REVEAL GENOMICS, S.L.

What REVEAL GENOMICS, S.L. does

REVEAL GENOMICS, S.L. is a Barcelona-based biotechnology company founded in 2020 as a spin-off of Hospital Clínic-IDIBAPS, the Vall d'Hebron Institute of Oncology (VHIO), and the University of Barcelona. It develops RNA-based genomic diagnostic tests for breast cancer built on three proprietary assays: HER2DX®, a 27-gene expression test that combines four biological signatures (immune infiltration, luminal differentiation, tumor cell proliferation, HER2 amplicon expression) with clinical staging to deliver risk, pCR likelihood, and ERBB2 scores for HER2+ early-stage breast cancer; DNADX®, a ctDNA/tumor DNA platform that uses a proprietary machine-learning model (published in Nature Communications, 2019 and 2023) for CNA-based molecular subtyping and biomarker identification across 126 breast cancer-related genes; and TNBCDX®, a 15-gene assay purpose-built for early-stage triple-negative breast cancer. The portfolio has been validated across more than 5,000 patients in over 11 international studies, including an individual patient-level meta-analysis of 2,518 patients published in The Lancet Oncology.

The underlying technology combines proprietary ML-driven gene-expression and copy-number algorithms applied to FFPE tissue and plasma ctDNA, paired with sample-processing infrastructure in a CLIA-certified, CAP-accredited US laboratory (CLIA# 34D2302687, CAP# 9841153) and a centralized European service at Hospital Clínic de Barcelona operated under IVDR Article 5(5) exemption. HER2DX is the lead commercial product, marketed as a CE-marking-in-progress IVD available in Europe and as an LDT through the US CLIA lab. DNADX and TNBCDX are currently offered in Research Use Only (RUO) format, with planned clinical commercialization in 2025 and 2027 respectively.

REVEAL GENOMICS operates an enterprise field-sales and conference-driven go-to-market, with per-test processing fees paid by healthcare institutions and academic medical centers ordering through a dedicated portal (orders.reveal-genomics.com). Customers include Vall d'Hebron, Hospital Clínic, Dana-Farber Cancer Institute, ICO L'Hospitalet, and clinical trial consortia such as ECOG-ACRIN, MEDSIR, and the DEFINITIVE trial consortium. The company employs 1-10 people and has been financed through public funding including a CDTI NEOTEC 2023 grant and a €2 million participatory loan from Avançesa (December 2025), with a US subsidiary (REVEAL GENOMICS, Inc.) supporting transatlantic expansion.

Name

REVEAL GENOMICS, S.L.

Legal name

REVEAL GENOMICS, S.L.

Website

https://reveal-genomics.com

Company type

Private

Founded year

2020

Operating status

Operating

Headcount range

11–50 employees

Short description

REVEAL GENOMICS, S.L. is a Barcelona-based biotech developing RNA-based genomic diagnostic tests for breast cancer. Its HER2DX®, DNADX®, and TNBCDX® assays are sold to oncologists via a direct ordering portal, with samples processed in CLIA-certified labs to guide personalized treatment.

Ownership category

akta.pro rank

Product category

Cancer Genomic Diagnostics

NAICS

Medical Laboratories (621511), Medical and Diagnostic Laboratories (62151)

SIC

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

akta.pro primary industry

Oncology Diagnostics (tumor profiling, MRD, liquid biopsy) (HLAAALAE)

akta.pro secondary industries

Molecular Tumor Boards & Clinical Interpretation Services (HLAAANAD), Biomarker Discovery & Validation (omics, assay feasibility, clinical validation) (HLAAAMAA), Molecular Diagnostics & Genomics Laboratories (HLAFAMAE), Molecular & Genetic Testing (PCR/NGS/qPCR) (HLAGADAF)

Keywords

• Genomic diagnostic tests
• Breast cancer diagnostics
• Precision oncology
• RNA gene expression assays
• Companion diagnostics

Headquarters

HQ city

Barcelona

HQ country

Spain

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. HER2DX genomic test sales: HER2DX is a commercial genomic diagnostic test sold to healthcare professionals and institutions. Physicians order the test through the company's portal, samples are processed at the company's CLIA-certified lab (US) or at Hospital Clínic de Barcelona (EU), and results are returned for clinical decision-making. HER2DX is CE marked (in process) in Europe and available under IVDR exemption via Hospital Clínic.
2. DNADX research and future clinical use licensing: DNADX is currently available as Research Use Only (RUO) format. The company is standardizing the assay with plans to offer it for clinical use by 2027. Revenue will come from test processing fees once clinically available.
3. TNBCDX research and future clinical use licensing: TNBCDX is currently available in RUO format with plans for clinical availability by 2025 through the Biomedical Diagnostic Center at Hospital Clínic. Revenue model will be test processing fees upon commercialization.

