The Universal DX Story: AI-Powered Cancer Detection from a Single Drop of Blood

Universal DX is a biotechnology company from Seville (Spain) that dared to take on the mission of detecting cancer early through a simple blood sample. Born from the bold and sustained vision of two entrepreneurs, a business visionary and a biotech genius, they have developed a technology capable of catching cancer before it advances. This is the story of how an apparently impossible idea has become one of the most promising ventures in modern medicine. Let us explore the story of Universal DX.

Detecting cancer before it is too late remains one of medical science’s greatest challenges. Millions of people die each year due to late-stage diagnoses, particularly in silent-onset tumors like colorectal cancer, which can develop undetected for years. Solving this problem is not only about saving lives; it is about fundamentally transforming public healthcare systems worldwide.

Yet, behind such a highly sought-after solution lies immense complexity. Developing a tool capable of identifying faint cancer signals in blood requires bridging vastly different disciplines, including genomics, artificial intelligence, molecular biology, and biostatistics. It is a high-stakes challenge with virtually zero margin for error, where scientific validation demands years of rigorous clinical trials.

Beyond the technological hurdles, Universal DX had to navigate an uncertain business landscape. The team needed continuous capital injection while simultaneously building credibility, establishing global strategic partnerships, and attracting international talent. Step by step, the company overcame every obstacle through sheer determination and clarity of purpose.

This narrative goes beyond science or business; it is a case study in vision, persistence, and courage, demonstrating how an improbable idea gained traction to reshape the future of early cancer detection. Join us in discovering how Juan Martínez Barea and Marko Bitenc joined forces to create Universal DX: a company that is not just developing technology, but actively turning cancer into a curable disease through early detection.

Universal DX’s Mission: Making Cancer Curable

Juan Martínez-Barea: The Visionary

Juan Martínez-Barea was born in Seville (Spain) into a humble family originating from Macael, a town in Almería known for its marble quarries. He earned his degree in Industrial Engineering from the University of Seville (1984–1990) and later completed a Master’s degree in Economics at the École Centrale in Paris, France, supported by an Erasmus scholarship (1990–1991). Following his studies, his parents hoped he would secure a position at a major corporation that could guarantee a stable, steady paycheck.

Juan, however, held a distinctly different vision for his professional career. Recognizing the need to broaden his global outlook, he set his sights on pursuing an MBA abroad. Reflecting on those early years, he noted: “My family couldn’t afford it, so I spent four years working and saving. While my friends were buying apartments and cars, I was saving every penny to cover my first year’s tuition”. Ultimately, he earned his MBA from the Massachusetts Institute of Technology (MIT) in the United States (1996–1998). Years later, in 2010, he also attended the Exponential Technologies Program at Singularity University, located at the NASA Ames Research Park in Moffett Field, California, an intensive program focused on disruptive technologies and their practical applications.

Without a doubt, Juan’s family instilled in him a work ethic centered on sacrifice and drive, which deeply shaped his entrepreneurial mindset. Prior to founding Universal DX, Martínez-Barea built a track record across global industry leaders, including the engineering multinational Abengoa and top-tier management consultancy McKinsey & Company. On the entrepreneurial front, he launched Creara in 1999, Spain’s very first tech startup accelerator, and, in partnership with MIT, spearheaded the 50K Competition, the pioneering startup competition in Southern Europe.

Marko Bitenc: The Biotech Genius

Marko Bitenc was born in Maribor, Slovenia. He studied biotechnology at the University of Ljubljana (Slovenia) and later completed a Master’s degree in Cellular and Molecular Biotechnology at Wageningen University in the Netherlands (2007–2010). Like Martínez-Barea, Bitenc also attended Singularity University, specifically participating in the flagship Global Solutions Program (GSP-10). This program focuses on leveraging disruptive technologies to address complex global challenges that typically carry a low initial probability of success.

Bitenc was already a successful entrepreneur before meeting Martínez-Barea. In 2008, he founded GenePlanet, a company where he still serves as CEO, specializing in lifestyle and diagnostic genetic testing. His career highlights include prestigious international accolades, such as winning first place in the Health & Medicine category at the 2007 MIT International Genetically Engineered Machine (iGEM) competition for a novel synthetic biology approach targeting the HIV-1 virus (virotrap).

