The LymeX Diagnostics Prize has announced that both Labcorp and Quest Diagnostics will serve as industry supporters of the LymeX competition.

Labcorp and Quest Diagnostics will provide non-financial in-kind support, helping Phase 3 teams deepen their understanding of the diagnostics industry, how clinical laboratories operate, and how to work with commercial laboratories.

Phase 3 teams will also 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.

Through August, the cohort has access to technical assistance on topics such as regulatory planning, clinical study design and implementation, clinician and patient considerations, manufacturing processes and quality management systems, and commercial development. To support evaluation and encourage innovative approaches, the LymeX Diagnostics Prize has published a target product profile for a diagnostic test.

Teams, subject matter experts to convene at virtual Industry Day

The one-day virtual August event will provide a unique opportunity for teams to learn from industry clinical laboratory subject matter experts through presentations and panel discussions. Labcorp and Quest Diagnostics sessions will focus on industry interests in new Lyme disease diagnostics, as well as practical, technical, and other relevant considerations for offering access to novel diagnostics through clinical laboratories.

Phase 3 to award up to $2.1 million in prizes

In October, each team will submit a concept paper that details the FDA engagement undertaken and implementation of feedback received, new or improved analytical performance data, final clinical performance study protocol, and progress achieved in planning and initiating its clinical performance study.

The Phase 3 teams will then present and publicize their diagnostic tests at Demo Day, showcasing their proposed solutions to stakeholders from government and industry, including clinician and consumer organizations.

The competition judging panel — composed of experts across sectors such as biology, clinical and technology translation, patient experience and advocacy, diagnostic science and technology, innovation, and ethics — will evaluate eligible submissions according to official Phase 3 evaluation criteria. The judging panel does not include representatives from either Labcorp or Quest Diagnostics. Based on this evaluation and judges’ recommendations, Phase 3 will award up to six prizes of $350,000 each.

The LymeX Diagnostics Prize is made possible thanks to a more than $10 million pledge from the Steven & Alexandra Cohen Foundation. Neither Labcorp nor Quest Diagnostics are providing any remuneration to the awards.

SOURCE: LymeX Diagnostic Prize