What SkylineDx does

SkylineDx is a privately held molecular diagnostics company headquartered in Rotterdam, Netherlands, founded in 2013 to commercialize academically discovered biomarkers into clinically validated diagnostic assays. The company operates two clinical laboratories — its ISO 13485:2016-certified headquarters in Rotterdam and a CAP/CLIA-certified laboratory in San Diego, California — enabling it to deliver tests as laboratory-developed tests (LDTs) in the United States and as CE-IVD/UKCA-marked kits in Europe.

The company's core technology is the CP-GEP (Clinicopathologic and Gene Expression Profile) architecture, which combines clinical variables with gene expression profiling data into a single integrated algorithm that stratifies patients into binary High or Low Risk categories. Its two commercialized products are Merlin CP-GEP for cutaneous melanoma (predicting sentinel lymph node biopsy metastasis risk) and SKY92 (marketed as MMprofiler in Europe) for multiple myeloma prognosis. Both products are deployed on qRT-PCR and microarray platforms. The Merlin test became the first and only molecular diagnostic recognized by the NCCN Clinical Practice Guidelines in Oncology (Version 1.2026) for assessing metastatic risk in select early-stage melanoma patients. Pipeline programs include SCCore GEP for cutaneous squamous cell carcinoma and KiDs-GEP for early diagnosis of Kawasaki disease, supported by research collaborations with Mayo Clinic, Erasmus MC, Imperial College London, UC San Diego, and UCSF.

SkylineDx monetizes through fee-for-service diagnostic testing ordered by healthcare providers, with revenue generated via its direct laboratory testing channel in the U.S. and partner-distributed CE-IVD kits in Europe. Pricing is quote-based and not publicly disclosed. The go-to-market is enterprise field sales targeting academic medical centers, leading oncology centers, and dermatology practices, with the NCCN guideline inclusion serving as the primary adoption lever. The company employs a team of over 70 international experts across scientific, bioinformatics, lab operations, commercial, QA/RA, and administrative functions, and was awarded the 2025 BioTech Breakthrough Award for 'Diagnostics Company of the Year.'

Name

SkylineDx

Legal name

SkylineDx B.V.

Website

https://skylinedx.com

Company type

Private

Founded year

2013

Operating status

Operating

Headcount range

51–100 employees

Short description

SkylineDx is a Rotterdam-based molecular diagnostics company that develops and commercializes gene expression profile tests for oncology and inflammatory diseases, offering Merlin CP-GEP for cutaneous melanoma risk stratification and SKY92 for multiple myeloma prognosis to clinicians globally.

Ownership category

akta.pro rank

Product category

Molecular Diagnostics

NAICS

Medical Laboratories (621511), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Services-Medical Laboratories (8071)

akta.pro primary industry

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

akta.pro secondary industries

Prognostic & Risk Stratification Biomarkers (disease progression, recurrence risk) (HLAAAMAF), Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays) (HLAAAMAC)

Keywords

• Molecular diagnostics services
• Gene expression profiling
• Melanoma diagnostic testing
• Multiple myeloma prognosis
• Clinical laboratory diagnostics

Headquarters

HQ city

Rotterdam

HQ country

Netherlands

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Molecular Diagnostic Testing Services: SkylineDx operates CAP/CLIA-certified clinical laboratories in San Diego (USA) and Rotterdam (Netherlands) providing diagnostic testing services. Tests are marketed as laboratory-developed tests (LDT) in the USA and CE-IVD/UKCA marked kits in Europe. Revenue is generated through test ordering by healthcare providers and clinical institutions.

Go-to-market motion1 record

Distribution channels3 records

Marketing channels6 records

Core offering

SkylineDx develops and commercializes signature-based molecular diagnostic tests that analyze patient gene expression combined with clinicopathologic variables to stratify disease risk. Its commercial portfolio includes the Merlin CP-GEP Test for cutaneous melanoma (predicting sentinel lymph node metastasis risk) and the SKY92 test for multiple myeloma prognosis. Tests are delivered through the company's CAP/CLIA laboratory in San Diego (as Laboratory Developed Tests in the US) and as CE-IVD/UKCA marked kits (Merlin Assay, MMprofiler) in Europe. The company also runs a STRIX innovation engine that evaluates and in-licenses new biomarkers from academic partners for development into commercial diagnostic assays.

