# Universal DX
Universal DX (Universal Diagnostics, S.A.) is a Spanish liquid-biopsy company, founded in Seville in 2012 and promoted by Juan Martínez Barea, that develops blood tests for early cancer detection, starting with colorectal cancer; it remains an operating, privately held company as of the latest available records in 2025.[1](https://www.cdti.es/en/node/19013) • [3](https://www.eib.org/en/press/all/2025-104-eib-finances-with-eur20-million-universal-dx-to-develop-innovative-diagnostic-tests-for-early-cancer-detection) Its lead product, Signal-C, is a blood test intended to detect early colorectal cancer, including advanced adenomas, and the company is running a large US clinical trial to seek premarket approval from the FDA.[1](https://www.cdti.es/en/node/19013) • [5](https://www.businesswire.com/news/home/20240807274324/en/Universal-DX-Initiates-Clinical-Trial-for-FDA-Approval-of-Signal-C-Colorectal-Cancer-Screening-Blood-Test)
| Key facts | |
|---|---|
| Founded | 2012, Seville, Spain, promoted by Juan Martínez Barea (Founder and Chairman)[1](https://www.cdti.es/en/node/19013) • [3](https://www.eib.org/en/press/all/2025-104-eib-finances-with-eur20-million-universal-dx-to-develop-innovative-diagnostic-tests-for-early-cancer-detection) |
| Lead product | Signal-C, a blood test for early colorectal cancer detection including advanced adenomas[1](https://www.cdti.es/en/node/19013) |
| Technology | Next-generation sequencing of methylation, fragmentation, and microbiome biomarkers, combined with machine-learning bioinformatics[3](https://www.eib.org/en/press/all/2025-104-eib-finances-with-eur20-million-universal-dx-to-develop-innovative-diagnostic-tests-for-early-cancer-detection) |
| Series B | Initial close of approximately $70 million announced November 2023, including Quest Diagnostics; closed August 2024 with Olympus Innovation Ventures joining[4](https://newsroom.questdiagnostics.com/2023-11-20-Universal-DX-Announces-Strategic-Collaboration-with-Quest-Diagnostics-to-Bring-Advanced-Colorectal-Cancer-Screening-Blood-Test-to-Patients-and-Providers-in-the-United-States) • [5](https://www.businesswire.com/news/home/20240807274324/en/Universal-DX-Initiates-Clinical-Trial-for-FDA-Approval-of-Signal-C-Colorectal-Cancer-Screening-Blood-Test) |
| 2025 financing | €62 million round including €29.9 million from Spain's SETT, plus a €20 million European Investment Bank loan[2](https://sett.gob.es/la-sett-formaliza-la-inversion-de-30-millones-de-euros-en-la-empresa-espanola-universal-dx-especializada-en-deteccion-temprana-de-cancer-con-ia/) • [3](https://www.eib.org/en/press/all/2025-104-eib-finances-with-eur20-million-universal-dx-to-develop-innovative-diagnostic-tests-for-early-cancer-detection) |
| Pivotal trial | 15,000-patient study (NCT06059963), first patient recruited January 2024, supporting an FDA premarket approval submission[5](https://www.businesswire.com/news/home/20240807274324/en/Universal-DX-Initiates-Clinical-Trial-for-FDA-Approval-of-Signal-C-Colorectal-Cancer-Screening-Blood-Test) |
| US commercial partner | Quest Diagnostics, holding exclusive US clinical laboratory service rights assuming FDA approval[4](https://newsroom.questdiagnostics.com/2023-11-20-Universal-DX-Announces-Strategic-Collaboration-with-Quest-Diagnostics-to-Bring-Advanced-Colorectal-Cancer-Screening-Blood-Test-to-Patients-and-Providers-in-the-United-States) |
## History and founding
Universal Diagnostics was founded in Seville in 2012 and promoted by Juan Martínez Barea, who serves as Founder and Chairman.[1](https://www.cdti.es/en/node/19013) • [3](https://www.eib.org/en/press/all/2025-104-eib-finances-with-eur20-million-universal-dx-to-develop-innovative-diagnostic-tests-for-early-cancer-detection) A RAIF fund managed by Adepa is the company's largest shareholder and has led all of its funding rounds since 2017.[1](https://www.cdti.es/en/node/19013) The company describes an international footprint: a November 2023 press release stated it was incorporated in Spain in 2012 with headquarters in Madrid and main offices in [Ljubljana](https://www.edgepedia.org/ljubljana), Slovenia, and [Cambridge, Massachusetts](https://www.edgepedia.org/cambridge-massachusetts), while Spanish government and [European Investment Bank](https://www.edgepedia.org/european-investment-bank) records describe it as Sevilla-based.[4](https://newsroom.questdiagnostics.com/2023-11-20-Universal-DX-Announces-Strategic-Collaboration-with-Quest-Diagnostics-to-Bring-Advanced-Colorectal-Cancer-Screening-Blood-Test-to-Patients-and-Providers-in-the-United-States) • [1](https://www.cdti.es/en/node/19013) • [3](https://www.eib.org/en/press/all/2025-104-eib-finances-with-eur20-million-universal-dx-to-develop-innovative-diagnostic-tests-for-early-cancer-detection)
