New and novel detection solutions can come from adjacent and analogous spaces. Could environmental testing approaches be applied to blood lead detection in point-of-care settings? OndaVia, one of five Phase 1 winners that advanced to Phase 2 of the Lead Detect Prize, is applying its spectroscopy and colorimetry techniques — initially used to detect lead in water samples — to detect the presence of lead in blood.
Through August 2024, the Phase 2 teams participated in a virtual accelerator designed to help them advance their point-of-care blood lead detection solutions. The goal of the multiphase Lead Detect Prize is to enhance the detection of low levels of lead exposure through blood tests administered at the point of care.
We spoke with Merwan Benhabib, Vice President of Engineering at OndaVia, and CEO Mark Peterman about translating their industrial solutions for clinical contexts, closing the technology gap, and collaborating with experts during the accelerator.
How did you find out about the Lead Detect Prize? What motivated you to enter?
Merwan: We learned about the Lead Detect Prize through connections with public health advocates and industry partners working on addressing the danger of lead poisoning. What motivated us to enter is the critical need for a more reliable solution, given the recall and performance issue with the CLIA-waived test that exists. We already had a proven technology that works effectively in detecting lead in water samples with a product ready for industrial applications. The real challenge and opportunity for us in this competition is adapting that technology to work with blood samples, maintaining the same level of performance and cost-effectiveness of our technology. By entering the Lead Detect Prize, we saw a chance to apply our expertise in an entirely new and impactful context and help to protect vulnerable populations like children from lead poisoning.
What do you find most inspiring or challenging about lead detection?
Merwan: Lead detection is inspiring because it directly addresses one of the most preventable causes of childhood development issues and lifelong health problems. It’s challenging, however, due to the complexity of reliably detecting levels of lead in blood with samples, with simple point-of-care methods. Achieving high sensitivity and accuracy while keeping the solution accessible, cost effective, and easy to use for healthcare professionals without specialized training is no small feat. It’s something that we’ve worked on for over 14 years. So adapting it to the medical device field is the novel part that is a new challenge for us. But the impact of lead detection, in particular, is a good entry point to bringing our technology to the medical device world.
Mark: Initially, we were very focused on drinking water applications that would impact human health, but much of the business has been pulled in the direction of industrial process monitoring for multiple reasons. And the opportunity to get back to applications that directly impact human health is quite exciting and fun.
Tell us about the technology or solution you are working on. How will it improve lead detection?
Merwan: Our solution leverages something called surface-enhanced Raman spectroscopy. It’s a spectroscopy technique: You get a fingerprint of what you’re looking for, and combine it with colorimetry or colorimetric dyes or something that changes color when in contact with the lead, and another analytical method for quantification called standard addition method. This technology allows us to be highly sensitive to trace amounts of lead in blood, achieving lower detection than the current standard CLIA-waived test. At the same time, it remains simple to use for users and stays quite accurate and reliable. Furthermore, our approach addresses issues like matrix interferences that often plague lead detection techniques. Our solution also integrates automated data reporting to a relevant agency, further simplifying the compliance process for clinics and healthcare professionals.
What have you learned about lead detection in children since starting the challenge?
Merwan: Since starting the challenge, we’ve learned not only about the critical importance of detecting lead exposure in children, but also how wide the technology gap is with existing products. Many current solutions fail to deliver both the ease of use and reliability necessary for effective point-of-care testing, leading to significant recalls and performance issues. The failure rate in creating a simple yet reliable test is much higher than we initially expected. The realization pushed us to think outside the box. We understood that a more traditional approach to solving this problem would not work. We began cross-pollinating innovations that have proven successful in other fields and diving into our own successes in the test and measurement in industrial applications that haven’t been applied to the point-of-care testing domain. That allowed us to develop a novel solution, maintaining high performance while remaining user friendly and cost effective.
Mark: Additionally, having been focused on water, the challenge of doing this in a blood matrix or in a biological matrix has, in some parts, been simpler and some parts been more difficult. It’s been an interesting problem. In addition, understanding the sampling methods, the requirements in the clinic, the biomedical side, and the healthcare side for sample collection and how things are currently done — we’ve been drinking from a fire hose of information having spent so many years dealing with water in the water industry. Healthcare is a very different application, in a surprising number of ways.
What has been the most valuable part of the accelerator so far?
Merwan: What I found the most valuable was the access to expertise and resources that have helped us finetune our solution to meet the real-world needs. Collaboration with industry experts and public health officials has given us deeper insights both on the regulatory landscape and the practical challenges that nurses and healthcare professionals face when conducting those kinds of tests in children. So the feedback has been instrumental in shaping our development strategy and also ensuring that we would propose something that has a meaningful impact.
Mark: Because the accelerator is driving the predefined market from a business side, someone else is saying, “There is a market need and we’d love you to solve this problem. Here are some parameters around which you need to figure it out.” At the same time, there’s a bit of a push to solve the problem, putting a timeframe on it, putting limits on it, putting some information in place, and forcing you to think about it within a framework. That’s been useful. Having an application that’s in a different market, it’s easy enough to sit around and say, “Well, we think we could do that,” but never do the hard work to actually make it happen. And the accelerator gives the framework to make sure we’re doing the right pieces first.
What role do laboratory standards play in innovations like this? How do they enable innovation?
Merwan: They are critical. Especially for Phase 2, determining whether we can hit them or not is essential to validating. CLSI, in particular, has been essential in validating the accuracy, precision, reproducibility of, at least at an early stage, the technology. So it provided the framework to allow a new technology to be rigorously validated and tested. It will open doors to further refining and ensuring that we can meet regulatory requirements and that we can perform consistently.
Mark: We’ve learned over the years that it’s often very easy to do things in the lab during the research phase. It’s very easy to hit targets and standards, and until you start putting real-world samples in real-world situations through a method, you never really know if it’s going to work. There are two types of standards: One is laboratory standards in samples with known levels that can be run through a device and real-world materials. And the other is the standard bodies that define methods. Until you bring those two together and push yourself against them, and you encounter either one of those standards, you really don’t know if you’re going to be successful.
What are your biggest development priorities moving forward?
Merwan: In the short term, we need to finalize our instrument prototype using those standards. It has a great performance metric. We need to further develop both the consumable and the instrument to conduct field tests with healthcare providers, particularly in clinics with high-risk populations, further set ourselves up for trials and clinical trials, and down the road obtain a CLIA waiver. Even further down the road, we aim to expand the platform’s capabilities beyond lead detection. Leveraging the versatility of our platform and our service technology, we can develop a multiplexed diagnostic tool that can target other harmful substances and biomarkers. Lead is the right anolyte to get us started with developing a point-of-care approach.
Mark: We also have development to do on the business side. We have to put the right framework in place, the right people in place, and the right funding in place to be able to take something from a prototype into something that can actually be tested and trialed and then scaled from there. So there’s a lot of work to do, but we’re excited because we’ve got some great, fantastic early data and excited to take that next step.
Looking ahead: Demo Day at the Milken Institute of Public Health in Washington, D.C.
On October 24, the Lead Detect Prize will host a Demo Day at the Milken Institute School of Public Health at George Washington University. During the event, the five Phase 2 teams will showcase their lead detection solutions, and the winners of the $850,000 Phase 2 prize pool will be announced.
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