PapGene, Inc., a leader in the field of liquid biopsy with a focus on the development of high-performance tests to detect cancer, 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 multi-analyte 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 Designation based on the test’s ability to detect both ovarian and pancreatic cancer, advancing the FDA’s goal to help give patients timely access to medical devices that provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions by expediting their development, assessment and review.
“We are excited to work with FDA to deliver a test, that if approved, will detect multiple cancers from a simple blood draw. 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,” said Howard Kaufman, Chief Executive Officer of PapGene.
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 percent. Importantly, the study focused on detecting localized cancers early, before metastases have occurred and five-year survival rates plummet. 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.
“We applaud the FDA’s decision to address the substantial unmet need for more efficient and effective tools for the detection of cancer,” said Nickolas Papadopoulos, Ph.D., Director, Ludwig Center for Cancer Genetics and Therapeutics at Johns Hopkins Medicine. “PapGene has developed substantial expertise in liquid biopsy and cancer detection through their work running thousands of cancer research samples in their CLIA lab. PapGene now starts the journey of demonstrating both the safety and effectiveness of the test so more people can be cured of cancer.”