Ask Dave Bergstein about the next big thing in diagnostics and his eyes light up. The Zoíray Technologies Inc. founder and CEO runs startup that’s developing a next-generation multiplexed immunoassay platform Bergstein thinks will become the new state-of-the-art standard for studying proteins.
That’s because, unlike competitors’ devices, the Zoíray machine doesn’t rely on “labels,” or the fluorescent or chemiluminescent dyes used to mark proteins. Instead, the device uses an optical scanner to detect the presence of proteins, eliminating the need for the dyes altogether. That’s an advantage because the dyes, which require careful calibration and storage can add variability to the process and add an additional step to every operation.
MassDevice, which shares office space with Bergstein, sat down for a chat about what sets Zoíray apart from its myriad competitors, why he’s willing to risk going up against some of the largest players in the industry and how he came to be included in MassMEDIC’s 11th Annual Medtech Investors Conference.
MassDevice: How did you go from being an electrical engineer to developing a diagnostic device and starting your own company?
Dave Bergstein: I’ve always been interested in entrepreneurship. I’ve had an interest in optics and among all the different applications, I found myself drawn to medical, the idea that those applications can help people.
I went to the University of Delaware for electrical engineering and worked as a power electronics engineer for a lighting control company called Lutron Electronics.
I came to Boston after that because I wanted to get into more advanced technologies. This was in late 2000. I wanted to be in Boston, I had friends here, and once I got here I figured it was a good opportunity to go to school. I wound up studying photonics — optics — at Boston University and got my PhD in Jan. 2007.
In 2008 I started Zoíray, because I was very excited about the technologies we were working on at BU and I thought I was the best person to champion that and forward it as a company. Years earlier we had talked to some of the bigger companies in the space, but I felt we had a vision that we should pursue ourselves and show them the true value of this technology.
PerkinElmer sat down with us in about 2004 and they felt that we had a long way to go. They weren’t ready to buy in with a license deal. I was just a grad student, I would have been happy for PerkinElmer to take it at that point, but when they didn’t see the value that I saw, I guess that’s part of what gave me the passion to start this business. That combined with my interest in entrepreneurship — I was actually taking classes at the BU School of Management’s MBA program as well.
Tell us about the Zoíray device. What is it and how is it different from your competitors’ offerings?
Dave Bergstein: The technology is a platform for miniaturizing and integrating many protein tests onto a single, disposable chip. A key enabling factor is our optical detection. That’s the core tech. It’s better because we can detect protein-binding interactions without the need for secondary labels, be they fluorescent or chemiluminescent. These are the mainstays of the industry. It’s a $4 billion market, detecting proteins for diagnostics, and I believe strongly that part of the barrier to combining many tests on a small, simple disposable chip is the labels, the fact that the existing technology must incorporate these fluorescent or chemiluminescent dyes.
Our device works via a pretty simple principle, and that’s interference with light. It’s kind of like a soap bubble, where you get reflections from the top surface of the soapy film and the back surface of that film. The reflected light interferes constructively at some wavelengths and non-constructively at other wavelengths and produces the colors you see in the soap bubble. By measuring that reflection and its wavelengths on the sample, we determine how much protein is on the surface. We accurately measure the mass of the protein layer using this interference.
People have used this idea of interference dating back about 20 years, but we do it better. We have a proprietary setup that achieves high sensitivity and we can do it across the whole surface at once, enabling potentially thousands of parallel tests to be run together.
I like to break our competitors into three areas: There’s the existing market, the $4 billion space for these types of protein tests. They all fall under the word “immunoassay.” It’s led by Abbott, Siemens and Beckman Coulter. We compete against them with these advanced tools that combine many tests onto one chip. There’s a vast need as biotech continues to flood us with biomarkers that show benefit. It becomes a real bottleneck for physicians to run all these tests. Basically, the research is showing us the value and benefit of so many different protein biomarkers, and the cost of running these tests as traditional immunoassays becomes a real bottleneck to improved care.
The second group is those who are trying to miniaturize and integrate many tests onto one small disposable chip or assay. Our key competitors there are Luminex and Bio-Rad. Luminex is still mostly in the research space, while Bio-Rad bridges between research and healthcare. These all use labels, they still rely on fluorescent dye or chemiluminescent dye to detect the result.
The last group would be innovators and visionaries like us, who believe that you don’t need to rely on these dyes. We compete most directly with Quadraspec and Forté Bio. They’re not in healthcare yet, but their technology does compete with us. They haven’t miniaturized onto a small chip yet, but can we expect they’ll go there.
GE Healthcare is also in the label-free space, with the acquisition of Biacore. They’re label-free, but their platform is large, complex and not amenable to a clinical setting. Their market has been research labs and pharma.
We have two target markets. The one we’re focusing on is healthcare, the in vitro diagnostics market with tests that would combine many protein marker tests onto one small, disposable chip. To get there we can sell product today into research labs and pharma companies, who can benefit from the ability to run many tests in parallel, label-free, for advancing biological research and developing drugs. So that’s our second market. But our focus is ultimately to reach healthcare.
MassDevice: You recently closed your first sales of the device. What’s next for Zoíray?
DB: Our first sale was to the NEIDL, the National Emerging Infectious Diseases Laboratories, which is so controversial it hasn’t even opened yet. So the instrument is sitting on the BU medical campus being used by infectious disease researchers. Ultimately they’ll get it into the NEIDL and use it for its intended purposes.
The second one is slotted for a government agency I’m not allowed to reveal, for research use.
The third went to Tel Aviv University, to its Center for Nanoscience and Nanotech, for immunology research.
These were really prototype sales to gain feedback and early cash. We intend in both marketplaces to work though a partner. We’d like to partner with somebody in the lab supply space to reach the research customers in labs and pharma and we’d like to work with an in vitro diagnostic healthcare partner to reach the diagnostics market.
We’re talking to several potential partners in the lab supply space and are gearing up to find partners in the healthcare space.
MassDevice: How did you wind up at the MassMEDIC Investors Conference?
DB: A friend mentioned the conference to me and connected us with MassMEDIC. We’re looking to raise money, preferably in the Boston area, and it seemed like a good fit for us.
MassDevice: In a nutshell, what’s your pitch for the event?
DB: We’re going to focus on the work that we’re doing in collaboration with the BU Alzheimer’s Disease Center. We were funded by the NIH’s National Institute on Aging to develop a multi-variate test for Alzheimer’s disease that would incorporate dozens of protein markers for the disease and help monitor disease progression and connect the right patient with the right treatment at the right time.
Our technology is an excellent fit for this application, given our ability to combine many tests onto one small disposable chip and given the simplicity of our technique and its amenability to the clinical environment. Equally as important is the quantitative nature of our measurements, since they’re very repeatable and in the end we really know exactly how much protein marker is bound to every spot that we’re evaluating.
MassDevice: What’s it like operating a small startup in this economic climate?
DB: Since we’ve been supported by sales and SBIR grants, it’s not something that has yet influenced us so directly. Going forward, obviously, we hope that the climate improves as we look toward raising capital.
MassDevice: What do you think the next big thing in diagnostics will be?
DB: I think whether it be from us or others, there’s a real value to evaluating large numbers of biomarkers in a single test. I honestly believe this is going to come to pass, one way or another. It’s going to have to. The pathology of disease is so rarely going to be elucidated by one marker. Disease is often the result of a complex network of interacting biochemical reactions and if we really want to understand and diagnose as best we can we need to start looking at the whole cast of biomarkers, not just a single marker.