Former Sandia researchers Greg Sommer and Ulrich Schaff have created a new, portable diagnostic kit that allows men to self-test for sperm quality with a few drops of semen. The device, based on technology they helped create at Sandia, provides results in five minutes.
“It allows men to test and track their fertility from the comfort and privacy of their own homes,” Sommer said. “It’s a portable, easy-to-use diagnostic system with the accuracy of a clinical lab test.”
The researchers co-founded a startup company, Sandstone Diagnostics Inc., in 2012 to develop and market the monitoring kit. The testing device, dubbed TrakFertility, could be on the market by early 2015, after the company receives regulatory approval from the U.S. Food and Drug Administration.
“We believe there’s a lot of pent-up demand for a product like this,” Sommer said.
The researchers developed TrakFertility after working on a project at Sandia’s lab site in California to create an instrument that would allow first responders to rapidly detect toxins, radiation or other biological agents in emergency situations.
That device, called the SpinDX, is billed by Sandia as a medical diagnostic “lab-on-a-disk” that can process tissue samples in the field for protein and white blood cells in just 10 minutes.
Ulrich and Sommer realized the technology had many potential commercial applications, so they licensed it from Sandia to further develop and market it for male fertility testing.
The partners envision the monitoring kit as more than just a single test. Rather, TrakFertility would provide an ongoing home diagnostic for men to regularly monitor semen quality as they take steps to improve fertility.
“It would be like using a scale to follow weight, only in this case, men would track changes in their fertility,” Sommer said.
In that sense, education is a central part of Sandstone’s commercial strategy. The company’s website, trakfertility.com, teaches men about the causes of infertility and about lifestyle changes they can make to improve potential for conception.
For example, it tells men to avoid heat, such as not spending excessive time in hot tubs and saunas because sperm are sensitive and need to remain 4 degrees cooler than body temperature to avoid lowering sperm count and motility.
It also calls for reducing stress, overcoming obesity and eating better to eliminate toxins in the body, all of which can contribute to low fertility.
In addition, Sandstone is developing a mobile app to help men track and analyze the results of their tests and communicate about them with their doctors. The goal is to broaden today’s focus on women’s fertility to include the other side of the equation, Sommer said.
“We want to help people conceive in a way never done before,” he said. “The market today is completely focused on females to monitor hormones, temperatures and so forth for peak fertility windows each month. But one of every five men has low-sperm counts that can impair conception.”
Half of all fertility issues involve the male partner, and 30 percent of the time, the male is the main cause, according to their guide to reproductive and sexual health, which the company plans to include with all TrakFertility kits.
Investors believe there will be a large, growing market for Sandstone’s products.
“Just one word: ‘Viagra,'” said John Chavez, president of the New Mexico Angels. “There was no market for that 10 years ago. Think about it.”
Sandstone appealed this week to the Angels – a group of about 70 high-wealth New Mexicans who jointly invest in startup companies – to put money into Sandstone.
The company has raised about $750,000 to date from individuals and from the National Institutes of Health. It’s now raising a $1.5 million round of venture capital to take TrakFertility to market by next year.
“The New Mexico Angels will be participating in the round, although we don’t know how much we’ll contribute yet,” Chavez said. “Sandstone is addressing a truly untapped market need. That adds a lot of value to their product.”
The company expects to make the TrakFertility kit available online in early 2015 through the company website. The kit is expected to retail at prices comparable to women’s fertility products.
The company is unlikely to pursue mass marketing. Rather it will seek to partner with established medical companies for direct sale to consumers.