Juan Martínez-Barea and Marko Bitenc met at Singularity University in 2010. Established in 2008 by NASA and Google, the academic institution was founded with a mission to assemble top global talent to solve humanity’s greatest challenges. As Juan recalls: “When the program ended, Marko Bitenc and I decided to tackle one of humanity’s biggest problems: cancer”.

Company Incorporation: Universal DX

Driven by Singularity University’s core ethos of addressing humanity’s greatest challenges, the co-founders identified cancer care as their target domain. Their core motivating premise was clear: “Cancer is a deadly disease primarily because it is detected too late. Conversely, 90% of early-stage cancer cases are curable”. Juan expanded on this rationale: “That is why we decided to focus on developing a simple, non-invasive, and reliable test for early cancer detection. Early detection can save more lives than the entire pharmaceutical industry combined”.

With a well-defined mission, developing an early cancer detection assay, Universal DX (also known as Universal Diagnostics or UDX) was officially incorporated in 2012 in Seville (Spain) by Juan Martínez-Barea and Marko Bitenc. Operating initially without a commercialized product or service, the company relied on its technical expertise and a single-minded determination to engineer a streamlined, highly efficient diagnostic workflow. Early on, the startup established its headquarters at the University of Seville’s Center for Research, Technology, and Innovation (CITIUS), leveraging the academic ecosystem and existing research infrastructure.

From the outset, the co-founders focused on building a proprietary technology platform designed to detect multiple cancer types through a single blood draw. While they prioritized colorectal cancer for their initial proof of concept, the long-term strategy envisioned expanding across additional oncology indications. As Juan noted: “Our goal is to target multiple cancer types, but we must do so sequentially: once our first assay is market-ready, we will roll out the second, targeting another high-impact cancer type”.

Project Complexity

Bringing any drug or medical product to market is an expensive, lengthy, complex, and highly regulated process. Efficacy alone is not enough: prior to commercialization, it must demonstrate safety, performance, and guaranteed quality control. These strict requirements make the development cycle long and capital-intensive, typically requiring between 10 and 15 years for product engineering and regulatory clearance.

This is fundamentally different from a standard consumer product or service that can be developed in weeks and launched almost immediately. It describes a deep-tech enterprise requiring tens of millions of dollars to recruit highly specialized researchers and secure advanced resources. Furthermore, early investors must commit capital based on long-term potential, accepting external risks that could impact market dynamics before commercialization, such as emerging competitors or shifting regulatory frameworks.

Consequently, the defining metric of success for a biotech startup of this nature is its fundraising capability. Plain and simple. It is a long-distance endurance race: if capital injections stall halfway through, the venture fails, rendering all prior effort obsolete.

Any therapeutic or diagnostic assay requires clearance from health authorities, such as the FDA (Food and Drug Administration) in the United States or the EMA (European Medicines Agency) in Europe. While drug approvals are historically arduous, Universal DX’s liquid biopsy test is non-invasive, requiring only a standard blood draw, making its regulatory pathway relatively streamlined by comparison. For instance, testing for toxicological side effects is unnecessary.

Although the timeline, cost, and commercial complexity of a diagnostic test are significantly lower than those of a therapeutic drug, the venture still demands nearly a decade of product R&D, roughly two years to secure regulatory authorizations, and robust global commercial partnerships to scale manufacturing and distribution.

Universal DX Laboratory in Seville (Spain)

The Early Years

Founder confidence and technical capability mean very little without capital; without financial runway, there is zero chance to prove a product’s viability. Consequently, Universal DX had to navigate two parallel strategic challenges:

The Scientific Challenge: Engineering an efficient, high-performance diagnostic platform that achieves broad validation within the oncology sector.
The Financial Challenge: Securing multi-year capital injections to sustain heavy R&D operations prior to generating commercial revenue.

While the scientific hurdle was immense, the financial challenge presented the steepest barrier to entry. Traditional venture capital investors typically demand returns within a three- to four-year horizon, if not sooner. Securing equity funding or debt financing for deep-tech biology ventures, no matter how compelling the pitch, is notoriously difficult. The addressable investor base is largely restricted to mission-driven, socially impact-focused investors and institutional funds.

