In 2021, CDC issued new guidance for blood lead testing; this updated guidance has intensified the urgent need for improved technology that can provide clear, actionable results at the new, lower reference value. Meridian Bioscience, one of five Phase 1 winners that advanced to Phase 2 of the Lead Detect Prize, uses electrochemical sensors to detect lead — and is seizing the opportunity to improve its existing point-of-care solution by incorporating stakeholder input.
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 David Beliveau-Viel, Manager of R&D at Meridian Bioscience, about the presence of lead in our environment and food, the value of point-of-care testing, and the importance of idea-sharing in the lead poisoning prevention community.
How did you find out about the Lead Detect Prize? What motivated you to enter?
We learned about the prize through a LEPAC (Lead Exposure and Prevention Advisory Committee) meeting. Those meetings run on a regular basis. They’re really an important nexus for the blood lead testing and lead poisoning prevention community in the United States. We’ve been following them for years because, as the manufacturer of the only FDA-cleared point-of-care blood lead testing device, we’ve been around for a while and know the community. When we learned that there was going to be a challenge around lead detection, we started to talk about it within the company and considered participating. We saw it as a significant new opportunity because there really hasn’t been anything like this for decades in the lead testing space.
It is an opportunity to really meet and engage with the lead poisoning prevention community — not just with the usual stakeholders like the major regulatory agencies and public health experts that frequent the LEPAC meetings, but with a broader set of individuals and organizations; namely promising new entrants in this space, people with potentially new ideas, new questions, and new points of view. We felt that this challenge could really begin a new chapter in the blood lead testing space and wanted to be a part of it.
What do you find most inspiring or challenging about lead detection?
What’s inspiring about lead detection itself is that by detecting lead in a child, you can halt ongoing exposure. That’s really the most important part; by halting exposure, you can prevent further harm to that child. Blood lead detection really is the only way to do that, because we know from literature that developmental impairment can occur at blood lead concentrations that are well below those that generate visible symptoms. It is a silent poison at chronic and low levels, so you must test every possible source of lead in a child’s environment. It can be in the soil, in old, flaking paint, in water pipes, in toys, in spices. Recently we’ve seen apple puree and cinnamon recalls because of lead contamination.
In an ideal world, we’d be able to eliminate all sources of lead. Until that time comes, the approach of testing children allows you to catch that silent exposure and act on it. Not only can you go to the child’s environment and remove the source of exposure, but if the source of exposure is in the consumer supply, then you can also stop exposure for every other child.
That’s really inspiring to us. It’s the type of solution that prevents harm nearly as directly as you can. Now, the challenge is to make that accessible to as many people as possible, because we know from published literature, from the NHANES survey and public data that the average blood lead levels have heavily decreased over the last few decades, but that does not reflect individual exposure in children. We can applaud the lowering of the average blood lead levels, while still working to test every child.
You have to test and find those individuals that could have exposure, and that’s why it is essential to make this technology accessible especially to those most at risk. It is challenging because you also must take in the requirements, the needs, and the desires from a broad swath of stakeholders, like public health experts, regulatory agencies, lab technicians, managers, and others we met through the accelerator. Through hearing from many of them, we know the challenge is to distill that into a single product that can then be cleared through the regulatory agencies.
Tell us about the technology or solution you are working on. How will it improve lead detection?
Our technology uses a simple electrochemical test. We’ve been around for a while, and we’ve listened to and engaged with many users and stakeholders. To us as a team, the biggest improvement that our solution is going to bring to these stakeholders is modern features that they’ve expected and we’ve refined from all these discussions. Those features will streamline their user experience — from the untrained users all the way up to public health authorities — to make it accessible for all, and just that much easier to adopt testing at the point of care.
What have you learned about lead detection in children since starting the challenge?
One of the most fascinating lessons is really the diversity of points of view in the lead detection community. It was truly highlighted through the accelerator. You have four modules, panelists, discussions during and afterward, and this diversity of points of view on what is the optimal solution to reach the most children. The challenge organizers themselves shared valuable target metrics for performance and for functionality.
We heard from public health experts, such as ML Tanner and Gail Gettens, on how important it is for them to make blood lead results more streamlined and robust and reporting from the states to public health authorities easier for everyone. We also heard from Dr. Paradis, who’s a medical director and practicing primary care pediatrician, about her concerns on getting test results quickly at the point of care when there’s a child and patient in the office; her insight was invaluable. And through all that, with the diversity in points of view, all stakeholders were united in their assessment that they needed reliable point-of-care testing to make sure every child is tested.
What has been the most valuable part of the accelerator so far?
The way we see it, the accelerator is not just valuable for us, it’s valuable for the community at large. We got to hear ideas, comments, and questions from the entrants, the panelists, the organizers, the judges. This prize provided an open forum and format for those discussions and questions. And again, all these stakeholders have different experiences.
The most valuable part was that it enabled everyone to see each other’s perspectives and put themselves in each other’s shoes. By sharing ideas, everyone planted seeds in each other’s minds, and we’re certain they will grow and develop new perspectives and possibilities for lead testing in the future. We feel the accelerator expanded the brain trust of thinkers around lead testing and we’re sure it’ll pay dividends.
What role do laboratory standards play in innovations like this? How do they enable innovation?
They play an essential role because they establish a shared vocabulary and a shared understanding on how to evaluate a design. It becomes so much easier to talk about an idea, a solution, an innovation, and how to test it when everybody at the table reads the same book and speaks the same language. With that, we can focus our discussions on the ideas themselves.
One example that was encountered in the accelerator was how to define the limit of detection and limit of quantification. With a lab standard to support, instead of debating definitions, we can focus on evaluating our solution given the guidance that’s provided and that’s accepted. Then we can ensure the quality of our solution and of the innovation that’s delivered.
Sometimes developers discover a technology or an idea that shows promise in the lab, and excitement and interest builds up around it. But after some more testing, they find that maybe the science isn’t quite there yet, or it only works in the lab, and not in the intended point-of-care setting. Laboratory standards establish shared benchmarks that everyone can use when evaluating solutions and ensures better quality of those designs and innovations overall.
What are your biggest development priorities moving forward?
Our goal is and has always been to bring accurate blood testing to everyone who needs it, within the U.S. and around the world. So our current priority for development is to build partnerships with clinicians who test children on a regular basis to ensure that our solution is reliable and easy to use for them in the real world with real patients.
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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