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Wire · opportunities

SkylineDx Named “Diagnostics Company of the Year” by BioTech Breakthrough for a ...

5 November 2026 · By · Wire by Fusion42

Published

5 November 2026

Topic

opportunities

◆ Sectors

Biotech

◆ Geography

United States

◆ Source

Read at citybiz.co →

◆ Verified

Fusion42 · 5 November 2026 · Fusion42 review

SkylineDx has been named Diagnostics Company of the Year for the second consecutive year by BioTech Breakthrough, recognised for its molecular diagnostic tests for oncology, including the Merlin CP-GEP test for melanoma which received FDA Breakthrough Device Designation and NCCN guideline recognition in 2026.

This Wire brief sits within Fusion42's coverage of Biotech.

◆ ◆ The Wire takeaway

You can gain early access to a market just recognised by FDA breakthrough status and major clinical guidelines. Your oncology molecular diagnostics product can now lean on Merlin’s dual regulatory and clinical validation momentum to open clinician doors.

◆ Coverage

1 source · 5 Nov 2026

◆ Related on Wire

◆ Topics

Biotechmolecular-diagnosticsoncologyregulatory-approvalFDA-breakthrough-deviceclinical-guidelines