A new home test kit called SpermCheck Vasectomy, based on a protein discovered at the University of Virginia (UVA) Health System, marks the launch of a product line that could revolutionize the way men monitor their reproductive status. Based on antibodies that bind to SP-10, a protein discovered in the laboratory of John C. Herr, PhD, SpermCheck Vasectomy is the only FDA-approved immunodiagnostic test for monitoring sperm after vasectomy.

The device looks and functions much like a home pregnancy test. By measuring SP-10, which is present at constant levels in each sperm head, it enables men to quickly and accurately monitor sterility after a vasectomy. Monitoring is important because sperm can remain in the male reproductive tract for weeks or months after the procedure. To avoid unexpected pregnancies, vasectomized men must practice birth control until their sperm count falls below fertility levels. Currently, 1.5 million men worldwide have vasectomies each year, but many skip one or both of the recommended follow-up tests that determine if the operation was successful. The at-home privacy, convenience, and affordability of SpermCheck Vasectomy will boost post-operative monitoring and allow couples to accurately determine when contraception methods are no longer needed, Herr says. A second product, SpermCheck Fertility, has concluded clinical trials and is awaiting FDA approval, with a tentative launch date later this year. A third product, SpermCheck Contraception, is being used in a multi-center, NIH-funded study that is evaluating the effectiveness of a new contraceptive drug for men. The kit will be marketed as a companion product whenever the first FDA-approved male contraceptive drug or device becomes available.

The product line is a model of translational research. In the early 1980s, Herr and colleagues were looking for a sperm-specific biomarker when they discovered the gene ACRV1. From there, they identified a new protein, SP-10, that was encoded by ACRV-1 and proved useful in sperm detection and quantification. Between 1984 and 2008, group members published 22 articles about their research in medical and scientific journals. As work progressed in the laboratory, Herr met with the UVA Patent Foundation, which helped him to apply for and obtain four U.S. patents related to SP-10 and SpermCheck technology. The Patent Foundation later licensed the exclusive rights to SpermCheck-related antigens, antibody reagents, and methods of use to ContraVac, a Charlottesville-based biotechnology firm founded by Herr in 1998. ContraVac worked with Princeton BioMeditech Corporation (PBM) to develop prototypes, followed by clinical and consumer trials. "SpermCheck is a great example of how long-term, interconnected collaborations can move an idea out from the research bench and into the hands of physicians and consumers," Herr says.

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Conceive Online