Merlin CP-GEP Earns FDA Breakthrough Designation, QuidelOrtho Shares Jump 3.8%
QDEL•SkylineDx’s Merlin CP-GEP prognostic test for stage II colon cancer received FDA Breakthrough Device Designation on July 1, accelerating its US review and commercialization timeline. QuidelOrtho shares rallied 3.8% in response, reflecting investors' expectations for near-term revenue from the test's launch.
1. FDA Grants Breakthrough Device Designation
On July 1, FDA awarded Breakthrough Device Designation to SkylineDx’s Merlin CP-GEP, a molecular prognostic test targeting stage II colon cancer patients. The designation is intended to expedite regulatory review, offer priority access to FDA guidance, and accelerate potential market launch in the US.
2. Investor Response and Commercial Outlook
QuidelOrtho shares rose 3.8% on the news as analysts project accelerated commercial roll-out could drive early‐stage revenue growth. Management now plans to finalize clinical validation and submit a full premarket approval application, targeting initial US launch within 12–18 months.