## Products and technology
Signal-C is the company's first blood test, according to the company's own website; it is a blood test for early detection of colorectal cancer, including advanced adenomas, the precancerous lesions from which colorectal cancers develop.[7](https://www.universaldx.com/) • [1](https://www.cdti.es/en/node/19013) The assay uses next-generation sequencing to measure proprietary methylation, fragmentation, and microbiome biomarkers, and machine-learning bioinformatics to distinguish cancer patients from healthy people.[3](https://www.eib.org/en/press/all/2025-104-eib-finances-with-eur20-million-universal-dx-to-develop-innovative-diagnostic-tests-for-early-cancer-detection) • [1](https://www.cdti.es/en/node/19013) The company describes this approach as combining multi-omics, computational biology, and artificial intelligence.[1](https://www.cdti.es/en/node/19013)
The same platform is being extended to other cancers. The company is developing tests for lung, pancreas, liver, and esophageal cancer; the European Investment Bank's 2025 financing names two pipeline products, Signal-Li for liver cancer and Signal-Lu for lung cancer.[1](https://www.cdti.es/en/node/19013) • [3](https://www.eib.org/en/press/all/2025-104-eib-finances-with-eur20-million-universal-dx-to-develop-innovative-diagnostic-tests-for-early-cancer-detection)
## Funding, by the numbers
- **Series B, November 2023.** UDX announced the initial closing of its Series B financing of approximately $70 million, with investors including [Quest Diagnostics](https://www.edgepedia.org/quest-diagnostics), announced alongside the Quest commercial agreement.[4](https://newsroom.questdiagnostics.com/2023-11-20-Universal-DX-Announces-Strategic-Collaboration-with-Quest-Diagnostics-to-Bring-Advanced-Colorectal-Cancer-Screening-Blood-Test-to-Patients-and-Providers-in-the-United-States)
- **Series B close, August 2024.** The company announced completion of the Series B with existing investors including Quest Diagnostics and new investors including Olympus Innovation Ventures, funding the Signal-C FDA premarket approval trial; trade press reported the same closing.[5](https://www.businesswire.com/news/home/20240807274324/en/Universal-DX-Initiates-Clinical-Trial-for-FDA-Approval-of-Signal-C-Colorectal-Cancer-Screening-Blood-Test) • [6](https://www.medicaldevice-developments.com/news/universal-dx-starts-signal-c-colorectal-cancer-test-trial-for-fda-approval/)
- **€62 million round, 2025.** SETT, a public body under Spain's Ministry for Digital Transformation, formalized a €29.9 million investment, authorized by the [Council of Ministers](https://www.edgepedia.org/council-of-ministers) in January 2025, within a capital increase in which the company raised €62 million in total from several investors.[2](https://sett.gob.es/la-sett-formaliza-la-inversion-de-30-millones-de-euros-en-la-empresa-espanola-universal-dx-especializada-en-deteccion-temprana-de-cancer-con-ia/)
- **€20 million EIB loan, 2025.** The European Investment Bank signed a €20 million loan with Universal DX to support development and commercialization of its blood-based liquid biopsy tests and to advance the large US clinical trial for FDA approval and reimbursement.[3](https://www.eib.org/en/press/all/2025-104-eib-finances-with-eur20-million-universal-dx-to-develop-innovative-diagnostic-tests-for-early-cancer-detection)
## Clinical evidence and the Quest partnership
In a 1,000-patient study presented at Digestive Disease Week in May 2023, Signal-C demonstrated 93% sensitivity for colorectal cancer detection and 54% sensitivity for advanced adenomas, at 92% specificity overall.[4](https://newsroom.questdiagnostics.com/2023-11-20-Universal-DX-Announces-Strategic-Collaboration-with-Quest-Diagnostics-to-Bring-Advanced-Colorectal-Cancer-Screening-Blood-Test-to-Patients-and-Providers-in-the-United-States) The company's own website states a different figure, claiming the test detects colorectal cancer with 92% sensitivity and 94% specificity; the study figures reported at the Quest announcement are the ones cited here for performance.[7](https://www.universaldx.com/)
