A New Spin on Centrifugal Technology

How Sandstone Diagnostics Is Advancing At-Home & Point-of-Care Testing

The centrifuge isn’t a particularly scintillating piece of technology by 2018 standards. The vial-spinning contraption has been in existence since the 1400s (when a hand-crank variety was used to separate milk) and has remained relatively unaltered for decades.

Sandstone Diagnostics has given this classic device a new spin, opening up brand new opportunities for at home and point-of-care testing. Initially, their patented centrifugal technology is being used to allow men to test their fertility at home, for an affordable cost.

But after launching their male fertility line just over a year ago, Sandstone’s CEO Karen Drexler started to see a much bigger use case emerge. This centrifugal technology can be applied to a wide range of other medical tests, like testosterone levels, that benefit from being separated at the point of care.

We caught up with Karen to dig into how their patented technology is being used to improve men’s fertility and overall health, the larger need for their technology in healthcare and the future of at-home and point-of-care testing.

StartUp Health: What’s the backstory of Sandstone Diagnostics, and how did you find yourself involved in male fertility?

Karen Drexler: I joined Sandstone Diagnostics a couple of years after Greg Sommer, Ulrich Schaff and Sara Naab founded the company. I was brought in on the cap table as a founder but the company really started when Greg and Ulrich were working on developing portable technology at Sandia National Labs in Livermore, California. This was back 10 years ago, right around the time when there were a series of Anthrax scares. The government was interested from a biodefense standpoint in being able to have something simple, portable and could test basically anything, anywhere. So, they developed this platform that used microfluidic chips and a centrifuge in order to be able to do testing of things like soil, or crops, or people, whatever might be needed.

The background was great, because they were able to develop a centrifuge that is super easy to use. It doesn’t even have an on button. It has a magnetic closure that starts automatically when a sample is placed in there. The whole system is designed to be very easy and easily deployable.

At that point, the co-founders decided to license out their own technology. They started out by licensing out 10 patents on which they were the inventors. They spent about a year looking at different applications of the technology. They got some NIH funding in the area of sepsis testing, specifically neonatal sepsis. When they went out and talked with investors, however, they were told that they not start the company around the sepsis space. There had been a lot of companies around that time that had started and failed in that area.

The third founder, Sara Naab, who comes from more of an non-profit background and an entrepreneurial family, was pregnant at the time and got interested in the fertility area. She quickly realized that the female fertility side of the business was way oversaturated but the male fertility side was wide open. They decided then to see if their centrifuge technology could be applied to separating out sperm from semen and being able to provide a very easy at-home male fertility test, and that was the direction that they went in. When they went out for their first funding, I joined the company as an angel investor and board member in 2014.

StartUp Health: What has the last four years looked like at Sandstone?

Karen: The technology has been in development for the past four years, as the technology and testing kit had to go through full product development, clinical trials, and FDA approval, and that took until the end of 2016. The Trak Male Fertility Testing System was introduced just over a year ago.

It is now direct-to-consumer through our own website, through Amazon and through the FSA (flexible spending account) store. By this time I had joined as CEO, right before the product launch. I helped get the product in the market and then figure out what else we could apply our technology to.

StartUp Health: What excited you about their technology so much that you would join as CEO?

Karen: As it happened, about 10 years ago I actually advised another company in the male fertility space. They were unable to bring their product to market. They had a really interesting technology created by a talented group of guys, one who was a physician out of Stanford. There was additional technology and work that was needed in 2008, 2009 time frame when economic conditions were such that getting anything funded was virtually impossible. The company ended up shutting down for lack of funding. But that’s how Sandstone found me. They ended up talking with someone who had been the manufacturing guy for that earlier company, who recommended that they talk to me, because I already knew the space. I already understood the industry, but there was a hole. I understood, because of the work I have done previously, but there was some large strategic interest in the space. So all of that made it very compelling for me.

StartUp Health: You saw not only the hole, but you saw there was real opportunity there.

