Founded in 2013, SkylineDx developed into a global and leading molecular diagnostics company. Very lean and efficient, we were able to reach all major milestones from in-licensing intellectual property rights to signing partnerships executing the commercialization in both the United States and Europe.
Meanwhile, we were expanding our network of clinical collaborators including esteemed cancer centers, executing analytical, clinical validation, utility studies, and building value dossiers that should result in reimbursement and guideline inclusion. For our European CE-IVD route, every step is controlled under the stringent ISO-13485 prior to the products being marketed. Our San Diego (CA, USA) based clinical laboratory operates at the highest level of quality laboratory standards. It was granted CAP accreditation in June 2019, following its CLIA certification in December 2018. We pride ourselves on reaching these landmarks without losing sight of what we think is truly important: improving a patient’s quality of life.
With two high-performing tests available commercially, we strive to empower care providers and patients in personalized treatment decision-making and address large unmet medical needs in the respective fields.
Many more unmet needs could benefit from molecular diagnostic guidance. STRIX Program is our innovation engine that secures new, high-potential biomarkers to progress our current development pipeline.
Partner with us in pioneering genomic diagnostics. Your impactful contributions will allow patients to be diagnosed faster, more accurately, forgo unnecessary surgery, and support shared decision-making on personalized care strategies.
collaborations
We have formed strong partnerships with renowned institutes like Mayo Clinic, Erasmus MC, and Imperial College London, collaborating in various stages of diagnostic development.
publications
Global
Our knowledge-sharing goes beyond Europe and North America. We gain our initial invaluable insights by combining US and European perspectives. From there, we determine where the diagnostic test could have the best positive impact on health care.
Biobanks
Through our clinical studies, we build (access to) highly valuable biobanks. This allows us to do additional validation steps quicker, and discover new biomarkers- extending our pipeline faster.
Newest publications
Findings in a combined US and EU multi-center validation study show the potential ability of CP-GEP to support in risk stratifying patients with T1a melanoma.
Findings in a combined US and EU multi-center validation study show the potential ability of CP-GEP to support in risk stratifying patients with T1a melanoma.
By integrating an risk prediction model with established staging systems like AJCC/BWH, we’ve refined risk stratification in cutaneous squamous cell carcinoma. This empowers the identification of subgroups within lower stages, enhancing personalized follow-up schedules for improved patient outcomes.
Poster presented by Dr. Yu from University Hospital Cleveland Medical Center at AAD 2024. The abstract concludes that the CP-GEP assay improved risk stratification for nodal metastasis and disease recurrence in patients with cutaneous melanoma
What others have to say about us
ROTTERDAM (the Netherlands), SAN DIEGO (CA, USA), December 7, 2024—SkylineDx, an innovative diagnostics company specializing in the research and development of molecular diagnostics for oncology, inflammatory, and infectious diseases, announce that groundbreaking...
ROTTERDAM (the Netherlands), SAN DIEGO (CA, USA), October 25, 2024—SkylineDx, an innovative diagnostics company specializing in the research and development of molecular diagnostics for oncology, inflammatory, and infectious diseases, announced today the...
The Merlin test (CP-GEP) stratifies melanoma patients based on risk for sentinel lymph node (SLN) metastasis, offering a powerful tool for risk-based decision-making. ROTTERDAM (the Netherlands), SAN DIEGO (CA, USA), October 13,...
The Merlin Test (CP-GEP) Accurately Stratifies Cutaneous Melanoma Patients as Low Risk or High Risk for Sentinel Lymph Node Metastases Impacting Clinical Decision Making ROTTERDAM (the Netherlands), SAN DIEGO (CA, USA), October...
ROTTERDAM, (the Netherlands), SAN DIEGO (CA, USA), October 8, 2024 – SkylineDx, an innovative diagnostics company specializing in the research and development of molecular diagnostics for oncology, inflammatory, and infectious diseases, announces...
ROTTERDAM (the Netherlands), SAN DIEGO (CA, USA), July 9, 2024: — SkylineDx, an innovative diagnostics company specializing in the research and development of molecular diagnostics for oncology, inflammatory, and infectious diseases, proudly...
