FDA Grants Breakthrough Device Designation to Blood Test for Detecting Cancer


Recently, FDA (Food & Drug Authority) of USA granted the PapGene liquid biopsy the Breakthrough Device Designation for detecting cancer amongst individuals who were aged above 65 years.

The PapGene blood test is a specialized multi-analyte test that makes use of the DNA of the circulating tumor along with protein biomarkers for detecting cancer amongst the average-risk, asymptomatic aged individuals. Recently, FDA granted this blood test the prestigious Breakthrough Device Designation on the basis of the data which showed the ability of the test towards detecting pancreatic and ovarian cancer.

Howard B. Kaufman –the CEO of PapGene stated in a press release that the company is excited to work in collaboration with FDA towards delivering the test that, once approved, can help in detecting multiple cancers from the simplest drawing of the blood sample.

Most of the cancers can be cured easily through surgery alone once they are detected in the early & localized stages. This turns out to be the first step towards the company’s vision of creating a pan-cancer method of easy detection a reality for the patients all over the world. This can dramatically help in improving the overall cancer survival rates globally.

PapGene is currently in the state of developing the clinical version the specialized liquid biopsy test that could help in detecting cancer quite earlier than the current standard methods of detection. The FDA’s decision is given much applause as it is aimed towards addressing the unmet needs of the highly effective tools for detecting cancer. PapGene has been successful in developing substantial expertise in the field of cancer detection through the respective liquid biopsy test that has been achieved through several research samples of different types of cancer.