FDA News

FDA grants breakthrough device designation to cancer-detecting blood test

The FDA granted the PapGene liquid biopsy test breakthrough device designation for the detection of cancer among people aged older than 65 years, according to the manufacturer.

The PapGene test is a multianalyte test that uses circulating tumor DNA and protein biomarkers to detect cancer among average-risk, asymptomatic elderly individuals. FDA granted this designation based on data showing the test’s ability to detect ovarian and pancreatic cancer.

“We are excited to work with FDA to deliver a test that, if approved, will detect multiple cancers from a simple blood draw,” Howard B. Kaufman, MBA, CEO of PapGene, said in a press release. “Most cancers can be cured by surgery alone if detected in their early and localized stages. This is the first step toward our vision of making pan-cancer detection a reality for patients and dramatically improving cancer survival rates.”

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

In a retrospective study published in Science, a similar assay detected eight types of cancer with a median sensitivity of 70%.

“We applaud the FDA’s decision to address the substantial unmet need for more efficient and effective tools for the detection of cancer,” Nickolas Papadopoulos, PhD, director of Ludwig Center for Cancer Genetics and Therapeutics at Johns Hopkins Medicine, said in the release. “PapGene has developed substantial expertise in liquid biopsy and cancer detection through their work running thousands of cancer research samples in their [Clinical Laboratory Improvement Amendments] lab. PapGene now starts the journey of demonstrating both the safety and effectiveness of the test so more people can be cured of cancer.”

The FDA granted the PapGene liquid biopsy test breakthrough device designation for the detection of cancer among people aged older than 65 years, according to the manufacturer.

The PapGene test is a multianalyte test that uses circulating tumor DNA and protein biomarkers to detect cancer among average-risk, asymptomatic elderly individuals. FDA granted this designation based on data showing the test’s ability to detect ovarian and pancreatic cancer.

“We are excited to work with FDA to deliver a test that, if approved, will detect multiple cancers from a simple blood draw,” Howard B. Kaufman, MBA, CEO of PapGene, said in a press release. “Most cancers can be cured by surgery alone if detected in their early and localized stages. This is the first step toward our vision of making pan-cancer detection a reality for patients and dramatically improving cancer survival rates.”

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

In a retrospective study published in Science, a similar assay detected eight types of cancer with a median sensitivity of 70%.

“We applaud the FDA’s decision to address the substantial unmet need for more efficient and effective tools for the detection of cancer,” Nickolas Papadopoulos, PhD, director of Ludwig Center for Cancer Genetics and Therapeutics at Johns Hopkins Medicine, said in the release. “PapGene has developed substantial expertise in liquid biopsy and cancer detection through their work running thousands of cancer research samples in their [Clinical Laboratory Improvement Amendments] lab. PapGene now starts the journey of demonstrating both the safety and effectiveness of the test so more people can be cured of cancer.”