The state of Lyme disease
The CDC estimates that about 476,000 individuals may be diagnosed and treated for Lyme disease each year in the U.S. Caused primarily by infection with Borrelia burgdorferi, Lyme disease is most treatable in the first few weeks of infection, but diagnosis during this early stage poses a challenge to clinicians. Through the first three phases of the LymeX Diagnostics Prize, the competing teams have worked to develop new solutions for diagnostics that help detect Lyme disease in its early stages of infection.
When developing diagnostics, the laboratory community and standards-setting bodies are critical collaborators; their standards and testing provide the framework for validating new solutions against established performance criteria. In order to effectively innovate the landscape of Lyme disease diagnostics, lab services, and standards experts are working with Phase 4 teams to ensure their solutions meet quality and accuracy requirements. Since future diagnostics will likely be used by these laboratories, building relationships now will help streamline processes and provide better testing experiences to patients.
The LymeX Diagnostics Prize is pleased to welcome the Clinical & Laboratory Standards Institute (CLSI) as an industry supporter and to continue working with Labcorp and Quest Diagnostics in Phase 4. These industry supporters provide non-financial in-kind support to help Phase 4 teams navigate the complex diagnostics landscape and advance their innovative Lyme disease diagnostic solutions.
Reflections from the industry supporters
CLSI is a leader in developing consensus standards for laboratory medicine. This partnership, which provides Phase 4 teams with access to technical guidance and standards support, is instrumental in helping the teams complete their submissions for FDA approval:
“World-class device developers around the globe understand that using CLSI standards is vital in the development of the most reliable and accurate laboratory devices and tests possible,” said Dr. Barb Jones, CLSI Chief Executive Officer. “We are excited to collaborate with the LymeX Diagnostic Prize by providing these trusted standards to the Phase 4 teams, empowering them to innovate with confidence.”
Labcorp brings extensive experience in laboratory operations and test development to support Phase 4 teams in understanding the commercial diagnostics landscape:
“Labcorp is proud to support the LymeX Diagnostics Prize and its mission to accelerate innovation in Lyme disease diagnostics,” said Marcia Eisenberg, Ph.D., chief scientific officer at Labcorp. “Labcorp brings deep scientific expertise and operational insight to help these Phase 4 teams navigate the complexities of diagnostic development, and by sharing our knowledge, we aim to empower them to deliver solutions that improve health and improve lives.”
Quest Diagnostics continues its commitment to advancing Lyme disease diagnostics by sharing insights from their comprehensive laboratory network and decades of experience in bringing innovative tests to patients:
“We are happy to help the participating teams deepen their understanding of the diagnostics industry and how clinical laboratories operate,” said Meghan W. Starolis, M.S., Ph.D., HCLD(ABB), Senior Science Director of Infectious Disease at Quest Diagnostics.
These relationships represent a significant commitment from the clinical laboratory community to support breakthrough diagnostic innovations. Phase 4 teams will benefit from comprehensive guidance on regulatory planning, clinical study design and implementation, manufacturing processes and quality management systems, and commercial development strategies essential for bringing novel diagnostics to market. Additionally, the teams will have the opportunity to visit both Labcorp and Quest Diagnostics facilities to learn more about the clinical laboratory environment and their workflows, materials, and instrumentation.
Entrants plan for FDA submission by 2027 in $3 million Phase 4
Phase 4 invites seven teams to execute their clinical validation plans and complete regulatory submissions to the FDA. Each team that submits a regulatory package to the FDA that is accepted for substantive review will be eligible for a $200,000 milestone prize. To qualify, a team must also show its diagnostic test meets the minimum requirements of the target product profile. These milestone prizes are available through March 28, 2027.
Phase 4 will award up to $3 million in prizes, including milestone prizes and evaluation prizes. By January 29, 2027, teams will submit final summary papers detailing their device descriptions, final diagnostic performance data and analysis, and commercialization plans, as well as FDA Acknowledgement Letters confirming the agency’s receipt of the regulatory packages. A judging panel will evaluate summary papers based on the official Phase 4 evaluation criteria. Based on this evaluation, the panel will recommend up to three winners who will share up to $1.6 million in prizes.
Follow the teams through Phase 4: To receive all competition updates, subscribe to the LymeX Diagnostics Prize newsletter.