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NCI Awards PapGene Grant to Develop Noninvasive Bladder Cancer Test

NEW YORK (GenomeWeb) – Molecular diagnostics developer PapGene announced today that it has received a $2.2 million Fast-Track Small Business Innovation Research (SBIR) grant from the National Cancer Institute (NCI) to commercialize a urine-based test for the surveillance of recurrent bladder cancer.

The test is designed to detect cancer-associated DNA mutations, combining massively parallel sequencing with proprietary error-reducing technology developed at the Ludwig Center at the Johns Hopkins Kimmel Cancer Center. The company also recently received an SBIR grant to develop an ovarian and endometrial cancer test based on the same technology.

Work on the bladder cancer test will occur in two phases. The first, which is being funded with $299,824 from the NCI, will involve demonstrating the test's accuracy and clinical validity. In the second phase, PapGene will receive roughly $1.9 million from the NCI to show the test's clinical utility and submit it for regulatory approval.

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