SkylineDx develops scientifically robust and clinically relevant molecular diagnostic tests to address unmet medical needs in various diseases. Their tests analyze a patient’s unique gene expression to support care providers and patients in treatment decision-making. The company focuses on bridging the gap between biomarker discovery and commercially available diagnostic assays through strategic collaborations.
Funding
Funding not disclosed
NLFounders
Product
Problem
Many patients with progressive diseases like cancer and inflammatory conditions face challenges in receiving timely and accurate molecular diagnostic tests. This can lead to delayed treatment decisions and suboptimal patient outcomes. The process of translating biomarker discoveries into commercially viable diagnostic assays is complex and time-consuming.
Solution
SkylineDx develops and commercializes molecular diagnostic tests that address unmet medical needs in oncology and inflammatory diseases. The company's approach involves a systematic evaluation of potential biomarkers through its STRIX program, followed by rigorous R&D and clinical validation. This process bridges the gap between academic biomarker discovery and the creation of clinically relevant, commercially available diagnostic assays. By analyzing gene expression profiles, SkylineDx provides insights into disease characteristics, enabling more informed treatment decisions for both patients and healthcare providers. The company's commitment to quality is underscored by its ISO 13485 certification and the development of assays like the Merlin™ test for melanoma and SKY92 for multiple myeloma.
Target Audience
The primary target audience includes oncologists, dermatologists, hematologists, and other medical specialists who require advanced molecular diagnostics to guide patient treatment strategies. Researchers and academic institutions involved in biomarker discovery are also key stakeholders.
Features
- STRIX (Systematic, Translational R&D Workflow, building on Integrated Expertise) program for initial biomarker evaluation and selection.
- Dedicated R&D programs: Falcon (Dermato-Oncology), Panthera (Hemato-Oncology), and Delphia (Infectious and Inflammatory Diseases).
- Merlin™ test: A gene expression profiling (GEP) assay utilizing the CP-GEP algorithm to assess melanoma patients' risk of nodal metastasis, potentially avoiding sentinel lymph node biopsy.
- SKY92 test: A GEP assay analyzing 92 genes in malignant plasma cells to determine the aggressiveness and prognosis of multiple myeloma.
- ISO 13485:2016 certified quality management system for medical devices.
- CAP and CLIA certified clinical laboratory in San Diego, USA.
- Collaborative partnerships with academic institutions (e.g., Mayo Clinic, Erasmus MC, Imperial College London) for assay development and validation.
- Development of value dossiers for reimbursement and guideline inclusion.