SkylineDx

SkylineDx is a molecular diagnostics company based in Rotterdam, The Netherlands. It describes its mission as transforming healthcare by offering scientifically robust and clinically relevant molecular diagnostic tests that address current unmet medical needs. The company focuses on gene-expression profiling and gene-signature-based diagnostics, measuring genomic alterations in a patient's disease to help care providers understand how a disease is likely to develop and to set out a more personalized treatment path. SkylineDx positions itself as disease-agnostic but with a clear focus: bridging the gap between academically discovered biomarkers and commercially available diagnostic assays. It collaborates with medical and academic centers in the United States and Europe to further develop biomarker discovery work, and once a test is launched commercially it signs commercial partnerships to strengthen sales and distribution. Its stated goal is to help clinicians diagnose faster, deselect patients from unnecessary procedures, and identify therapy responders, thereby improving patients' quality of life. The company organizes its research and development around dedicated disease programs, including dermatology, hematology, and inflammatory diseases. New biomarker opportunities are evaluated through an internal innovation engine called STRIX (Systematic, Translational R&D Workflow, building on Integrated Expertise), which screens and evaluates high-potential biomarkers each year. Promising biomarkers are then optimized, analytically and clinically validated, and, once regulatory requirements are met, branded and launched as commercial tests. A flagship commercial offering is the Merlin test family, including CP-GEP (Merlin CP-GEP), a predictive gene-expression profile test for cutaneous melanoma. According to the company, Merlin CP-GEP has been recognized by the NCCN Clinical Practice Guidelines in Oncology as a predictive GEP test that may be used in select cutaneous melanoma patients to assess metastatic risk, and it has received FDA Breakthrough Device Designation. SkylineDx presents itself as a science- and data-driven organization whose team is motivated by research, data science, and clinical relevance, and it emphasizes collaboration, integrity, and a culture of teamwork.

SkylineDx is a molecular diagnostics company located in Rotterdam, The Netherlands. Public information about its earliest founding date and founders is limited in the available evidence; the company presents itself as having been founded with a vision to personalize healthcare through state-of-the-art diagnostics, and it describes its story as one of passion, innovation, and dedication. From its base in Rotterdam, SkylineDx has built its business around gene-expression-based diagnostics. The company's core idea is that disease often harbors genomic changes in cells, and that measuring these genomic alterations can provide a better understanding of how a disease will develop over time. With that information, care providers can set out a more personalized treatment path, offering patients a better quality of life. SkylineDx describes itself as disease-agnostic while maintaining a clear focus: bridging the gap between academically discovered biomarkers and commercially available diagnostic assays. To pursue this mission, SkylineDx collaborates with medical and academic centers in the United States and Europe to further develop their foundational work in biomarker discovery. Once a test is launched commercially, the company signs commercial partnerships to strengthen sales and distribution. This model reflects a deliberate strategy of translating academic research into clinically relevant, commercially available tests. The company organizes its innovation efforts through an internal engine called STRIX (Systematic, Translational R&D Workflow, building on Integrated Expertise). Before a new molecular biomarker enters SkylineDx's R&D programs, it is thoroughly evaluated through STRIX to ensure that it is not just academically promising but also clinically relevant. The interdisciplinary team searches, screens, and evaluates hundreds of high-potential biomarkers a year, selecting the most promising. SkylineDx then partners with the inventor and potentially licenses the related intellectual property, allowing it to develop and commercialize the biomarker. The company forms strong partnerships with technology transfer offices from hospitals and academia. SkylineDx structures its R&D around dedicated disease programs, specifically dermatology, hematology, and inflammatory diseases. Within these programs, biomarkers are optimized and their performance verified, followed by a controlled design and development process in which both analytical and clinical validation are tested. When the biomarker, device, and generated data pass regulatory requirements, the result is branded and launched as a commercial test to serve a clinical solution. A major milestone for the company has been the development and recognition of its Merlin CP-GEP test for cutaneous melanoma. SkylineDx announced that CP-GEP (Merlin CP-GEP) is now recognized by the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as a predictive GEP test that may be used in select cutaneous melanoma patients to assess metastatic risk. The company also announced that Merlin CP-GEP was granted FDA Breakthrough Device Designation, building on the NCCN recognition in cutaneous melanoma. These developments position SkylineDx as a company seeking to bring gene-expression profiling into routine clinical decision-making in oncology. SkylineDx emphasizes a collaborative and science-driven culture. Its team is described as driven by scientific and data research in molecular diagnostics, with a collaborative spirit and growth mindset. The company highlights open communication, diversity, and a sense of community, using the hashtag #playtogethertowin. While the company is disease-agnostic in principle, its commercial and clinical focus has been sharpest in dermatology and oncology, particularly through the Merlin test family.

• SkylineDx announces that CP-GEP (Merlin CP-GEP) is recognized by the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as a predictive GEP test that may be used in select cutaneous melanoma patients to assess metastatic risk.

• SkylineDx’s Merlin CP-GEP is granted FDA Breakthrough Device Designation, building on NCCN recognition in cutaneous melanoma.

A molecular diagnostics company bridging academically discovered biomarkers and commercially available diagnostic assays, with a disease-agnostic but focused approach to personalized treatment decisions.

• Merlin CP-GEP

  A predictive gene-expression profile (GEP) test for cutaneous melanoma, recognized by NCCN Guidelines® as a test that may be used in select cutaneous melanoma patients to assess metastatic risk, and granted FDA Breakthrough Device Designation.

• Unconfirmed

  Reported2021.02.18

  SkylineDx receives ISO 13485:2016 certification[6]SkylineDx获得ISO 13485:2016认证prnewswire.com

  SkylineDx announced that it received an ISO 13485:2016 Quality Management System certificate from BSI Netherlands after a successful audit in November 2020.

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1. 1SkylineDx | We care about the people we serveskylinedx.com
2. 2Company - SkylineDxskylinedx.com
3. 3Innovation Pipeline - SkylineDxskylinedx.com
4. 4Team - SkylineDxskylinedx.com
5. 5SkylineDx (Netherlands) - Wikidatawikidata.org
6. 6SkylineDx获得ISO 13485:2016认证prnewswire.com