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Medical Devices / Submissions and Approvals

Personal Genome Diagnostics Gains CE Mark for Plasma-Based Oncology Test

March 15, 2019

Personal Genome Diagnostics earned the CE Mark for its PGDx elio plasma resolve, an oncology test that broadens genomic testing for European cancer patients.

The test detects single nucleotide variants, amplifications, rearrangements, microsatellite stability and small insertion/deletions in a multi-gene panel in circulating cell-free DNA extracted from plasma samples.

The qualitative in vitro diagnostic test received the FDA’s breakthrough designation in July 2018.

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