As part of its Lyme Innovation Accelerator (LymeX) partnership with the Steven & Alexandra Cohen Foundation, the U.S. Department of Health and Human Services (HHS) announced today a planned prize competition for scientific, technical, and clinical innovation to transform the diagnostics ecosystem for Lyme disease on Challenge.gov. Expected to launch in Spring 2022, today’s pre-launch announcement focuses on advancing innovation to improve diagnostic tests for Lyme disease.
Through an interagency agreement with the NASA Center of Excellence for Collaborative Innovation, the LymeX partnership is kicking off a prize competition called the LymeX Diagnostics Prize. Following the KidneyX Innovation Accelerator model, the prize competition will be a multi-year, multi-phased competition to develop diagnostics that detect active infection by Lyme disease-causing bacteria in people to be submitted to the Food and Drug Administration for review. The pre-launch announcement is another step forward, as the LymeX team formalizes its Steering Committee and governance process for launching the following multiple prize phases:
- LymeX Diagnostics Prize Phase 1: Initial call for concepts expected to open Spring 2022.
- LymeX Diagnostics Prize Phases 2 and 3: Development, prototyping, and validation.
“My office is embracing transformative innovation to accelerate scientific breakthroughs through cross-cutting collaboration and partnerships," said Assistant Secretary of Health Admiral Rachel L. Levine, MD at the Congressional Virtual Lyme Series. "Climate change is worsening the problem by expanding the geographic and seasonal distribution of ticks, which increases the risk of humans contracting Lyme and other tick-borne diseases.”
Lyme disease is the most common vector-borne disease in the United States, and the number of cases continue to grow at an alarming rate. According to the CDC, approximately 476,000 Americans are diagnosed with and treated for Lyme each year. To help address this complex healthcare challenge, HHS is leading an interagency process to develop a ground-breaking national strategy to address vector-borne diseases, including Lyme disease. Per the Kay Hagan Tick Act of 2019, the National Strategy on Vector-Borne Diseases Report will be delivered to Congress in 2023.
In 2021, the LymeX team spotlighted the Lyme disease community, including those with lived experience such as Lyme patients, advocates, and healthcare providers. By listening and learning from Americans with this complex condition, the LymeX team can address inequities with HHS. In May 2021, the first-ever Health+ (“health plus”) Human-Centered Design Report for Lyme disease gathered personal anecdotes and perspectives from Lyme patients and transformed them through qualitative and quantitative research into patient “archetypes” and collective “journeys.” The report provides valuable insight into Lyme diagnosis, treatment, persistent symptoms, disability, and opportunity areas with actionable recommendations for the future. HHS and the LymeX team are working hard to ensure an effective, equitable, and accountable Government effort will meet the needs of Americans living with Lyme disease.
LymeX is now poised to build upon almost 700 hours of human-centered design workshops, interviews, and listening sessions. By actively incentivizing the accelerated development of next-generation diagnostics, the LymeX team hopes to use the power of the crowd along with the American ingenuity to leverage public-private partnerships that will result in Lyme disease tests that directly detect an infection.