Product overview

SkylineDx is a molecular diagnostics company offering two commercially available genomic assay tests: the Merlin CP-GEP Test for cutaneous melanoma risk stratification and the SKY92 test for multiple myeloma prognosis. The Merlin CP-GEP combines clinicopathologic features with gene expression profiling to predict sentinel lymph node metastasis, enabling clinicians to identify low-risk patients who may forgo invasive surgery. SKY92 analyzes 92 genes in malignant plasma cells to identify high-risk multiple myeloma patients requiring intensified treatment. The company operates research programs (Falcon for dermato-oncology, Panthera for hematology, Delphia for infectious/inflammatory diseases) and maintains an innovation engine (STRIX) to evaluate and license new biomarkers. Products are available in both the US (as LDTs) and Europe (CE-IVD/UKCA marked).

Differentiator

Problem solved

Functional benefit

Brands

• Merlin Test / Merlin Assay / Merlin CP-GEP: A gene expression profile test for cutaneous melanoma that predicts sentinel lymph node metastasis risk. Marketed as Merlin Assay in EU (CE-IVD) and Merlin CP-GEP in the USA (LDT).
• SKY92 / MMprofiler
• CP-GEP
• KiDs-GEP

Products and services

• Merlin CP-GEP Test (Merlin Test / Merlin Assay) A clinicopathologic and gene expression profile (CP-GEP) test for cutaneous melanoma that predicts sentinel lymph node metastasis risk. It combines clinicopathologic variables with gene expression profiling to stratify patients into High or Low Risk categories, enabling identification of patients who may safely forgo invasive sentinel lymph node biopsy. Developed with Mayo Clinic; commercially available in the US as an LDT and in the EU/UK as a CE-IVD/UKCA marked Merlin Assay kit.
• SKY92 (MMprofiler) A gene expression profiling test that analyzes 92 genes in malignant plasma cells to determine multiple myeloma prognosis and risk stratification. Identifies high-risk myeloma patients who may require more intensive treatment. Developed with Erasmus MC; commercially available in the US as an LDT and in the EU as a CE-IVD/UKCA marked MMprofiler assay kit.
• KiDs-GEP Classifier (Kawasaki Disease)

Quantifiable outcome

• Merlin CP-GEP reduced SLNB rates by over 40% in Danish multicenter validation study
• +8 more outcomes

Named customers2 records

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability3 records

Feature6 records

Partnerships

Five partnerships are on record, tiered core and secondary.

• Mayo Clinic (USA)coreStrategic or Co-development PartnerMayo Clinic co-developed the CP-GEP (Merlin CP-GEP) algorithm with SkylineDx. The Merlin CP-GEP test was developed through this collaboration and is exclusively licensed to SkylineDx. Mayo Clinic is a key partner in clinical validation and ongoing research collaboration.
• Erasmus Medical Center (Rotterdam, Netherlands)coreStrategic or Co-development PartnerErasmus MC is the licensor of the SKY92 gene expression signature to SkylineDx. The partnership has enabled the development and commercialization of the SKY92 multiple myeloma prognostic test. Erasmus MC is also a collaboration partner in the Falcon R&D Program for dermato-oncology and the international research on cutaneous squamous cell carcinoma.
• Imperial College London (UK)secondaryStrategic or Co-development PartnerImperial College London collaborates with SkylineDx on the Delphia R&D Program for Kawasaki disease diagnostics. Together with UC San Diego School of Medicine, they developed the KiDs-GEP classifier for early diagnosis of Kawasaki disease.
• University of California, San Francisco (UCSF)secondaryStrategic or Co-development PartnerUCSF is part of an international research collaboration with SkylineDx and Erasmus Medical Center on cutaneous squamous cell carcinoma. The collaboration conducted the largest omics characterization of CSCC to date, involving RNA-sequencing of 366 tumors and whole-exome sequencing of 147 tumors.
• BioInvent International ABsecondaryStrategic or Co-development PartnerBioInvent has worked with SkylineDx since 2019 on research projects focused on advancing personalized care in cancer. SkylineDx has provided molecular diagnostics expertise supporting BioInvent's development of novel immuno-modulatory antibodies for cancer therapies.

