Today we are releasing our target product profile (TPP) report for blood level lead testing, in partnership with Renaissance Philanthropy and Pahlé India Foundation. To our knowledge, this is the first ever such profile targeting an environmental contaminant, which we have devised to promulgate the urgent need for better measurement tools for this pollutant, particularly in low-resource settings where children are disproportionately affected. The TPP is a platform for funders+practitioners to collaboratively scale lead monitoring to meet the magnitude of the challenge and to broadly mobilize the biotech community to tackle the challenges of pollution.
In this essay, we share why we chose Lead, why we believe we can rapidly scale new technologies and share a few technical highlights of the target product profile for blood lead level.
To join us in this critical work or learn more about upcoming funding opportunities, reach out to Pollution@homeworld.bio.
Leading into Lead
The health effects of pollution are too big to see. We observe with shock, but little agency, what these abiotic stresses do to our fertility, our obesity, our children’s neural development and the collapse of ecosystems. In our opinion, scientific efforts around pollution have biased towards policy work and under-resourced the technological work to detect and remediate. Policy is important and has had some success, but the status quo continues to get worse. So if we really are serious about creating change, of protecting the biosphere and ushering in a future in which life and industry can co-exist, then it’s time to go straight to building solutions. We must empower the community of technologists and front-line practitioners to show what is possible in pollution management.
“When I worked on the brain, I worked on things that were too small to see.
Now that I work for the planet, I work on things that are too big to see.”
Paul Reginato
Lead (Pb2+) alone impacts 800 million children worldwide (yes, that’s one in three children), robbing generations of fully developed brains and leaving them with chronic health issues. Because of this immense challenge and well-understood disease causality, lead is a high impact problem area within the broad theme of pollution. Lead poisoning has the dual challenges of detection and treatment, and we believe the higher leverage starting point is detection1. The gold standard method for lead detection, inductively coupled plasma mass spectrometry (ICP-MS), is a highly accurate lab-based test but requires expensive instrumentation and an invasive venous blood draw that must be taken by a trained phlebotomist. The status quo approaches won’t scale without new technology breakthroughs.
There is just one portable lead detection device on the market, called LeadCare II, but it uses a 20-year old technology that is less sensitive and less trustworthy than what we need. The device is too expensive to scale and incompatible with many resource-constrained settings. Researchers at the Center for Global Development published a seminal white paper, with a roundtable of lead experts, which described the current state of blood lead level testing and showcased the need for new types of methods. But, creating a new device requires a long FDA regulatory journey and innovators are constrained by funds that bias against low-cost tests. Government buyers currently pay around $18 per lead test whereas leading diagnostic startups are drawn toward diseases that warrant payments orders of magnitude higher. So despite the flaws of the LeadCare II device, it still has a monopoly on the market.
Target Product Profiles are a proven method of catalyzing innovators to solve high-impact problems. TPPs have a rich history as a form of roadmapping that synchronizes the needs of clinicians with the capacity of innovators and the impact targets of funders. Perhaps the best example is the pneumococcal vaccine that ultimately rallied the $1.5B needed to vaccinate 300M kids around the world. We at Homeworld Collective, Renaissance Philanthropy and Pahlé India set out to create a Target Product Profile (TPP) for a Blood Lead Level Test.
Behind the TPP is the rich collaboration of over 50 biotechnologists, clinicians, public health implementers, and funders, funneled into 1:1 conversations and virtual convening of experts from across the globe so that we could receive their in-depth feedback. This is the first step in building a call for funding, with upcoming opportunities for innovators to build to these product requirements outlined in the TPP.
Inspiration from COVID Testing and Carbon Dioxide Removal
In the past four years, we have seen two powerful spikes of innovation around COVID Testing and Carbon Dioxide Removal. We can bring these lessons to rally biotech into the challenges inside the lead problem.
In 2018, the funding for carbon capture was virtually non-existent, but in 2022, it shot to over a billion dollars. This funding was spearheaded by the flagship Frontier Advanced Market Commitment to be the first customer to companies building carbon capture products. The catalyst for this was a NASEM report and internal leadership from leading philanthropies that changed funders’ minds that CDR was both imminent and addressable.
