FDA Grants Breakthrough Designation for Liquid Biopsy Test to Detect Cancers

The U.S. Food and Drug Administration granted breakthrough-therapy designation to PapGene liquid biopsy test for the detection of cancer among people >65 years old. PapGene is a multianalyte test that uses circulating tumor DNA and protein biomarkers to detect cancer in average risk, asymptomatic individuals. 

The decision was based on test’s ability to detect both ovarian and pancreatic cancer. In a retrospective study published in Science, a similar assay reliably detected eight types of cancer with a median of sensitivity of 70%. 

https://t.co/lvnkbmkooa PapGene, Inc. Receives FDA Breakthrough Device Designation for Liquid Biopsy Test that Detects Multiple Cancers…

— OBR Oncology (@OBRtweets) August 9, 2018

PapGene is currently developing a clinical version of their liquid biopsy test that could detect cancer earlier than current standard-of-care methods. 

Read about a simple blood test for melanoma detection. 

Screening blood for Zika is timely, yet costly. 

Source: PapGene, Inc.