SkylineDx

SkylineDx develops molecular diagnostic tests that read a patient's gene expression to help doctors choose treatment. It focuses on cancer, where patients with the same diagnosis often respond differently to the same therapy.

The company works with academic medical centres in the United States and Europe to turn biomarkers found in research into commercial assays, then signs partners to sell them more widely.

What SkylineDx offers

• Gene signature tests — assays that profile a patient's disease to support faster diagnosis, choosing who needs a procedure, or finding likely responders to therapy.
• Merlin CP-GEP — a test for cutaneous melanoma that assesses metastatic risk and appears in NCCN guidelines for selected patients.
• Assay development — moving academic biomarker discoveries into tests that clinics can buy.
• Market access work — effort on reimbursement so tests reach real-world patients.

Who it works with

Physicians, cancer patients and patient advocates, plus academic centres and commercial partners in the United States and Europe.

Key facts

• Certification: ISO 13485:2016 for developing, making and selling in vitro diagnostic devices in genetic profiling
• Experience: more than ten years in molecular diagnostics
• Recognition: the FDA has granted Breakthrough Device Designation to Merlin CP-GEP