ContraVac Receives FDA Approval For Post-Vasectomy Home Sperm Test

Main Category: Fertility
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 05 Mar 2008 - 1:00 PDT

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ContraVac, Inc., a biotechnology company with reproductive and fertility focus, announces the U.S. Food and Drug Administration (FDA) has recently approved SpermCheck Vasectomy®, a simple diagnostic which confirms men's post-vasectomy sterility. The device will enable men to test their post-vasectomy fertility status at home rather than requiring the patient to return to the physician's office or a laboratory.

SpermCheck Vasectomy is an easy-to-use diagnostic device similar to a home pregnancy test for women. It is the first test with the sensitivity and specificity required to detect low numbers of sperm and the first at-home diagnostic to receive FDA approval for sperm testing after vasectomy. Physicians will be able to provide SpermCheck Vasectomy to their patients following their vasectomy or men can purchase SpermCheck Vasectomy directly from ContraVac.

SpermCheck Vasectomy will be commercially available in the U.S. as soon as Summer 2008. ContraVac will be presenting SpermCheck Vasectomy at the American Urological Association Annual Meeting in May 2008.

Ed Leary, President of ContraVac said: "The convenience and privacy SpermCheck Vasectomy provides is anticipated to improve the compliance rate for post-vasectomy sperm testing, resulting in fewer unwanted pregnancies and providing greater peace of mind." There are approximately 500,000 vasectomies performed each year and most physicians require two post-vasectomy sperm tests. The inconvenience and indignity associated with returning to the physician's office or laboratory to supply semen samples has created an environment where nearly 35% of patients never return for their first sperm test and over 70% do not return for their second sperm test.

SpermCheck Vasectomy utilizes technology discovered by John C. Herr Ph.D., Director of the University of Virginia Center for Research in Contraceptive and Reproductive Health and the founder of ContraVac. According to Dr. Herr, "The SpermCheck Vasectomy Test is the result of many years of basic research, clinical chemistry know-how, customer ease-of-use trials and an appreciation for the home-use market. Our objective was to convert the genetic technology into a device which performs at sensitivities necessary to achieve our unique FDA approval status."

SpermCheck Vasectomy