Similarly, within a year of the COVID-19 pandemic the US went from zero testing capacity to millions tested, with some tests dropping from around $200 to as low as ~$10 per test, depending on the type and location. This was partly overseen by a presidential task force, partly by the NIH’s Rapid Acceleration of Diagnostics (RADx®) initiative and also by a vibrant community of volunteer practitioners (including Homeworld’s co-founder Dan Goodwin and Garden Grantees Pranam Chatterjee and Jenny Molloy) who responded in force to the acute threat of the pandemic.
But market forces and government funding do not yet exist at sufficient levels to drive a similar 20x cost reduction and massive scale-up. This is partly because of substantial technology challenges, and partly because potential innovators have to navigate both technical and deployment challenges. Bringing the policy and funding expertise from Renaissance and Pahlé, and combining it with the technical roadmap expertise of Homeworld, we created a structured approach that aligns funders, innovators, and clinicians.
Target Product Profile as a Tool in the Field-Builders Toolbox
For those outside of medical technology development, the TPP might be a foreign concept. Here are three big wins of TPPs:
- Pneumococcal vaccines lead to two advanced market commitments that were each over $1B, that spurred the production of the vaccine to immunize 150M children
- Within months after the COVID-19 pandemic began, the World Health Organization released a TPP for a COVID Vaccine, which helped mobilize over $6.4 billion dollars across donor governments, multilateral organizations, private foundations, and countries (Rouw et al., 2021, Budish 2022).
- 15 TPPs on neonatal care devices for low and middle-income countries were devised and published simultaneously in UNICEF’s database, to drive the supply of new products by showcasing the consensus of unmet needs among over 100 experts, implementers, and users
(For those who want to learn more, check out Becca Kirby’s TPP Playbook!)
Highlights of the TPP for Blood Lead Level Testing
There are several major hurdles when devising new tools to measure pollutants as compared to other biological analytes. Firstly, the nature of environmental exposures is more complex than today’s mass-market diagnostics. A virus, like COVID, is detected in a solution through amplifying nucleic acids resulting in a singular, binary response which is generally actionable. However, when detecting chemicals, multiple axes of exposure (magnitude, duration, temporality) must be considered, and the necessary actions taken will be dependent on the reported concentration, population and setting.
This TPP contains 47 product requirements to achieve new innovation in lead testing at scale. Some critical and foundational requirements include:
- Affordability: Ideal is $1/test. Currently, the portable device costs $3000 in the U.S. and each test is billed at an average of $18 per lead test (some state-specific costs are here). Most countries cannot afford to procure the portable device at this cost. Cheaper tests may soon be achievable given advancements in new technologies like biosensors, lateral flow assays, and immunoassays.
- Accessibility: Ideal is a durable device that fits in two hands. The current portable lead detection device sits on a countertop in a clinic and requires ample training. Future testing should be readily available at the “point-of-use” with minimal training and in rugged settings, including high-elevations and high-humidity.
- Modularity: Ideal is easily swappable device components. A singular test for a singular pollutant may struggle to overcome the market failures and high barriers to entry that we described. Innovators in the diagnostic space have shown promise in building devices that have the added compatibility with multiple sample types (e.g., water and blood) or several pollutants beyond lead (e.g., other heavy metals like chromium, arsenic, etc.). Some organizations that use biosensors already have this added degree of versatility integrated into their candidate products.
Conclusion: A Collaborative Path Forward
With this TPP, we’ve created a clear roadmap for developing affordable, accessible lead testing technology that can work at scale in resource-constrained settings. But a roadmap is just the beginning – we need coordinated action from funders, innovators, and practitioners to turn these specifications into reality.
The recent launch of the $150M Partnership for Lead Free Future and growing momentum in the field signals a unique moment of opportunity. Through strategic investment, technological innovation, and commitment to collaboration, we can dramatically reduce the global burden of lead exposure. For innovators working on detection technologies, for funders looking to catalyze change, and for practitioners on the front lines – the time to act is now. Together, we can protect future generations from the devastating effects of lead exposure and build a cleaner, healthier world for all.
Acknowledgements
Our work on developing this roadmap for blood lead level testing was made possible by the wonderful partnerships with the Nathan Cummings Foundation, Grantham Foundation for the Protection of the Environment, and the Chan Zuckerberg Initiative. We thank them for their strategic input and support for Homeworld Collective’s mission to grow the field of climate biotech.
- Treatment depends on the blood-lead level, and the current standard of care is a mixture of removing sources of lead and chelation therapy. So treatment depends on measurement, and the direct therapies are unlikely to change much without broader attention and outcome monitoring. ↩︎