The most precarious phase was the pre-seed stage, when the asset base consisted entirely of conceptual frameworks. Fortunately, the co-founders backed the project with their own capital and successfully closed an initial seed round, raising an estimated €2 million to €3 million. This capital launchpad enabled the company to build its core technology platform and recruit its initial team of scientific researchers.

In 2017, Universal DX executed its first major funding milestone in partnership with Adepa Asset Management. Adepa structured a dedicated investment vehicle, Universal Dx S.C.A. SICAV-RAIF, specifically designed to fund Universal DX’s growth. A SICAV-RAIF combines the corporate structure of an open-ended investment company (SICAV) with the regulatory framework of a Reserved Alternative Investment Fund (RAIF). Under Luxembourg law, the RAIF regime bypassed the requirement for prior authorization from the CSSF (Financial Sector Supervisory Commission), significantly accelerating time-to-capital.

This Series A alternative structure successfully raised €10 million from approximately 40 minority investors alongside the Regional Government of Andalusia (Junta de Andalucía). The Andalusian government contributed via a €3 million concessionary loan under the JEREMIE program (Joint European Resources for Micro to Medium Enterprises), an initiative engineered to support high-growth SMEs lacking access to traditional commercial banking debt.

This capital injection served as a critical inflection point, allowing Universal DX to scale its scientific and technical teams, accelerate the development of its proprietary biomarker platform, and generate its first validated clinical dataset.

Entry of Strategic Investors

The progress achieved was critical because it gave the team tangible clinical assets to present to potential backers. Yet, the company required continuous capital runway to stay afloat, much like riding a bicycle, where momentum is the only thing keeping you upright. In 2018, Universal DX secured a major vote of confidence: Enrique de Leyva, co-founder of the private equity firm Magnum Capital in 2006 alongside Ángel Corcóstegui, made a substantial private investment, acquiring approximately 5% of the company. De Leyva’s contribution, paired with investments from other business angels, injected another €7 million into Universal DX.

Following the investment, Enrique de Leyva joined the board as an independent director. Having served as Managing Partner of McKinsey & Company in Spain for 20 years, his appointment brought immense strategic weight alongside the financial backing. At that stage, Universal DX envisioned that de Leyva’s expertise would help prepare the company for an eventual initial public offering (IPO).

As Juan stated: “We invited Enrique to join our board because of his vast professional experience, talent, and business vision. We are confident that, as a director, he will add immense value to our company’s future growth”. The immediate roadmap was clear: finalize the commercial development of their blood-based cancer detection assay and subsequently execute an IPO to fund their global scaling strategy.

In 2020, Adepa structured a new financing round, securing €14 million. This round was subscribed by existing shareholders and supplemented by public funding mechanisms, including Horizon 2020, ENISA, and JEREMIE funds, which together contributed €5 million. This capital injection allowed Universal DX to finalize the clinical validation of its lead product, Signal-C®, and lay the groundwork for commercial readiness. In fact, investor appetite surged during the COVID-19 pandemic, driven by a heightened global focus on healthtech, diagnostic platforms, and biotechnology.

Universal DX Growth Trajectory (Data aggregated from various online sources)

The Quest Diagnostics Strategic Alliance

Published performance metrics for Signal-C®, the company’s non-invasive colorectal cancer screening assay, were highly promising, demonstrating a sensitivity of 93% and a specificity of 92%. Sensitivity reflects the test’s ability to correctly identify individuals who have colorectal cancer (accurately detecting 93 out of 100 positive cases). Specificity measures the test’s ability to yield a true negative for disease-free individuals (correctly classifying 92 out of 100 healthy subjects as cancer-free).

In November 2023, Universal DX announced a strategic partnership with Quest Diagnostics, the premier provider of diagnostic information services in the United States. Quest operates a network of 7,300 patient service centers, employs over 50,000 professionals, and reaches 50% of U.S. physicians and hospitals alongside 90% of insured individuals nationwide. Under the agreement, Quest established a dedicated central laboratory for Universal DX at its flagship facility in Lewisville, Texas, to manage all U.S. clinical trial operations and future processing.

The remaining milestone prior to full U.S. commercial roll-out is Premarket Approval (PMA) from the U.S. Food and Drug Administration (FDA). In January 2024, the companies initiated this regulatory pathway. Reflecting the scale and rigor of the process, the pivotal clinical trial required recruiting over 15,000 participants across 100 clinical sites to validate test performance. Upon securing FDA approval, Quest will leverage its national commercial network to distribute Signal-C® across the U.S. market.

