading oncology and reproductive health liquid biopsy company with products like Signatera (MRD) and Vantage. Comparable to Nucleix in its use of cell-free DNA analysis for cancer detection, though it operates at significantly larger scale and broader scope.
• bioMérieux: bioMérieux is a global in vitro diagnostics company with strong oncology and infectious disease offerings. Relevant peer because it acquired Astute Medical (co-founded by Nucleix CEO Chris Hibberd), demonstrating M&A interest in differentiated diagnostic assets.

Others

• Bio-Techne: Bio-Techne provides reagents, antibodies, and assay components used in molecular diagnostics and methylation-based assays. Adjacent to Nucleix as an enabling supplier of diagnostic reagents rather than a direct competitor.

Direct peers

• MDxHealth: MDxHealth is a direct peer offering molecular diagnostic tests for urological cancers, including SelectMDx (prostate) and ConfirmMDx, using methylation-based biomarker technology similar to Nucleix's EpiCheck platform.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/nucleix2
• Facebookfacebook.com/1505230556359710
• LinkedInlinkedin.com/company/nucleix-ltd-

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles11 records

Funding overview

Funding rounds5 records

Investors14 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Nucleix