Illumina Shares Jump 4.58% After Partner’s Test Wins FDA Breakthrough Designation
ILMN•ILMN•ILMN•ILMN•Illumina partner SkylineDx secured FDA Breakthrough Device Designation for its Merlin CP-GEP prognostic test, potentially accelerating priority review and market entry by months. ILMN shares climbed 4.58% on the news, reflecting investor optimism about new high-margin sequencing-based diagnostic applications.
On July 1, the FDA granted Breakthrough Device Designation to SkylineDx’s Merlin CP-GEP assay, a prognostic test that integrates gene expression profiling with clinical parameters. This status provides priority review and interactive feedback from regulators, which can shorten the pathway to approval and accelerate commercial launch.
Illumina shares rose 4.58% following the announcement, driven by expectations that its sequencing platforms will capture additional reagent sales and licensing revenue. Investors view the designation as a catalyst for expanding Illumina’s role in high-value, precision diagnostics markets.
