MALVERN, PA — The Clinical & Laboratory Standards Institute (CLSI) has announced its partnership with the LymeX Diagnostics Prize to support Phase 4 of the competition, a critical stage aimed at accelerating the development of advanced diagnostic tools for Lyme disease.
Seven teams entering Phase 4 will focus on executing clinical validation plans and completing regulatory submissions to the U.S. Food and Drug Administration (FDA). The initiative underlines an urgent need for improved detection methods to combat Lyme disease, which, if left untreated, can lead to severe health complications.
Through this partnership, CLSI will provide participating teams with technical guidance and laboratory standards necessary for ensuring accuracy and reliability in their diagnostic validation efforts. This collaboration aligns with CLSI’s mission to advance diagnostic excellence and deliver improved patient outcomes.
“Partnering with CLSI for prize competitions has been instrumental to helping innovator teams reach their goals,” said Ben Alsdurf, Senior Director at Luminary Labs, which is working alongside CLSI on this initiative. “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.”
The LymeX Diagnostics Prize offers a total of over $10 million in funding to support the development of more accurate and timely diagnostic methods for Lyme disease. Phase 4 of the competition, backed by a $10 million pledge from the Steven & Alexandra Cohen Foundation, will award up to $3 million in prize funding. The first three phases collectively distributed $5.1 million to teams driving innovation in diagnostic solutions.
This collaboration also reflects CLSI’s ongoing work with Luminary Labs on other public health challenges, including last fall’s Lead Detection Prize, which focused on diagnostic tools to address pediatric lead exposure. Both efforts highlight the importance of robust standards in advancing public health through innovation.
The launch of Phase 4 comes shortly after Lyme Disease Awareness Month, observed each May to spotlight the impact of the tick-borne illness caused by Borrelia burgdorferi. Early detection is critical to effective treatment, as delays can lead to severe complications. With Lyme disease cases more prevalent in warmer months, the need for reliable diagnostics to support rapid responses grows even more pressing.
By providing the resources and expertise needed to guide the competition’s participants, CLSI and LymeX aim to usher in a new era of advanced diagnostic tools, ultimately improving care and outcomes for those impacted by this pervasive disease.
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