CLSI is Proud To Support the Lead Detect Prize

The Lead Detect Prize is a US$1 million phased challenge to develop new technologies and solutions for lead detection in children.The challenge is designed and managed by Luminary Labs on behalf of the National Aeronautics and Space Administration (NASA) Tournament Lab and in collaboration with the Centers for Disease Control and Prevention (CDC).

Lead poisoning is a significant public health issue in the US, particularly in low resource communities, and can cause significant developmental delays in children. Today, the primary mechanism for lead detection is a clinical blood sample. There is only one commercially-available US Food and Drug Administration (FDA)-approved point-of-care test and it is often unable to provide clear, actionable results at the new, lower reference value updated in 2021. The Lead Detect challenge is designed to accelerate the development of new methods and alternative next-generation point-of-care tests. "The ideal solutions would be compact, easy to use, and affordable, facilitating expanded childhood lead exposure testing and early intervention," explains the Prize organization.

The phased challenge launched in late 2023, advanced five teams to a second round in March of 2024, and then announced the three finalists that will share the US $850K prize funding just last week at a Demo Day celebration at George Washington University. CLSI was proud to attend and share in the celebrations as an invested supporter providing standards guidance to the competing teams.

Standards play an important role in the acceleration of innovation and development of laboratory testing methods and technologies, as noted by several of the competing teams:

"Laboratory standards give us benchmarks to guide the development of the assay, and metrics to validate the performance of our new test. They tell you what methods already exist, what they’re able to achieve, and what would be an improvement over the current state of the art.”

- Fluorezyme


"[Standards] 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 laboratory 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."

- Meridian Bioscience

“[Standards] set a baseline from which the improvement is needed to really help make these technologies more accessible — not only in communities that have the money and resources available to invest in sending samples to centralized laboratories, but also in communities that lack those resources. The advantage of having laboratory standards is they can define clear metrics and requirements that anyone developing a solution can follow, and these standards can help them reach that goal. They also help in setting a more rigorous process during the product development cycle.”

- SensiLead

CLSI is deeply committed to the promotion of standards around the globe specifically because of this important role in ensuring the quality of testing, the reproducibility of test results, and ultimately the quality of care.

You can read more about the Lead Detect prize here, including interviews with the three finalists: Meridian Bioscience (1st place, an electrochemical sensor), OndaVia (2nd place, optical technology), and GlucoSentient (3rd place, a blood glucose meter), where they talk about their motivations, strategy, solutions, and the role of standards in supporting their development.