I caught up with Greg Sommer, the Founder and CEO of Sandstone Diagnostics at the recent Personalized Medicine World Conference 2015 in Mountain View, California. Sandstone’s first product is a male fertility tracker aptly named Trak. It is a consumer-facing, over-the-counter, male fertility test kit that couples can use to both screen and monitor key male fertility parameters at home as opposed to having to go to a doctor’s office for a semen analysis.

Greg says the company invented the device to allow men to do sperm counts in the comfort and privacy of your home. He went on to say that,

“Today, most men aren’t getting tested until the couple is pretty far along in their fertility journey, if they get tested at all. We want to lower the barriers, help men get tested in a much easier and simpler way, and then take steps to improve their fertility and their health in order to improve the chances of getting pregnant.”

 

A mini-centrifuge for sperm counts at home

Sandstone Diagnostic's Trak (Male Fertility Tracker)
Sandstone Diagnostic’s Trak (Male Fertility Tracker)

The device consists of a battery-powered mini-centrifuge, a collection cup, a dropper, and disposable, single-use test cartridges. The man collects the sample in the cup and then uses the dropper to load it into the cartridge. The cartridge is then placed in the centrifuge which begins to spin for a pre-determined amount of time when the lid is closed (if the lid is accidentally opened too soon, an error occurs and the process must be repeated). By spinning the sample, sperm cells (which are the most dense components of semen) sediment out of the sample and collect in the outer region of the test cartridge. The size of the sperm cell pellet correlates with the concentration of cells.

Greg says they have done validation studies that show the results from Trak are “as accurate as those you get in a doctor’s office,” but there are no peer-reviewed studies published to date.

 

Wait, there’s more…

Trak mobile app
The Trak mobile app

Trak’s mobile app helps men monitor their key fertility stats over time and correlate changes in sperm count to certain lifestyle changes known to impact sperm (diet, hot tubbing, exercise). Men can then take steps to improve their health and chances of conception. According to the Sandstone website, “Trak is more than just a test kit…it’s a comprehensive solution to help you conceive.”

To learn more about male fertility and take an interactive “risk assessment” quiz, check out their companion website, “Don’t Cook Your Balls.” The quiz takes about 10 minutes to complete and, per Greg, “provides comprehensive feedback on areas of a man’s life that may contribute to fertility issues.”

 

It’s not yet on the market, but…

The company is currently taking the product thru FDA 510K process. Once approved, they plan to sell the product over-the-counter, direct-to-consumers. They haven’t finalized the pricing yet, but anticipate it will be similar to “what is going on, on the female side in terms of ovulation monitoring and predictor kits.” They have other products in the work including a test for sperm motility that will use the same mini-centrifuge but will require a different cartridge.

 

Video interview with the CEO:

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