The Lead Detect Prize invites innovators to harness new methods and emerging technologies and turn scientific possibilities into tangible advancements for public health. While electrochemical sensing is the current standard for blood lead testing, other types of technologies and techniques may offer new possibilities. GlucoSentient, one of five Phase 1 winners that advanced to Phase 2 of the Lead Detect Prize, is adapting a glucose meter platform and using a DNAzyme sensor to detect lead in a blood sample.
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 Tian Lan, Lead Scientist at GlucoSentient, about the misconceptions regarding lead detection, designing the right point-of-care systems, and the next steps for his team’s technology.
How did you find out about the Lead Detect Prize? What motivated you to enter?
It was the president of our company, GlucoSentient, who found out about the Lead Detect Prize, and then he forwarded it to me. He thought it was a perfect fit for the company, and I agreed.
Our company is focused on medical diagnostics, so we do blood testing, urine testing, and other types of more human-related testing. We thought the Lead Detect Prize was a good fit because the technology was originally intended for heavy metal detection, including lead, but we did not actually move into the blood detection of lead, because at the time, we believed there was no demand for a new type of test for blood lead level.
What do you find most inspiring or challenging about lead detection?
The baseline technology for lead detection has been the same for a while. There are some new technologies that have come up, but it is mostly the same. I think the most challenging part for the point-of-care detection of blood lead is to develop a complete package and to get very accurate results.
Tell us about the technology or solution you are working on. How will it improve lead detection?
Our technology is a sensing platform that is based on DNAzyme, which is a piece of DNA that can sense the presence of very low amounts of lead and generate glucose as the signal. This signal can be directly detected by existing glucose meters, but we also modify it so we can have better sensitivity. We are combining a low-cost sensor system with DNAzyme, which has very high sensitivity and selectivity for lead.
The computer platform is designed to be the best-designed point-of-care system for use by humans to do diagnostic tests. That is a grand claim to make, but I am confident. We hope by combining those two, we can deliver an accurate lead blood test at the point of care with convenience and low cost.
What have you learned about lead detection in children since starting the challenge?
Seeking new technology for point-of-care blood lead detection is somewhat surprising to me. Following the removal of lead products from the consumer market, we are seeing a significant decrease in lead in the environment. That’s why we thought the need for lead detection was reducing and a lot of work will shift back to the central labs.
After being involved in the Lead Detect Prize for the last few months, we actually found out that this need did not die down; it shifted to a need for a point-of-care device, instead of a centralized test. This is an important development in lead detection and will help us move forward.
What has been the most valuable part of the accelerator so far?
As a scientist, I look at this from the scientific or R&D point of view. The educational webinars from the experts in the field were very valuable for us. The advice from the public health nurse and the regulatory experts was also helpful.
The advice from the public nurse provided us direction and guidance on how we should design our product. Our current product is designed for untrained personnel or a home user, so it may not be suitable for a point-of-care type of device that is for a medical professional. The nurse’s advice helped us realize that there may be a need to make two types of devices, one for point-of-care use and one for home use.
Through this, we realized we may have to go out and then talk to public health nurses locally, and have design meetings with them to help us. We’d want to know how to design our technology to satisfy their needs.
The regulatory experts provided help that was very technical. They gave us guidance on what we needed to do, how we needed to do it efficiently, and how to clear the roadblocks to bring the product to market. Generally, we have an idea of how to proceed, but they just gave us all the details and the supporting documents to do it.
Additionally, the clinical samples provided by the partners were also useful and important.
What role do laboratory standards play in innovations like this? How do they enable innovation?
Laboratory standards provide the standard of innovation and new types of testing principles, which, especially for our company and technology, were essential. So unlike traditional lead detection that uses electrochemical detection, we use DNAzyme, which we are able to put on a new platform for this type of application. I think it’s very important to use lab standards to certify our results so that we make sure that our results are comparable to other measurements obtained by other methods.
What are your biggest development priorities moving forward?
With the Phase 2 support, we validate our assay pretty well. Next is to integrate into our prototype system. Because it’s a new type of assay to be integrated on our current platform, we may undergo significant engineering tasks to adapt it. We’ll also be including on-device samples pre-treatment to reduce the complexity of the assay or the test, and also to improve the accuracy. That will be the primary focus early on in the development.
And then as it moves on, the focus will slowly shift into making sure the overall test is easy to use. It will consider human factor engineering and user interface engineering; finally, it will shift into validating the performance of the whole system.
In a shorter time frame, the most important one will be integrating the assay into the cartridge and then developing a functional prototype.
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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