CLSI Partners with LymeX Diagnostics Prize to Support Phase 4 Teams Advancing Lyme Disease Diagnostics

Malvern, PA – 05/19/2025 – Clinical & Laboratory Standards Institute (CLSI) is proud to announce its partnership with the LymeX Diagnostics Prize, Tick Disease Innovation Accelerator, to support teams entering Phase Four of the competition. This phase marks a pivotal milestone where seven teams will execute their clinical validation plans and complete regulatory submissions to the FDA to accelerate the development of Lyme disease diagnostics.

This effort builds on CLSI’s ongoing collaboration with Luminary Labs, following on the partnership between the two organizations last fall in support of the Lead Detect Prize. That initiative supported the acceleration of the development of diagnostic tools for lead exposure in children, a critical public health threat in the US that can cause significant developmental delays in children. Together, CLSI and Luminary Labs continue to support groundbreaking solutions that address pressing public health challenges through innovation and robust laboratory standards.

Through this partnership, CLSI will provide technical guidance and standards support to ensure teams are equipped with the best knowledge and tools to help them meet rigorous goals and requirements of diagnostic validation. This initiative aligns with both organizations’ commitment to advancing accurate, timely, and reliable diagnostic results that support patient care and outcomes.

“Partnering with CLSI for prize competitions has been instrumental to helping innovator teams reach their goals. CLSI’s laboratory standards not only guide the teams in their work but serve as a benchmark for their excellence. Collaborations like this help accelerate innovation and assist teams in finding their solutions faster,” said Ben Alsdurf, Senior Director at Luminary Labs.

The LymeX Diagnostic Prize is a $10+ million competition to accelerate Lyme disease diagnostics. Phase Four builds upon previous round efforts to support the development of reliable testing solutions that can improve patient outcomes and public health responses for people with Lyme disease infections. The first three phases of the competition collectively awarded $5.1 million in prizes, and Phase 4 will award up to $3 million in prize funding. The LymeX Diagnostics Prize is made possible thanks to a more than $10 million pledge from the Steven & Alexandra Cohen Foundation.

This partnership comes as the nation closes out the annual observation of Lyme Disease Awareness Month, underscoring the vital need for high-quality diagnostic solutions and upholding a shared mission to improve testing and regulatory preparedness to deliver the best care for patients.

Lyme disease is a tick-borne infection caused by the bacteria Borrelia burgdorferi. These ticks are a lot more prevalent in the warmer months of the spring. Lyme Disease Awareness Month is celebrated in May to foster greater awareness about the disease and other tick-borne illnesses. Lyme disease is treatable with early detection, but can also lead to severe long-term complications if left untreated, making the need for advancements in treatment all the more vital.

Learn more about the LymeX Diagnostics Prize.

CLSI is the leading global non-profit laboratory medicine standards development organization, with over 24,000 professional members, 2000 active volunteers, and 250 standards products. CLSI standards are recognized by laboratories, accreditors, and government agencies worldwide as the best way to improve their testing outcomes, maintain accreditation, bring products to market faster, and navigate regulatory hurdles.

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