Go-to-market motion2 records

Distribution channels3 records

Marketing channels5 records

Core offering

REVEAL GENOMICS develops and commercializes RNA-based genomic diagnostic tests for breast cancer. Its portfolio includes HER2DX, a 27-gene expression assay for HER2-positive breast cancer that generates risk, pathological complete response (pCR), and ERBB2 scores from FFPE tumor tissue; DNADX, a ctDNA/tumor DNA analysis platform providing molecular subtyping and biomarker identification for advanced/metastatic breast cancer; and TNBCDX, a 15-gene assay for early-stage triple-negative breast cancer. Tests are processed in the company's CLIA/CAP-certified US laboratory and via Hospital Clínic de Barcelona in Europe, with results returned to oncologists for treatment decision-making.

Product overview

REVEAL GENOMICS develops and commercializes innovative genomic diagnostic tests for precision oncology in breast cancer. The company operates a portfolio of three distinct genomic assay products: HER2DX® for early-stage HER2-positive breast cancer prognosis and treatment guidance, DNADX® for advanced breast cancer molecular subtyping via tissue or liquid biopsy analysis, and TNBCDX® for early-stage triple-negative breast cancer risk assessment. These tests utilize proprietary machine learning algorithms and gene expression analysis to guide personalized treatment decisions. HER2DX is the company's lead product with clinical use established, while DNADX and TNBCDX are currently in Research Use Only (RUO) format with plans for clinical use.

Differentiator

Problem solved

Functional benefit

Brands

• HER2DX: First genomic test for patients with HER2+ breast cancer that measures expression of 27 genes to predict relapse risk, therapy response probability, and tumor HER2 expression levels
• DNADX
• TNBCDX

Products and services

• HER2DX® The first genomic test for patients with HER2+ breast cancer. It measures expression of 27 genes from FFPE breast cancer tissues, evaluating immune infiltration, luminal differentiation, tumor cell proliferation, and HER2 amplicon expression, combined with clinical staging data (tumor stage, nodal stage) to provide a Risk Score, pCR Likelihood Score, and ERBB2 score. Used by oncologists to guide treatment escalation/de-escalation decisions in HER2-positive breast cancer. Validated in >5,000 patients.
• DNADX® A genomic test that analyzes tumor tissue or plasma circulating tumor DNA (ctDNA) for advanced/metastatic breast cancer. It provides CNA-based molecular subtyping, reports SNVs and indels in 126 breast cancer-related genes (including AKT1, BRAF, BRCA1/2, ESR1, ERBB2, PIK3CA, PTEN), genome-wide copy number alterations, 150 CNA-based signatures, 5-subtype classification, and tumor fraction estimation in plasma. Based on proprietary machine-learning models.
• TNBCDX® The first genomic test designed specifically for patients with early-stage Triple-Negative Breast Cancer (TNBC). It integrates clinical variables with key tumor and immune biological factors across 15 genes to provide a risk score and pCR likelihood score, and measures ERBB2 levels to confirm TNBC classification. Validated in two independent studies with 418 patients.

Quantifiable outcome

• HER2DX low-risk patients achieved 6-year event-free survival of 93.6% vs 82.9% for high-risk (absolute difference 10.7%, HR 2.55)
• +6 more outcomes

Named customers6 records

Segments5 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability7 records

Feature5 records

Partnerships

Twelve partnerships are on record, tiered minor and core.