Scale indicators6 records

Recent moves8 records

Expansion highlights6 records

Direct peers

• Castle Biosciences: Castle Biosciences' DecisionDx-Melanoma is the most direct U.S. competitor to Merlin CP-GEP for cutaneous melanoma risk stratification. Both companies sell gene-expression-based molecular prognostic tests targeting the same dermatology and surgical oncology call points, with similar LDT-based U.S. commercialization models.
• Adaptive Biotechnologies: Adaptive Biotechnologies' clonoSEQ is an FDA-cleared MRD test for multiple myeloma and other lymphoid malignancies. It directly overlaps SKY92 in the multiple-myeloma prognostic and treatment-decision workflow, addressing the same hematology customer segment with a different but related molecular approach.

Broad incumbents

• Veracyte: Veracyte operates a portfolio of genomic diagnostics including Prosigna (breast cancer) and the Decipher urologic oncology tests. It is a broader incumbent in oncology molecular diagnostics with established U.S. sales infrastructure and reimbursement track record relevant to scaling SkylineDx-style GEP products.
• NeoGenomics: NeoGenomics is a large clinical oncology laboratory providing a broad menu of molecular and hematology-oncology testing services, including multiple-myeloma prognostic workups. It competes indirectly with SKY92 and is a relevant reference for commercial scale and reimbursement strategy in the same call points.
• Natera: Natera operates Signatera (tumor-informed MRD) and a broader reproductive and oncology testing menu. Its oncology commercial footprint and LDT-to-FDA-cleared hybrid regulatory model are directly comparable to SkylineDx's strategy of building guideline-anchored molecular diagnostic franchises.
• Exact Sciences: Exact Sciences owns Oncotype DX (breast, prostate, colon cancer recurrence) and Cologuard, making it a broad incumbent in cancer molecular diagnostics. The Oncotype DX franchise in particular is a model for how a gene-expression-based oncology test scales commercially once reimbursement and guideline inclusion are achieved.
• Guardant Health: Guardant Health is a liquid-biopsy leader with Guardant360 and Guardant Reveal. While technology-different (cell-free DNA vs. tissue GEP), it competes for the same oncology precision-medicine budget and shares SkylineDx's need to secure guideline inclusion, payer coverage, and physician adoption across multiple solid tumors.
• Myriad Genetics: Myriad Genetics offers a broad hereditary and tumor-profiling testing menu (BRACAnalysis, myChoice HRD, etc.) and is a relevant broad incumbent in molecular diagnostics. Its experience navigating reimbursement and regulatory pathways informs comparable scale-up strategies for niche GEP players like SkylineDx.
• Foundation Medicine: Foundation Medicine, a Roche subsidiary, provides comprehensive genomic profiling (FoundationOne CDx) and is a broad incumbent in oncology molecular diagnostics. While focused on broad tumor profiling rather than narrow GEP stratification, it competes for the same oncology precision-medicine budget and physician mind-share.

Emerging players

• Personalis: Personalis is a cancer genomics company with its NeXT Personal MRD test and tumor profiling offerings, comparable in size and stage to SkylineDx. Both companies are building molecular diagnostic franchises in oncology with a focus on proprietary algorithms and prospective clinical validation studies.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key highlights7 records

Customer concentration

• Xx.com/skylinedx
• LinkedInlinkedin.com/company/skylinedx-bv
• Facebookfacebook.com/skylinedx92

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles14 records

Subsidiaries1 record

Funding overview

Funding rounds3 records

Investors2 records

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

M&A

Investments1 record

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

Frequently asked questions about SkylineDx