Throughout 2023, Universal DX closed a record-setting Series B financing round supported by Quest Diagnostics, CDTI Innovación’s Innvierte program (co-investing alongside an Adepa Asset Management RAIF vehicle), and several leading Spanish family offices. The round achieved a first closing of €51 million in October, followed by a second closing of €34 million in December, totaling €85 million. This transaction represented the largest private financing round for a diagnostic technology startup in Spain, elevating Universal DX to “soonicorn” status.

With the U.S. regulatory submission underway for Signal-C®, the operational focus transitioned to clinical follow-up while awaiting FDA clearance to launch commercialization.

Strategic Alliance: Universal DX and Quest Diagnostics

It was time to pivot focus toward expanding the pipeline. In 2025, the European Investment Bank (EIB) granted Universal DX a €20 million venture debt facility. The capital allocation was designed to accelerate R&D and clinical pipelines for Signal-Li® (liver cancer) and Signal-Lu® (lung cancer), while supporting the ongoing FDA clinical trials. Backed by the InvestEU program, this financing reflects the EIB’s mandate to support European healthtech startups pioneering advanced solutions, innovation, and digital transformation.

Alessandro Izzo, EIB Director for Equity, Growth Capital, and Project Finance, noted: “We are delighted to join forces with Universal DX to advance the fight against cancer, specifically in early detection to improve patient survival rates. This financing agreement exemplifies the EIB’s commitment to supporting innovative European tech companies developing breakthrough medical solutions and fostering the European healthtech sector”.

The Scientific Challenge

Early cancer detection remains a critical pillar in driving curative outcomes. In its initial stages, cancer is typically localized and has not metastasized to distant organs, making surgical resection or targeted treatment significantly more effective. For several malignancies, including breast, colorectal, and prostate cancer, five-year survival rates exceed 90% when diagnosed early.

Today, standard-of-care screening protocols target specific high-risk demographics, defined primarily by age and biological sex. The most prevalent screening modalities include mammography, colonoscopy, and fecal immunochemical tests (FIT).

However, adherence rates to many conventional screening programs remain suboptimal due to patient discomfort, invasiveness, and complexity. An exception is the fecal occult blood test, which is simple, accessible, and demonstrates a reasonable sensitivity rate (~70%) for colorectal cancer detection. Nevertheless, non-malignant conditions such as hemorrhoids, anal fissures, or benign polyps frequently yield false-positive results.

Universal DX’s core thesis centers on non-invasive early cancer detection via a routine liquid biopsy. The paradigm shift envisions screening for early-stage malignancy as seamlessly as monitoring cholesterol levels during a routine checkup. As tumors initiate and progress, neoplastic cells shed circulating biomarkers into the bloodstream, even at stage I. Identifying these low-abundance molecular signals enables early diagnosis. Furthermore, because different organ-specific tumors shed distinct biomarker profiles, targeted blood analysis can pinpoint the specific tissue of origin. Consequently, the technology platform is inherently multi-cancer by design.

The primary scientific hurdle for Universal DX was evaluating advanced multi-omics technologies to isolate and validate circulating trace signals specific to various malignancies. The platform’s proof of concept prioritized colorectal cancer (Signal-C®). Following its completion in 2023, the pivotal clinical trial for FDA premarket approval was launched in January 2024. The pipeline has since expanded to address liver cancer (Signal-Li®) and lung cancer (Signal-Lu®). Leveraging established methodology and expanded capital resources, development timelines for these secondary indications are expected to compress significantly.

Additionally, the company has released preliminary data targeting pancreatic and esophageal cancers, demonstrating the broad scalability of its underlying multi-omics and AI platform.

Scientific Advisory Board of Universal DX

Their Technological Solution

Universal DX developed an innovative technology platform leveraging epigenetics, the study of changes in gene activity that occur without altering the underlying DNA sequence. In essence, while the genetic “text” remains constant, external variables such as environment, diet, stress, or age can switch specific genes on or off.