Karen: I did. I really liked the team and the product was already FDA approved, so it seemed like a good time to bring it to market it.

StartUp Health: How has it been testing the markets reception to male fertility at home? Biggest challenges you might have faced along the way?

Karen: Testing is really the right wording. We didn’t do a whole blown launch, we really treated it as a test market. We had some basic things that we were trying to figure out. For one, when we talk about sperm, if you tried to do email blasts, or use different kind of marketing, you often end up in spam. We had a fair amount of work to do right off the bat, figuring out how we could talk about the product in a way that it could be recognized.

Also, if you talk about it generally as fertility, it gets lost in all the female fertility products. A big part of our first years work was just messaging, and honestly, figuring out are we marketing to men or are we marketing to women. It turns out that we’ve been most effective in actually marketing to women, although men are the main purchasers. Women are the ones who are researching fertility online, but most women are reluctant to buy a male fertility test without the male being engaged. The woman is doing the research, and says this is something I’d really like us to try, hands over the information to the man, and that’s why 80% of our actual purchasers are male.

There is also a lot of education involved, for both men and women, who tend to think that fertility is a female problem. Even though half of the fertility cases are male. We decided some time ago that we were going to look for the right partners that were already in front of our customer base and would have their attention for the education piece. Whether it’s a company in the female fertility space that already has a captive audience and you provide more context, or a brand that is is building up their presence directly focused on the millennial male is another opportunity. We are moving along quite well with some of those partnerships and I’m hoping we can announce some of them pretty soon.

StartUp Health: How can male fertility be a window into overall men’s health?

Karen: It turns out that the male reproductive system is heavily influenced by lifestyle. Much more so than the female reproductive system. For women if they’re having trouble getting pregnant, and if they are obese, losing weight certainly will help. There’s not a lot else they can do. The majority of men can see significant improvement in infertility by changing their lifestyle. And in the same vein, early signs of disease which might not cause men to experience symptoms still can have a huge impact on the male reproductive system.

As an example, the leading cancer in men, 15 to 35, is testicular cancer. The early signs of testicular cancer is a drop in sperm production. Around a third of men with testicular cancer are actually diagnosed because they’re having trouble with conception.

Urologists are starting to talk about how testing at home and regular monitoring would result in men going in for a medical evaluation, because a drop in sperm count could be an early warning sign of testicular cancer. And like most cancers, the earlier you catch it, the better the outcome.

In addition, obesity is a big contributor for men, and obesity has always all these comorbidities with diabetes and cardiovascular diseases, so that’s all something that you might see changes relevant to these kinds of conditions.

StartUp Health: We love what you guys are doing and how you are thinking differently about men’s health. From the beginning you’ve known that Sandstone’s centrifuge is an invention that was novel and useful in a variety of ways. What pivoted in your mind about seeing it more in depth or more as a core product?

Karen: The evolution was actually a pretty natural one. We love the men’s health space and we want to bring other products, besides the Trak Male Fertility System, to market in the men’s health space. One of the products that we have on our road map is a blood testosterone test. Fingerstick blood, and that would be useful in the physician’s office as well as for home, when men are put on testosterone therapy.

The team has a lot of experience developing blood tests and other tests, but blood tests using our platform. And the first thing that happens when we want to test something in the blood, using the centrifuge, is we separate out the blood cells. We get plasma. Most tests are run on plasma.

As we were working on developing the next test on our road map, we were talking with diagnostic companies, and what we started hearing from companies was an interest in just that first step of our technology — how we can separate blood from plasma, which will be used as the origin source for us to do other tests, like the testosterone, or PSA, or other things.

We also started hearing from companies, especially if they’re testing DNA, where the DNA in the blood cells can contaminate the DNA that is in the plasma, it makes testing harder. They are interested in just the plasma separation part of our analytical platform.

If we can make the centrifuge a product all by itself, let’s take a little detour, let’s turn it into a product. Let’s participate in this exciting area of molecular diagnostics. And what we’re developing is still going to support our future product.

