NEW YORK (GenomeWeb) – Startup PapGene announced today that it has received Breakthrough Device designation from the US Food and Drug Administration for its blood-based cancer diagnostic assay.

The FDA granted the status based on the assay's ability to detect both ovarian and pancreatic cancer. PapGene's assay uses a combination of circulating tumor DNA and protein biomarkers to detect cancers in average-risk, asymptomatic individuals over the age of 65.

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