PapGene Blood-Based Cancer Test Receives Breakthrough Device Designation by FDA.


US Food and Drug Administration has granted PapGene Blood-Based Cancer Test Breakthrough Device designation. The basis for this designation is the ability of the test to detect ovarian cancer as well as pancreatic cancer. The test utilizes a combination of protein biomarkers and circulating tumor DNA. This combination can detect cancer in an asymptomatic individual of 65+ age, who are at average risk.

The program, Breakthrough Devices, is a part of the “Expedited Access Pathway” program by FDA. The program enables timely access to technologies and devices which can proffer more effective treatment of life-threatening diseases which may not exist otherwise.

PapGene has a lot of expertise in liquid biopsy and cancer detection, according to Nickolas Papadopoulos, the director of Ludwig Center for Cancer Genetics and Therapeutics at Johns Hopkins University. The firm has done extensive research including thousands of cancer research samples in their CLIA labs.

The test devised is based on a similar test called CancerSeek which was made by researchers from JHU. The test could detect localized cancers in areas like the liver, stomach, esophagus, ovaries, lungs, colorectum, breasts and pancreas, before the occurrence of metastasis. The founders of PapGene are from JHU, who made this firm to commercialize cancer detection technology. A clinical version of the test is being sought after by the firm that is cost-effective and reproducible for the detection of cancer way before than the other standard methods.

The CEO of PapGene, Howard Kaufman, claims this test to be the first step towards making the pan-cancer detection a possible reality for cancer patients. Its application will substantially better cancer survival rates.