StartUp Health: Walk us through an example of a person having this technology available at home for testing things like testosterone, and why it’s so important to have it at home, or a doctor’s office, versus the lab down the street.

Karen: The first embodiment of this would most likely happen in a doctor’s office, not at home. So you go to a doctor, and right now they draw your blood into tubes. The tubes are sent to a lab. When they get to the lab, they put it into a big centrifuge and they separate out the plasma so they can test for various things. While that blood is being stored in the blood tube and transmitted to the lab, there’s a certain amount of decay that happens. By actually taking the blood right at the point of draw and using our technology to separate it out into cells versus plasma, we can stabilize the plasma and improve the quality of the sample for the lab testing.

StartUp Health: It improves the test which is good, but what’s the selling point for the doctor?

Karen: For the doctor, if they have a phlebotomist in their office, it’s a matter of 5 seconds for somebody to put a blood sample in a centrifuge and close the lid. They would mail in our tests vs mailing in tubes to a lab. We realize it is very important to minimize the workload on the doctor. Especially for some of these molecular or self treat diagnostics, because DNA quality degrades in shipping, and then there’s a certain amount of rejection with the sample. And if the lab needs to get back to the doctor, who then needs to contact the patient to try to schedule another test, that’s a workload for the doctor that he or she is not paid for.

StartUp Health: Centrifuges have existed for a long time. You have made this simpler and cheaper. Otherwise doctors would have these in their offices already.

Karen: There are not a lot of centrifuges that are used in doctors offices — although there are a few. Dermatologists, for example, use centrifuges to prepare plasma rich platelets for cosmetic treatments.

The bottom line is doctors don’t have centrifuges in their offices because most tests are sent to a central lab. However, they’re looking to improve the quality of their they’re offering, and potentially offer additional tests, based on better sample quality. That’s really the driver here.

We have talked to and are tracking over 200 companies in the point of care testing space. Those systems either need to find a way to deal with the blood, because they are not testing the blood cells, they’re testing and analysing the plasma. As we’re talking to some of these companies that are developing point-of-care tests, the opportunity to have a very easy one step ahead of their test if we give them a nice clean plasma input, can also help and enable growth in the point of care testing space.

StartUp Health: You mentioned before that Sandstone’s centrifuge is incredibly simple, like a magnet closure, anyone can do it. So, besides it being created to be incredibly user-friendly and simple, what sets it apart from buying a standard centrifuge and putting it into a doctor’s office?

Karen: The main difference from most centrifuges is they tend to be kind of clunky, you have a bunch of tubes in there and it’s sometimes hard to balance samples. They also require a trained expert who understands how to use them and knows how to set up the sample. Once it is set up, it takes anywhere from 15 to 30 minutes to do the separation. That’s efficient if you’ve got a whole bunch of tubes there. But if you got one patient, one sample, you want to get it into a point-of-care test, for example, we can separate out a whole tube of blood in about a minute and a half. The sample is placed right in the center of the centrifuge, so we can generate very high output with a very simple device. It’s already approved for home use by lay users, so it doesn’t take any training.

StartUp Health: What would be the most clear at-home use for this?

Karen: The sperm testing being done currently is an ideal at home use. In the future as I mentioned, adding in the end to end test capabilities for something like testosterone is another clear home use case, for men that are on testosterone therapy. In terms of just separating out plasma, that’s less clear, people are not doing a bunch of blood testing at home. However there are a series of companies that are working on ways to do blood draws without a phlebotomist, and these are meant for at home use, or for physician offices where there isn’t a phlebotomist, or a nursing home.

Currently there are a whole bunch of devices in development for collecting smaller amounts of blood without a trained technician. And we can potentially be a perfect interface for those devices, where you not only collect that sample, but you stabilize it by separating out the blood cells at that time. So we’re talking to a couple of them about partnering as those systems could come to a home user at some point.