PapGene, Inc. Awarded Phase II SBIR Contract to Develop Genetic Cytology Test for the Surveillance of Recurring Bladder Cancer

Baltimore, Maryland, 2 September 2017

PapGene, Inc. announced today that it has been awarded a Phase II Small Business Innovation Research (SBIR) Contract from the National Cancer Institute (NCI) of the National Institutes of Health (NIH). The $1.9 million two-year contract will fund the development of a genetic cytology test for the surveillance of recurring bladder cancer. PapGene’s assay achieves sensitivity and specificity through identifying DNA mutations causative of cancer from routinely collected urine samples. PapGene’s test couples massively parallel sequencing (MPS) with a proprietary error-reducing technology resulting in increased sensitivity for detecting somatic mutations.

Phase I work demonstrated analytical validation of the assay using control samples and
demonstrated the clinical validation of the assay using retrospective specimens. Building on
Phase I work, Phase II will demonstrate clinical utility of the test in a prospective patient cohort.
Dr. Isaac Kinde, PapGene’s Chief Scientific Officer and Principle Investigator on the SBIR said,
“Successful completion of Phase I milestones is helping PapGene demonstrate a genetic test
can be effective in improving the diagnosis of recurrent bladder cancer by improving patient
outcomes. We expect this will lead to reducing the utilization of costly, invasive surveillance

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 molecular diagnostic company dedicated to advancing the early detection of curable cancers. The company is developing innovative tests that uncover early-stage cancers from the analysis of easily accessible body fluids. The company’s assays detect cancers while they are still surgically resectable by identifying the presence of genetic defects (acquired mutations) that drive cancer growth.

For more information, please visit

Media Contact:
Howard Kaufman
Chief Executive Officer
PapGene, Inc.

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