ContraVac's post-vasectomy home sperm test
This article was originally published in Clinica
Executive Summary
SpermCheck Vasectomy, a diagnostic which confirms men's post-vasectomy sterility, has been granted 510(k) clearance from the US FDA. The device, manufactured by Charlottesville, Virginia-based ContraVac, will enable men to test their fertility status at home, in a procedure the company describes as similar to a home pregnancy test for women. It is the first at-home diagnostic to receive FDA approval for sperm testing after vasectomy. SpermCheck Vasectomy is designed to improve the compliance rate for post-vasectomy sterility testing. Around 500,000 vasectomies are performed each year in the US and most patients are asked to undergo two post-vasectomy sperm tests. Currently, nearly 35% of patients never return to the doctor's surgery or lab for their first test and over 70% do not return for their second. The diagnostic will be launched in the US in mid-2008.