FDA Grants Breakthrough Device Designation for Cancer Detection Liquid Biopsy

PapGene, Inc, has announced their cancer detection test has received Breakthrough Device designation from the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA).

The PapGene test is a multianalyte test that uses a combination of circulating tumor DNA (ctDNA) and protein biomarkers to detect the presence of cancer in average-risk, asymptomatic individuals over the age of 65 years old. The FDA granted Breakthrough Device designation based on the test’s ability to detect both ovarian and pancreatic cancer.

PapGene was formed in 2014 to commercialize advanced cancer detection technology developed by the founders at Johns Hopkins Kimmel Cancer Center. In a retrospective study published in Science earlier this year, a similar assay reliably detected eight types of cancer with a median of sensitivity of 70%. Importantly, the study focused on detecting localized cancers early, before metastases have occurred and 5-year survival rates lower. PapGene is currently developing a clinical version of the test that is robust, reproducible, and cost-effective for detecting cancer earlier than current standard-of-care methods.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.




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