Universal Diagnostics
Universal Diagnostics (Universal DX) is a clinical-stage Spanish biotechnology company developing blood-based multi-omics and machine learning tests for early cancer detection, with lead product Signal-C® for colorectal cancer screening. It pursues FDA approval and US distribution via an exclusive strategic collaboration with Quest Diagnostics.
- Company typePrivate
- Founded2012
- HeadquartersSevilla, Spain
- Headcount101–250
- GTM typeB2B
- OfferingHardware or Manufacturing
What Universal Diagnostics does
Universal Diagnostics, S.A. (operating as Universal DX) is a clinical-stage biotechnology company founded in 2012 and headquartered in Seville, Spain, with additional offices in Madrid, Ljubljana (Slovenia), and Dallas (Texas). The company develops minimally invasive, blood-based diagnostic tests (liquid biopsies) for the early detection of cancer and pre-cancerous lesions. Its core technology is a multi-omics platform that combines methylomics, fragmentomics, and microbiomics with proprietary computational biology and machine learning algorithms trained on cell-free DNA from patient blood samples. The lead product, Signal-C®, is a colorectal cancer and advanced adenoma screening test that has demonstrated 93% sensitivity and 92% specificity for colorectal cancer and 54% sensitivity for advanced adenomas at 92% specificity in clinical studies. The company is conducting an FDA pivotal validation study targeting more than 15,000 patients, with completion expected by mid-2025, and is extending the platform to additional cancer indications including pancreatic (Signal-P), liver (Signal-L), lung (Signal-LU), and gastric (Signal-G).
The business model is currently pre-commercial and centered on clinical validation and regulatory approval. Post-FDA approval, Universal DX plans to commercialize Signal-C in the United States through an exclusive strategic collaboration with Quest Diagnostics, leveraging its laboratory network to reach the average-risk screening population (ages 45-84). Revenue mechanics will follow a per-test diagnostic services model routed through Quest. The company has raised approximately $150 million+ in cumulative funding across 13+ rounds, with a $70 million Series B in November 2023 led by Quest Diagnostics, a Series B extension in August 2024 with Olympus Innovation Ventures, a €20.8 million European Investment Bank facility in February 2025, and a $34.9 million round from SETT in January 2026. Universal DX holds ISO 13485 certification for the development, manufacture, and distribution of multi-omic in-vitro diagnostic devices and operates a clinical network of more than 140 hospitals across 10 countries with more than 14,000 samples recruited.
Customers today are primarily clinical research partners (hospitals, biobanks, academic centers) contributing samples and validation data. The future paying customer base is healthcare providers, gastroenterologists, and integrated health systems ordering Signal-C for average-risk screening populations as an alternative to colonoscopy. Public-segment marketing is event-driven, centered on presentations at DDW, AACR, ASCO GI, ESMO, and EACR, plus peer-reviewed publications and earned media coverage. The company is led by co-founder and CEO Juan Martinez Barea, co-founder and CTO Marko Bitenc, and COO Christian Hense, supported by a 13-member scientific advisory board.
Universal Diagnostics firmographics
Firmographics- Name
- Universal Diagnostics
- Legal name
- Universal Diagnostics, S.A.
- Website
- https://universaldx.com
- Company type
- Private
- Founded year
- 2012
- Operating status
- Operating
- Headcount range
- 101–250 employees
- Short description
- Universal Diagnostics (Universal DX) is a clinical-stage Spanish biotechnology company developing blood-based multi-omics and machine learning tests for early cancer detection, with lead product Signal-C® for colorectal cancer screening. It pursues FDA approval and US distribution via an exclusive strategic collaboration with Quest Diagnostics.
- Ownership category
- akta.pro rank
Universal Diagnostics industry classification
Industry- Product category
- Cancer Diagnostics (Liquid Biopsy)
- NAICS
- In-Vitro Diagnostic Substance Manufacturing (325413), Medical Laboratories (621511), Research and Development in Biotechnology (except Nanobiotechnology) (541714)
- SIC
- In Vitro & In Vivo Diagnostic Substances (2835), Services-Medical Laboratories (8071)
- akta.pro primary industry
- Liquid Biopsy & Minimal Residual Disease (MRD) Precision Testing (HLAAANAG)
- akta.pro secondary industries
- Liquid Biopsy Biomarkers (ctDNA/ctRNA/CTCs/exosomes) (HLAAAMAH), Oncology Diagnostics (tumor profiling, MRD, liquid biopsy) (HLAAALAE), Molecular Diagnostics (PCR/NAAT/NGS-based IVD) (HLAHAAAD), Companion Diagnostics (CDx) & Therapy Selection Assays (HLAAALAF)
Keywords
Where Universal Diagnostics is headquartered
LocationHeadquarters
- HQ city
- Sevilla
- HQ country
- Spain
- HQ region
- Europe
Offices4 records
Markets served
Universal Diagnostics business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Operations, Marketing or Sales, Infrastructure
Revenue model
- Diagnostic Testing Services: Revenue will be generated through blood-based cancer screening tests (Signal-C® and future multi-cancer platform tests) distributed via the Quest Diagnostics laboratory network following FDA approval. The company is developing multiple cancer detection tests including Signal-C® (colorectal), Signal-P™ (pancreatic), Signal-L™ (liver), Signal-LU™ (lung), and Signal-G™ (gastric).