On November 20, 2023, UDX and Quest Diagnostics announced a commercial agreement under which Quest will perform clinical laboratory services in the United States based on Signal-C, assuming FDA premarket approval, with exclusive US rights for Quest.[4](https://newsroom.questdiagnostics.com/2023-11-20-Universal-DX-Announces-Strategic-Collaboration-with-Quest-Diagnostics-to-Bring-Advanced-Colorectal-Cancer-Screening-Blood-Test-to-Patients-and-Providers-in-the-United-States) To generate the evidence for that submission, UDX is enrolling patients in a 15,000-patient study across more than 100 investigator sites, with Quest's oncology center of excellence in [Lewisville, Texas](https://www.edgepedia.org/lewisville-texas), serving as the single testing site for the study.[4](https://newsroom.questdiagnostics.com/2023-11-20-Universal-DX-Announces-Strategic-Collaboration-with-Quest-Diagnostics-to-Bring-Advanced-Colorectal-Cancer-Screening-Blood-Test-to-Patients-and-Providers-in-the-United-States) The trial, registered as NCT06059963, recruited its first patient in January 2024 and targets enrolling at least 15,000 patients across 100 investigator sites.[5](https://www.businesswire.com/news/home/20240807274324/en/Universal-DX-Initiates-Clinical-Trial-for-FDA-Approval-of-Signal-C-Colorectal-Cancer-Screening-Blood-Test)
## Business model and customers
The company's customers are laboratories and large diagnostic operators in the United States, according to SETT; the Quest agreement is the concrete example, making Quest the channel through which Signal-C would reach US patients and providers if approved.[2](https://sett.gob.es/la-sett-formaliza-la-inversion-de-30-millones-de-euros-en-la-empresa-espanola-universal-dx-especializada-en-deteccion-temprana-de-cancer-con-ia/) • [4](https://newsroom.questdiagnostics.com/2023-11-20-Universal-DX-Announces-Strategic-Collaboration-with-Quest-Diagnostics-to-Bring-Advanced-Colorectal-Cancer-Screening-Blood-Test-to-Patients-and-Providers-in-the-United-States) SETT describes the strategy as first finalizing commercial approval of the colorectal test in the US, then a second phase to replicate the model in Europe.[2](https://sett.gob.es/la-sett-formaliza-la-inversion-de-30-millones-de-euros-en-la-empresa-espanola-universal-dx-especializada-en-deteccion-temprana-de-cancer-con-ia/) No source in the public record reports revenue, pricing, or adoption figures for the company.
## References
1. El CDTI Innovación invierte junto con Universal Dx S.C.A. SICAV-RAIF en Universal Diagnostics, S.A. — https://www.cdti.es/en/node/19013
2. La SETT formaliza la inversión de 30 millones de euros en Universal DX — https://sett.gob.es/la-sett-formaliza-la-inversion-de-30-millones-de-euros-en-la-empresa-espanola-universal-dx-especializada-en-deteccion-temprana-de-cancer-con-ia/
3. EIB finances with €20 million Universal DX to develop innovative diagnostic tests for early cancer detection — https://www.eib.org/en/press/all/2025-104-eib-finances-with-eur20-million-universal-dx-to-develop-innovative-diagnostic-tests-for-early-cancer-detection
4. Universal DX Announces Strategic Collaboration with Quest Diagnostics (November 20, 2023) — https://newsroom.questdiagnostics.com/2023-11-20-Universal-DX-Announces-Strategic-Collaboration-with-Quest-Diagnostics-to-Bring-Advanced-Colorectal-Cancer-Screening-Blood-Test-to-Patients-and-Providers-in-the-United-States
5. Universal DX Initiates Clinical Trial for FDA Approval of Signal-C (August 2024) — https://www.businesswire.com/news/home/20240807274324/en/Universal-DX-Initiates-Clinical-Trial-for-FDA-Approval-of-Signal-C-Colorectal-Cancer-Screening-Blood-Test
6. Universal DX starts Signal-C colorectal cancer test trial for FDA approval — https://www.medicaldevice-developments.com/news/universal-dx-starts-signal-c-colorectal-cancer-test-trial-for-fda-approval/
7. Universal DX — company site — https://www.universaldx.com/
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*Initially written Sep 17, 2026 · Edited: Oct 11, 2026; Oct 15, 2026*
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License: Edgepedia Community License 1.0, https://www.edgepedia.org/edgepedia/license