By Aaron Krol
April 20, 2016 | Four years ago, Greg Sommer and Ulrich Schaff spun out a company from work they had started as staff scientists at Sandia National Laboratories, trying to create a portable, multi-use diagnostic device. Their prototype machine, which they called SpinDx, featured exchangeable disks etched with microfluidic channels. By spinning the disks on a small motor, Schaff and Sommer found that they could separate out cell components from raw samples, like blood draws, through centrifugal motion, while mixing in the reagents or antibodies needed for particular tests.
Today, their company, Sandstone Diagnostics, is nearing an FDA decision on its first product based on the SpinDx technology. This instrument, Trak, is a simplified version of SpinDx designed as an at-home test for male infertility. The plan to release Trak into this surprisingly sparse market won Sandstone the top prize last month at the second annual Swimming with the Sharks competition at the Molecular Medicine Tri Conference in San Francisco, judged by a panel of venture capitalists and executives in the healthcare industry.
“I think it’s a testament to what we’re building here,” says Sommer, now the CEO of Sandstone. “What we showed was that this is a technology and a fit for consumer healthcare that very few others have been able to tap into.”
Sommer and his colleagues see Trak as both an important proof-of-concept for their technology, and a worthwhile venture in its own right, replacing time-consuming and sometimes embarrassing visits to fertility specialists with a test that users can take on their own. “We have a pretty rich IP portfolio and pipeline here that we’ve built the company on, and we want to use male infertility as our first foray into consumer healthcare,” Sommer says. “The technology fits. Semen analysis and sperm cell counting was one of the more straightforward types of testing we could do.”
Unlike the immunoassays that Sommer and Schaff (now Chief Technology Officer) worked on at Sandia, which among other things could have acted as field tests for viral infections, the Trak test does not require any reagents or antibodies. This was an important consideration as the team set out to create a useful consumer product. The trained laboratory professionals at Sandia, who have critical responsibilities in national defense and need systems to track outbreaks and bioterrorism agents, might want a device like SpinDx to run a variety of complex tests in field situations, but in the home testing market, ease of use has to be the first priority.
This was the line of thinking that led Sandstone to invent a male infertility test. The centrifugal motion inside the Trak device separates sperm cells out from a semen sample, forming a cell column. The results can simply be read visually, as the cells stack up against a marked channel, a lot like a thermometer.
As uncomplicated as this sounds, it was still a feat of precision engineering to make Trak run with high accuracy, without demanding any complex user intervention. For instance, Sandstone had to refine the device to precisely control the amount of sample that enters the spin step. “We’ve tried to take out as many steps that could lead to user error as possible,” says Sommer. “You don’t want to rely on people having to do precise pipetting or any kind of home chemistry. It has to be true sample-to-answer.”
Last year, Sandstone enrolled over 200 users for a trial to show that Trak is not only accurate, but also reliable in the hands of untrained customers. The data from that trial have already been submitted to the FDA, which is expected to make a decision on the device this summer. If Trak is cleared, Sandstone will start selling the product direct-to-consumer before the end of the year.
While Sommer says his company still plans to revisit the more advanced capabilities of the original SpinDx prototypes, for now, his team has seized whole-heartedly on their chosen market, which they feel is badly underserved. Sandstone has already released a Trak app with health and lifestyle questions to offer advice on improving male fertility scores, as well as an educational website called dontcookyourballs.com, which aims to tackle the sensitive subject of fertility with a light-hearted, approachable tone.
“This is a topic that is very private and intimate for couples to go through,” says Sommer. “Most things in the fertility space are focused on women… but men are half the cases of infertility.”