This startup is developing a test to detect early-stage ovarian cancer

When treating cancer, the earliest possible detection often yields the greatest chance of successful treatment.

Statistics indicate that’s especially true of ovarian cancer, which causes more deaths than any other cancer of the female reproductive system. But there’s a problem.
“There is not a good way to detect early-stage ovarian cancer,” said Howie Kaufman. “It presents in later stages when it’s more difficult to treat successfully.”

As CEO of PapGene, Kaufman is leading an effort to commercialize a test that is targeting the earliest stage of the cancer.
The basis is cervical fluid that is obtained through a routine Pap smear, which tests for early-stage cervical cancer. A big discovery that led to the test came when researchers at Johns Hopkins found DNA that indicated ovarian and endometrial cancers on cells in the cervix.
Using technology developed under the direction of cancer genomics pioneer Bert Vogelstein at the Ludwig Center in Johns Hopkins’ Kimmel Cancer Center, the test looks at the DNA of exfoliated cells for mutations that are indicative of cancer, Kaufman said. Additional technology developed at the Cancer Center reduces machine error so the test can find rare mutations.
Vogelstein is among five scientific cofounders of the company who have been conducting research on cancer genomics for decades. The opportunity to commercialize the PapGene test is the result of a culmination of applying the two technologies to the Pap test, as well as the DNA testing technology becoming more affordable.
The startup, which operates out of a retrofitted lab at Johns Hopkins’ FastForward incubator in the Stieff Silver building, recently received a fast-tracked Small Business Innovation Research (SBIR) grant from the National Cancer Institute of the National Institutes of Health to continue developing the tests. The grant is typically awarded in two phases. However, since the grant is a more competitive Fast-Track award, the Phase I and II applications are reviewed together, which is designed to eliminate funding gaps between phases.
The company will initially receive $297,000 to test the accuracy of the test. If that phase is successful, the company will receive another $2 million for clinical trials and begin regulatory approval. The clinical trials will include patients donating samples, as opposed to the pre-existing ones that the company has used to date, Kaufman said.