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BREAKTHROUGH
SpermCheck Vasectomy is one of several products developed with technology created by John C. Herr, Ph.D., Director of UVA’s Center for Research in Contraceptive and Reproductive Health, and patented and licensed by the UVA Patent Foundation. A key element to this breakthrough, Herr says, were interdisciplinary clinical collaborations with a research team that includes Stuart S. Howards, M.D., Professor of Urology, and Charles J. Flickinger, M.D., Professor Emeritus of Cell Biology. “The SpermCheck Vasectomy test is the result of many years of basic science research coupled with clinical chemistry know-how,” says Herr, a Professor of Cell Biology. “Similar to a home pregnancy test for women, it is the first immunodiagnostic test with the sensitivity and specificity required to detect low numbers of sperm, and it is the first immunodiagnostic test to receive FDA approval for monitoring sperm count after a vasectomy.” Over 17 years, Herr’s lab identified a gene (ACRV1) that encoded a protein (SP-10) that could serve as a sperm-specific biomarker. The SpermCheck Vasectomy device uses monoclonal antibodies that bind specifically to the SP-10 protein to measure the amount in nanograms of SP-10 protein present, which directly corresponds to the number of sperm present. The device enables men to test their post-vasectomy fertility status at home rather than return to their doctor’s office or a laboratory with semen samples, as has traditionally been required to confirm sterility. Among men older than 35, 1 in 6 have had a vasectomy, according to the National Institutes of Health. Approximately 500,000 U.S. men undergo vasectomies each year, making vasectomy the third-most-popular contraceptive option among married couples in the U.S., according to the National Institute of Child Health and Human Development. Vasectomies are not 100 percent effective, and vasectomized men can experience recanalization, or the spontaneous healing or restoration of the vas deferens, resulting in a return to fertility. SpermCheck Vasectomy can be used to monitor and confirm sterility following a vasectomy, alerting couples should fertility become restored. Herr believes the device also could be used to monitor male infertility if male contraceptive pills are successfully developed. Researchers believe the availability of the SpermCheck Vasectomy will have several positive effects. They expect more men will undergo the post-vasectomy sperm test requested by doctors due to the SpermCheck’s convenience, quick results and its planned availability at pharmacies. They also think that the success rate of vasectomies will improve thanks to prompt identification of possible failures and recanalization. An easy-to-use test should also help family-planning programs around the world. “Translational research is essential to bringing the exciting new developments in basic science biomedical research to patients,” Howards says. “The outcome of an intense collaboration between basic science and clinical urology, SpermCheck Vasectomy is an example of translational research 20 years in the making.”
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A post-vasectomy test based on discoveries made at the University of Virginia could soon have a dramatic impact on male contraception in the U.S. and throughout the world. Earlier this year, the U.S. Food and Drug Administration (FDA) approved SpermCheck® Vasectomy, a home test that confirms men’s post-vasectomy sterility.