CLSI partners with LymeX Diagnostics Prize to support Phase 4 team advancing Lyme disease diagnostics

/EIN News/ -- MALVERN, Pa., June 11, 2025 (GLOBE NEWSWIRE) -- Clinical & Laboratory Standards Institute (CLSI) is proud to announce its partnership with LymeX Diagnostics Prize to support teams entering Phase 4 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 the organizations’ joint work last fall in support of the Lead Detection Prize competition. 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, supporting 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 of 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 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.

Read more about CLSI's support for the Lead Detection Prize.

About CLSI

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.

Contact:
marketing@clsi.org
1.610.688.0100