PapGene, Inc. Awarded NIH Contract for the Surveillance of Recurrent Bladder Cancer

PR Newswire

New test being developed to detect bladder cancer via causative DNA mutations

BALTIMORE, Sept. 27, 2016 /PRNewswire-USNewswire/ — PapGene, Inc., a privately-held company commercializing advanced molecular tests, announced that it was recently awarded a Fast-Track Small Business Innovation Research (SBIR) contract from the National Cancer Institute of the National Institutes of Health to commercialize a test for the surveillance of recurrent bladder cancer.

The funds for this Fast-Track contract will be released in two phases, which together have the potential to provide a total of over $2.2 million in resources to PapGene’s test commercialization efforts. Phase I will provide $299,824 to the company to demonstrate the accuracy of the test and its clinical validity. Upon successful completion of Phase I, Phase II will provide approximately $1.9 million to demonstrate the clinical utility of the test and to launch its regulatory approval process.

“Due to the high rate of recurrence, bladder cancer is one of the most expensive cancers to manage on a per-patient basis,” says Howie Kaufman, CEO of PapGene. “The development of a noninvasive molecular test for recurrent bladder cancer surveillance has transformative potential in improving patient outcomes while decreasing cost of care.”

It is estimated that 76,960 new cases of bladder cancer will occur in 2016. Because of the high recurrence rate, bladder cancer patients require lifelong surveillance with frequent assessment by costly, invasive and painful test modalities. PapGene’s test, which identifies recurrent bladder cancer from routinely collected patient urine specimens, is based on a new approach referred to as “genetic cytology.”

“This award will support a powerful new approach to identify recurrent bladder cancer by the genetic defects that drive their growth,” adds Isaac Kinde, M.D., Ph.D., PapGene’s Chief Scientific Officer.

The PapGene test couples massively parallel sequencing (MPS) with a proprietary error-reducing technology developed in the Ludwig Center at the Johns Hopkins Kimmel Cancer Center.

For additional information on PapGene, please visit its website at

This project has been funded in whole or in part with Federal funds from the National Cancer Institute, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN261201600034C. The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

About PapGene, Inc.
PapGene is a Baltimore-based molecular diagnostic company dedicated to advancing the early detection of curable cancers. The company was founded by five world-renowned experts on the molecular and genetic analysis of human cancer: Bert Vogelstein, M.D., Kenneth W. Kinzler, Ph.D., Luis Diaz, M.D., Nickolas Papadopoulos, Ph.D., and Shibin Zhou, M.D., Ph.D. Their relationships with PapGene have been reviewed and approved by the Johns Hopkins University in accordance with its conflict of interest policies.

SOURCE PapGene, Inc.

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