The U.S. Food and Drug Administration (FDA) has issued 510(k) clearance for Sandstone Diagnostics’s Trak Male Fertility Testing System.
Trak, which will be available for purchase beginning in October, is an in-home test that allows couples to measure and track sperm count conveniently and privately as they try to conceive. The design uses centrifugal force to isolate and quantify sperm cells using specially designed disposable cartridges. The system includes several disposable test kits for repeat testing.
The device provides semi-quantitative results, classifying sperm counts as “Low”, “Moderate” or “Optimal” based on World Health Organization guidelines and clinical studies that correlate higher sperm counts with faster time to pregnancy. The system pairs with a mobile app (available on Google Play, the Apple App Store and Amazon) to allow men to enter, track and compare their results to population statistics via the cloud-based community of users and clinical databases, and receive personalized feedback on lifestyle and wellness steps that may boost their sperm count.
Data suggest that men contribute to up to half of all infertility cases, but couples currently have very few options for tackling the male half of the conception equation. Today’s standard practice of medical evaluation by clinical semen analysis done in an office setting is generally viewed as an awkward and embarrassing experience for men, which further contributes to low rates of male evaluation and treatment.
“Male infertility is a dramatically under-appreciated condition affecting millions of couples every year,” Greg Sommer, Sandstone CEO, said in a press statement. “Trak is a complete system that not only gives couples the ability to conveniently measure semen quality at home, but also provides digital health tools and population-based data to help men take charge of their reproductive health in a whole new way.”