Go-to-market motion2 records
Distribution channels1 record
Marketing channels5 records
Universal Diagnostics product offering
Product offeringCore offering
Universal Diagnostics (Universal DX) develops minimally invasive, blood-based liquid biopsy tests for the early detection of cancer and pre-cancerous lesions. Its lead product, Signal-C®, analyzes cell-free DNA (cfDNA) using a proprietary multi-omics platform that combines methylomics, fragmentomics, and microbiomics with computational biology and machine learning to detect colorectal cancer and advanced adenomas. A pipeline of additional Signal tests targets pancreatic, liver, lung, and gastric cancers.
Product overview
Universal DX operates as a bioinformatics and multi-omics company developing a Cancer Platform—a set of minimally-invasive, blood-based solutions for early cancer detection. The core platform combines multi-omics analysis (methylomics, fragmentomics, microbiomics) with computational biology and machine learning. The lead product is Signal-C®, a liquid biopsy test for colorectal cancer and Advanced Adenomas detection. The platform is being extended with pipeline products including Signal-P™ (pancreatic), Signal-L™ (liver), Signal-LU™ (lung), and Signal-G™ (gastric) cancers. The company is conducting FDA validation studies for Signal-C® with over 15,000 patients and has established strategic collaboration with Quest Diagnostics for US commercialization.
Differentiator
Problem solved
Functional benefit
Brands
- Signal C: Liquid biopsy blood test for colorectal cancer and advanced adenomas detection with 92% sensitivity and 94% specificity
- Signal-P
- Signal-L
- Signal-LU
- Signal-G
Products and services
- Signal-C® A liquid biopsy blood test that detects colorectal cancer and advanced adenomas (pre-cancerous lesions) using cell-free DNA (cfDNA) methylation and fragmentation analysis, achieving 93% sensitivity and 92% specificity for colorectal cancer and 54% sensitivity for advanced adenomas. Targeted at average-risk adults aged 45-84 and healthcare providers for non-invasive colorectal cancer screening.
- Signal-P™ Blood-based test for pancreatic cancer detection using the multi-omics platform combining methylation, fragmentation, and microbiome analysis with machine learning. Currently in pipeline/proof-of-concept stage.
- Signal-L™ Blood-based test for liver cancer detection using the multi-omics platform combining methylation, fragmentation, and microbiome analysis with machine learning. Currently in pipeline/proof-of-concept stage.
- Signal-LU™ Blood-based test for lung cancer detection using blood-based methylation analysis combined with the multi-omics platform. Proof-of-concept data has been presented at scientific conferences.
- Signal-G™ Blood-based test for gastric/stomach cancer detection using the multi-omics platform combining methylation, fragmentation, and microbiome analysis with machine learning. Currently in pipeline/proof-of-concept stage.
Quantifiable outcome
- 93% sensitivity for colorectal cancer detection
- +3 more outcomes
Companies that use Universal Diagnostics
Customer profileNamed customers2 records
Segments3 records
Ideal customer profiles2 records
Universal Diagnostics technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
AI capability4 records
Feature4 records
Universal Diagnostics partnerships and signals
Strategic signalPartnerships
Two partnerships are on record, tiered core.
- Hologic (Diagenode)coreR&D partner for technology development. Hologic (through Diagenode) is a world-class R&D partner supporting Universal DX\'s multi-omics platform development and cancer detection technology.
- Singularity UniversitycoreCompany was founded on Silicon Valley\'s ideals of technology and development originating from Singularity University, which influenced the company\'s approach to innovation and technology development.
Scale indicators6 records
Recent moves6 records
Expansion highlights6 records
Universal Diagnostics competitors and assessment
Company assessmentMarket position
Competitive moat6 records
Key risks6 records
Key highlights7 records
Customer concentration
Universal Diagnostics social profiles
Digital presenceUniversal Diagnostics compliance and trust
Trust signalCompliance1 record
Universal Diagnostics financial estimates
Financial estimateRevenue estimate
Valuation estimate
Universal Diagnostics leadership team
Management profileNumber of profiles
Profiles3 records
Universal Diagnostics subsidiaries and ownership
Company hierarchySubsidiaries2 records
Universal Diagnostics funding detail
Funding detailFunding overview
Funding rounds13 records
Investors7 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Universal Diagnostics 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 Universal Diagnostics
What does Universal Diagnostics do?
Universal Diagnostics (Universal DX) develops minimally invasive, blood-based liquid biopsy tests for the early detection of cancer and pre-cancerous lesions. Its lead product, Signal-C®, analyzes cell-free DNA (cfDNA) using a proprietary multi-omics platform that combines methylomics, fragmentomics, and microbiomics with computational biology and machine learning to detect colorectal cancer and advanced adenomas. A pipeline of additional Signal tests targets pancreatic, liver, lung, and gastric cancers.
Is Universal Diagnostics a public or private company?
Universal Diagnostics is a private company. It is classified as venture growth investor backed and is currently operating.
When was Universal Diagnostics founded?
Universal Diagnostics was founded in 2012. It employs 101 to 250 people.
Where is Universal Diagnostics based?
Universal Diagnostics is headquartered in Sevilla, Spain, in the Europe region.
How does Universal Diagnostics make money?
One revenue line is on record: diagnostic Testing Services.
Does Universal Diagnostics have an API?
No public API is recorded for Universal Diagnostics.
What industry is Universal Diagnostics in?
Universal Diagnostics's product category is Cancer Diagnostics (Liquid Biopsy). Its primary akta.pro industry code is HLAAANAG, Liquid Biopsy & Minimal Residual Disease (MRD) Precision Testing, with a secondary code of HLAAAMAH, Liquid Biopsy Biomarkers (ctDNA/ctRNA/CTCs/exosomes). Its NAICS code is 325413 and its SIC code is 2835.