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FDA Grants Breakthrough Device Designation for PapGene Blood-Based Cancer Test

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.

The FDA instituted the Breakthrough Devices Program in 2016 as part of its "Expedited Access Pathway" (EAP) program. The process helps patients have more timely access to devices and technology that provide more effective treatment or diagnosis for life-threatening diseases that do not otherwise exist. The Breakthrough Devices Program expands on the EAP program by making future 510(k) approvals eligible as well as Premarket Approval applications and de novo device submissions.

The firm's assay is based on a similar test —called CancerSeek— developed by researchers at Johns Hopkins University. A study published in Science in January focused on the assay's ability to detect localized cancers —including areas such as the ovaries, liver, stomach, pancreas, esophagus, colorectum, lungs, and breast— early, before metastasis has occurred and five-year survival rates drop.

"This is the first step toward our vision of making pan-cancer detection a reality for patients and dramatically improving cancer survival rates," PapGene CEO Howard Kaufman said in a statement.

Formed in 2014 to commercialize cancer detection technology by its founders at JHU, PapGene is developing a clinical version of the assay that is durable, cost-effective, and reproducible for detecting cancer earlier than standard methods, the firm said.   

"PapGene has developed substantial expertise in liquid biopsy and cancer detection through their work running thousands of cancer research samples in their CLIA lab," Nickolas Papadopoulos, director of the Ludwig Center for Cancer Genetics and Therapeutics at JHU, said in a statement.