To identify early cancer indicators, the company deployed machine learning frameworks and advanced artificial intelligence (AI) algorithms. By training these models on thousands of patient samples, the system identifies distinct biomarker patterns associated with early-stage disease. Once validated, the engineering team designs targeted blood tests capable of isolating these signals. This workflow utilizes Next-Generation Sequencing (NGS) analytical frameworks, often referred to in clinical oncology as a liquid biopsy.

The company summarizes its proprietary technology platform as measuring proprietary microbiome, methylation, and fragmentation biomarkers. The system detects pattern signals across its biomarker panel by leveraging state-of-the-art bioinformatics tools and machine-learning-driven algorithms.

Project Status

Over time, Universal DX not only secured financial backing but also consolidated its clinical trials and expanded its international footprint. This enabled the company to assemble a world-class Scientific Advisory Board to connect directly with the global medical community. The board’s key objectives include:

Enhancing clinical and scientific rigor in diagnostic assay development.
Validating the sensitivity and specificity of its biomarker panels.
Bridging relationships with prestigious hospitals, universities, and research institutions.
Guiding the design and execution of international clinical trials.

The Scientific Advisory Board has included distinguished key opinion leaders such as Josep Tabernero (President of the European Society for Medical Oncology – ESMO), Uri Ladabaum (Director of the Gastrointestinal Cancer Prevention Program at Stanford University), Antoni Castells (Medical Director at Hospital Clínic de Barcelona, Spain), James Kinross (Reader in Colorectal Surgery at Imperial College London), and Uwe Bicker (Oncologist associated with Sanofi, Germany).

Furthermore, Universal DX has built an extensive collaborative network with leading biotechnology and biomedical research hubs, including Imperial College Healthcare NHS Trust in London and the Austrian Institute of Technology. The company collaborates with over 80 hospitals across six countries, including Hospital La Paz and MD Anderson Cancer Center in Madrid (Spain), Hospital Clínic in Barcelona (Spain), and St. Mary’s Hospital in London, alongside access to more than 200 biobanks worldwide.

Central to this execution is an experienced multidisciplinary team of 100 professionals spanning scientists, clinical researchers, regulatory managers, and tech entrepreneurs. Juan Martínez-Barea serves as Executive Chairman, with Marko Bitenc leading product strategy as Chief Innovation Officer (CIO).

Through these assets, the company has engineered a proprietary multi-omics platform that isolates unique genomic and epigenomic signatures associated with distinct cancer types. The pipeline features Signal-C® (colorectal cancer detection) alongside Signal-Li® and Signal-Lu® under development for liver and lung cancer, respectively.

As Juan Martínez-Barea stated in a 2023 media interview: “In 2012, we founded UDX with a bold vision: to transform cancer into a curable disease through early detection using a simple blood draw. With Signal-C’s performance results presented at DDW, our strategic partnership with Quest Diagnostics, the premier leader in our industry, our recent funding round, and the initiation of our FDA trial, we are significantly closer to fulfilling that mission and establishing ourselves as a global leader in early cancer detection”.

Market Outlook: The addressable market for early colorectal cancer screening in developed economies exceeds €18 billion. Within the next decade, annual liquid biopsy screenings could well become standard clinical practice globally.

Global Cancer Mortality Distribution (2020)

Further Information

This case study summarizes the journey of Universal DX, a landmark success story within the healthtech and medtech sectors, pioneering a proprietary liquid biopsy platform to detect cancer from a single drop of blood. We hope you found this overview insightful. If you are seeking entrepreneurial inspiration or are interested in deep-tech innovation, explore additional case studies and analysis across our site using the search tool located in the header.

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Bibliography

Although the content of this blog is intended for educational and informative purposes, we take data verification very seriously. Our articles are the result of interviews with key figures and industry experts, as well as meticulous research across official sources, media outlets, scientific publications, and in-depth reports. Because of this, the stories we share are often recognized by their own protagonists as highly accurate. In any case, if you spot any errors or inaccuracies, we would be incredibly grateful if you could leave a comment at the end of the article or let us know at blog@carballar.com.

However, as a non-profit, educational blog, we operate with a lean approach, which means we cannot dedicate the time required to exhaustively reference every single piece of data presented. Nevertheless, should you need to verify any of the figures or information, we have attached some of the primary sources utilized below. Please keep in mind that, since this is a Spanish company, the majority of these sources are in Spanish.