PapGene, Inc., a molecular diagnostic company, 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 (NIH) 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.
PapGene is a Baltimore-based molecular diagnostic company dedicated to advancing the early detection of curable cancers.