• DEKRA Certification B.V.minorOthers · 16 September 2025DEKRA Certification B.V. conducted the rigorous two-stage audit that resulted in REVEAL GENOMICS receiving ISO 13485:2016 certification for its Quality Management System covering in vitro diagnostic software design, development, and distribution.
• Ona TherapeuticscoreStrategic or Co-development Partner · 14 April 2025Strategic collaboration where REVEAL GENOMICS conducts comprehensive molecular analysis of tumor and blood samples from the ONA-255 phase 1-2 clinical trial using proprietary technologies. Dr. Aleix Prat (REVEAL CSO) identified the ONA-255 drug target and leads Ona's advisory board. CDTI-funded grant supports the partnership via REVEAL's US subsidiary.
• Hospital Clínic de BarcelonacoreStrategic or Co-development PartnerHospital Clínic de Barcelona is a founding institution of REVEAL GENOMICS (spin-off of Hospital Clínic – IDIBAPS – University of Barcelona and VHIO). It provides HER2DX testing in Europe under the IVDR exemption (Article 5(5) of Regulation EU 2017/746). Also hosts the CDB-HCB for DNADX/TNBCDX centralized service.
• Vall d'Hebron Institute of Oncology (VHIO)coreStrategic or Co-development PartnerVHIO is a founding institution of REVEAL GENOMICS spin-off alongside Hospital Clínic and University of Barcelona. Hosts CELLEX-VHIO for centralized DNADX service. Guillermo Villacampa (VHIO) led the Lancet Oncology meta-analysis. Dr. Aleix Prat serves as VHIO investigator and Co-founder.
• Dana-Farber Cancer Institute (DFCI)coreStrategic or Co-development PartnerDFCI led key studies evaluating HER2DX and DNADX in metastatic breast cancer patients treated with T-DXd. The RELIEVE study (80 patients) analyzed plasma samples demonstrating DNADX and HER2DX associations with patient outcomes. Dr. Sara Tolaney (DFCI) is senior author on multiple publications.
• MEDSIRcoreStrategic or Co-development PartnerMEDSIR designed and coordinated the PARSIFAL phase II trial evaluating DNADX in 122 plasma samples from HR+/HER2- metastatic breast cancer patients. MEDSIR and REVEAL also partnered on the PHERGain trial. Strategic partnership for independent clinical research in breast cancer.
• ECOG-ACRIN Cancer Research GroupcoreStrategic or Co-development PartnerECOG-ACRIN conducted the COMPASSHER2 pCR (EA1181) trial with HER2DX as a pre-specified secondary endpoint, evaluating neoadjuvant THP in >2,000 patients. HER2DX pCR score prospectively validated showing superior predictive ability vs TILs alone.
• University of BarcelonacoreStrategic or Co-development PartnerUniversity of Barcelona is a founding institution of the REVEAL GENOMICS spin-off alongside Hospital Clínic-IDIBAPS and VHIO. Dr. Aleix Prat is Professor of Medicine at University of Barcelona.
• Catalan Institute of Oncology (ICO L'Hospitalet)coreStrategic or Co-development PartnerICO L'Hospitalet conducted the BionHER phase II trial evaluating HER2DX in 83 HER2+ breast cancer patients treated with neoadjuvant THP. Dr. Sònia Pernas is Principal Investigator. HER2DX achieved AUC of 0.835 for pCR prediction.
• West German Study GroupminorStrategic or Co-development PartnerLed by Dr. Nadia Harbeck and Dr. Oleg Gluz, the WSG conducted the ADAPT-TN phase II neoadjuvant trial for TNBCDX validation in early-stage TNBC patients.
• Hospital General Universitario Gregorio MarañónminorStrategic or Co-development PartnerLed by Dr. Miguel Martin, this center conducted the MMJ-CAR-2014-01 trial for TNBCDX validation in early-stage TNBC patients treated with carboplatin and docetaxel.
• DEFINITIVE Trial Consortium (NCT06446882)coreStrategic or Co-development PartnerEU-funded international multicenter randomized prospective clinical trial across Europe and Israel evaluating HER2DX-guided treatment in stage II-III HER2+ breast cancer. First 122 patients screened showing 94.3% success rate and 7-day median TAT.

Scale indicators11 records

Recent moves8 records

Expansion highlights6 records

Direct peers

• Agendia: Agendia develops MammaPrint and BluePrint, genomic assays for early-stage breast cancer that provide recurrence risk and molecular subtyping. Directly competes with HER2DX in guiding adjuvant treatment decisions for breast cancer patients.
• Guardant Health: Guardant Health is a leader in liquid biopsy and ctDNA-based oncology testing, with breast cancer applications including HRD and mutation profiling. Directly comparable to REVEAL's DNADX platform for advanced/metastatic breast cancer biomarker identification.
• Exact Sciences: Exact Sciences owns Oncotype DX, the most widely adopted genomic test for early-stage breast cancer treatment decisions. Both companies sell RNA-expression-based breast cancer assays that inform escalation/de-escalation of therapy, making Oncotype DX the closest direct competitor to HER2DX.

Broad incumbents

• Foundation Medicine (Roche): Foundation Medicine offers comprehensive genomic profiling (FoundationOne CDx) used widely in advanced cancer, including breast cancer. Competes with DNADX in tissue/plasma-based molecular subtyping and biomarker discovery for metastatic breast cancer.
• NeoGenomics: NeoGenomics is a clinical reference laboratory offering comprehensive oncology testing including breast cancer panels. Comparable as a broader oncology diagnostics services provider with established US laboratory infrastructure competing with REVEAL GENOMICS, Inc.
• Veracyte: Veracyte is a genomic diagnostics company with a broad oncology/urology portfolio, including the Prosigna breast cancer test (based on the PAM50 gene signature closely associated with REVEAL's scientific leadership). Competes across multiple indications with deeper commercial scale.

Emerging players

• Biodesix: Biodesix develops blood-based molecular diagnostic tests for cancer, primarily in lung cancer. Adjacent comparable in using genomic/proteomic biomarkers and proprietary algorithms to guide treatment decisions, though with a different cancer focus than REVEAL's breast cancer specialization.
• Tempus AI: Tempus provides AI-enabled precision medicine via genomic sequencing and data analytics in oncology, including breast cancer. Comparable to REVEAL in combining proprietary algorithms with molecular data to guide therapy decisions across tumor types.
• Natera: Natera provides Signatera, a tumor-informed ctDNA test used for MRD monitoring and treatment response across solid tumors including breast cancer. Comparable to REVEAL's ctDNA-based approach in DNADX with focus on longitudinal monitoring.
• Caris Life Sciences: Caris offers molecular profiling and AI-driven multi-omic testing (MI Profile, Caris Assure) for oncology. Comparable to REVEAL in offering tissue and liquid biopsy profiling with proprietary algorithms for treatment selection in advanced cancer.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights7 records

Customer concentration

• Xx.com/RevealGenomics
• LinkedInlinkedin.com/company/reveal-genomics

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 records

Subsidiaries1 record

Funding overview

Funding rounds

Investors

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 REVEAL GENOMICS, S.L.