Couples will soon have a new tool in diagnosing male infertility - without the expense and inconvenience associated with a trip to a specialist's office.
SpermCheck Fertility is a new, over-the-counter product that allows men to check their fertility status in the comfort and privacy of their own homes. Based on technology developed at the University of Virginia , this immunodiagnostic test received clearance from the U.S. Food and Drug Administration on May 7.
Developed by U.Va. inventor John C. Herr and colleagues, SpermCheck Fertility uses a platform similar to a home pregnancy test to measure a man's sperm count. In seven minutes, the test measures the amount of sperm-specific biomarker SP-10, discovered in Herr's lab, present in a semen sample to determine whether a man's sperm count falls above or below fertile levels, in accordance with World Health Organization standards.
"The FDA clearance of SpermCheck Fertility allows this rapid, easy-to-use, cost-effective test to reach the drug store shelf, where it will help couples decide if low sperm concentrations might be at the heart of difficulties conceiving," said Herr, director of U.Va.'s Center for Research in Contraceptive and Reproductive Health.
According to the American Society for Reproductive Medicine, one in seven couples has trouble conceiving, with the man contributing some or all of the cause of infertility in 40 percent of these cases.
"By identifying male infertility early in a couple's decision-making process, SpermCheck Fertility will likely reduce unnecessary infertility testing of women, an important consideration in this cost-conscious era," added Herr, who is also a professor in U.Va.'s Department of Cell Biology.
Herr has received four issued U.S. patents on the SpermCheck technology, which he patented through the U.Va. Patent Foundation. The Patent Foundation licensed the patented technology to U.Va. biotechnology start-up ContraVac Inc., founded by Herr, to commercialize the discoveries and bring associated products to the public.
"Dr. Herr and his colleagues have truly broken ground with the SpermCheck technology," said Miette H. Michie, executive director and CEO of the U.Va. Patent Foundation. "We congratulate ContraVac on its success in developing this technology and look forward to seeing the impact of this notable U.Va. invention on male fertility monitoring."
"A vital part of our mission at the University of Virginia is to move new knowledge to the public, where it can help people," said Thomas C. Skalak, the University's vice president for research. "Dr. Herr's creativity and ability to move an idea to the marketplace have the potential to truly change the world. He personifies the personal initiative, scientific curiosity and innovation required to make a positive economic and social impact."
ContraVac plans to make SpermCheck Fertility commercially available on its Web site, www.contravac.com, beginning next month and at pharmacies later this year.
"Female home fertility tests have been available for 40 years, but until now there has not been an accurate and inexpensive home male fertility test," said Edward J. Leary, ContraVac's president and chief financial officer. "As a result of Dr. Herr's research and the development efforts of our manufacturing partner, Princeton BioMeditech Corporation, ContraVac is excited to bring this long anticipated home male fertility test to market."
SpermCheck Fertility is one of a family of products being developed by ContraVac. SpermCheck Vasectomy received FDA clearance in 2008 for post-vasectomy sterility monitoring and is currently being sold by physicians to their patients throughout the U.S. and directly from ContraVac's Web site.
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