Lyme disease fundamentals

Lyme Disease (CDC)

Learn more about Lyme disease, the most common tick-borne disease in the United States.

Diagnosis of Lyme Disease (Johns Hopkins Lyme Disease Research Center)

Overview of current diagnosis of Lyme disease and common causes of misdiagnosis.

Report of the Testing and Diagnostics Subcommittee to the Tick-Borne Disease Working Group (HHS)

Discussion of current Lyme disease diagnostic methods’ limitations and associated issues, challenges, and opportunities.

Federal Research Updates on Lyme Disease Diagnostics (HHS)

Presentation and discussion detailing federal Lyme disease diagnostics research initiatives.

Strategic Plan for Tick-Borne Disease Research (NIH)

Report on NIH priorities across the research spectrum to develop knowledge and tools needed to combat tick-borne diseases.

LymeX partnership

LymeX Innovation Accelerator

Overview of past progress and current efforts from the LymeX partnership to accelerate progress in the diagnosis, prevention, and treatment of Lyme disease.

InnovationX (HHS)

Coalitions and collaborations to tackle “wicked problems,” leverage resources from diverse stakeholders, accelerate innovation, and scale solutions for real-world impact.

Ticks Suck: Fighting Lyme and Tickborne Diseases (Steven & Alexandra Cohen Foundation)

Information on funding, grantees, and other resources from the Cohen Foundation, the largest private funder of Lyme and tick-borne disease research in the country.

Public comment on diagnostic innovation (LymeX)

Responses from the public to the 2021 LymeX Request for Information on Accelerating Innovation in Diagnostic Testing for Lyme Disease.

Patient-centered design

Health+ Lyme Disease Human-Centered Design (LymeX)

Insights, archetypes, and journey maps developed through research with Lyme disease patients, caregivers, medical professionals, and subject matter experts.

The Value of Engagement (PCORI)

Information and tools to help innovators engage patients and stakeholders in research and development.

Diagnostics and medical technology development

Biodesign: The Process of Innovating Medical Technologies (Stanford University)

Frameworks and video modules on health solution development that integrates medicine, engineering, and business.

MassVentures Commercialization Accelerator (MassVentures)

Brief, no-cost courses on commercialization topics, including intellectual property, business model, and go-to-market strategy.

Regulatory navigation and commercialization

In Vitro Diagnostics (FDA)

Overview of how the FDA regulates in vitro diagnostic (IVD) products, including definitions and submission requirements for different approval pathways.

De Novo Classification Requests (FDA)

FDA requirements for the De Novo request process, which provides a marketing pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device.

RADx Radical: Data tools (NIH)

Various informational templates and guidance documents related to evaluation and validation of diagnostic tests.

Note

Note: All links and resources are provided for informational purposes only, and use is not required to participate in the competition. These resources are not intended to comprehensively address the topics referenced, and inclusion on this page does not constitute an endorsement by LymeX of any products or services offered or views expressed.

Know of any other relevant Lyme disease diagnostics resources?