LymeX Diagnostics Prize - Phase 1 Leave Challenge Are you sure you want to leave this challenge? If you are the team lead, your submission will be deleted. There is no undo. modal modal Submission period now closed. The LymeX Diagnostics Prize is a competition to accelerate the development of Lyme disease diagnostics. The $1 million Phase 1 calls on scientific, technical, and clinical experts to submit innovative detection methods that will advance Lyme disease diagnostics.Submission ProcessThe goal of the LymeX Diagnostics Prize is to develop diagnostics that can accurately detect active Lyme disease infections in people. The multiphase competition will accelerate innovative solutions toward submission for Food and Drug Administration review. The deadline for Phase 1 submissions is 4:59 p.m. Eastern on Monday, August 8, 2022. Please submit at least one hour before the deadline to ensure your completed submission is received.When registering your team on Luminary Lightbox™, enter the name and email of the designated team lead.This form is best viewed using Chrome, Firefox, or Microsoft Edge. To prevent the loss of any entered information, please save the form as a draft prior to attaching any files or editing your team contact information. When submitting, please do not reload the form or exit the browser until you see a message confirming that we have received your submission.Submission formatThe concept paper should be a maximum of 10 pages; however, additional content may be included in an appendix. The appendix is not guaranteed to receive review by the judging panel, but may provide helpful context or clarification. Documentation should be submitted as a PDF and formatted with 1-inch margins (2.5 cm), using an easily read font with minimum 12-point font size for prose, and 10-point font size for tables and charts.Concept papers should include:Concept summary. An overview of the proof of concept and development plan, including a description of the proposed diagnostic test(s) and how it advances innovation in Lyme disease diagnostics.Solution description. A summary of why the proposed test will accurately diagnose an active infection of Lyme disease. This should include scientific rationale and initial validation data, if available, indicating the expected level of performance, with a focus on sensitivity and specificity of the proposed diagnostic test(s).Description of use. A summary of how the proposed diagnostic test(s) will be used to impact and improve clinical outcomes and patient quality of life, as well as population-level data of Lyme disease prevalence.Past progress and current status. A summary of current development status and a description of past progress, including initial data and how clinician and patient input has informed the design and initial development progress, as well as any past funding and how it has been used to advance development to date. The summary should also include a description of any prior interactions with FDA regarding the proposed solution, including copies of any correspondence between the Participant and FDA.Development plan. A roadmap for prototyping, iteration, testing/validation, and evaluation in future phases of the Competition and beyond. This should include a forward-looking budget and timeline, description of relevant technical challenges in the field of Lyme disease diagnostics, and summary of how clinician and patient input will continue to inform the development process. Development plans should consider the longer-term goals of the LymeX Diagnostics Prize.Team description. A description of the team, including areas of expertise and any anticipated gaps or additional partnerships that will be required to develop this solution. This should include a summary of any experience or success developing analogous solutions.If you encounter any issues, please email [email protected] with a description of the problem, a screenshot (if available), and the date and time of the occurrence.Please see the official rules, terms, and conditions for additional details concerning submissions and eligibility. * denotes required field Team lead Name * Email address * Phone number * Affiliation * Additional team members Please list each member of your team, including full name, affiliation (if applicable), and nationality. Submission overview Submission title * Provide the title of your submission. (10 words maximum) Submission headline * Provide a brief “elevator pitch” description summarizing your solution for non-scientific audiences. (100 words maximum) Technical abstract * Summarize your solution and rationale for how it could advance Lyme disease diagnostics. (500 words maximum) Patient and clinician abstract * Describe your solution, and how it could impact and improve the lives of patients and clinicians, in a way that is accessible for non-scientific readers. (300 words maximum) Concept paper Concept paper * The concept paper should be a maximum of 10 pages; however, additional content may be included in an appendix. The appendix is not guaranteed to receive review by the judging panel, but may provide helpful context or clarification. Documentation should be submitted as a PDF and formatted with 1-inch margins (2.5 cm), using an easily read font with minimum 12-point font size for prose, and 10-point font size for tables and charts. Submission checklist Please review and check all boxes before submitting: * I have read and understand the official rules, terms and conditions, and fully agree to them. I am an individual and/or represent a team, or I represent a legal entity that meets all eligibility criteria as stated in the official rules, terms and conditions. I did not receive assistance from any party associated with the design or administration of the competition when preparing this submission. All team members listed have agreed to be included in this submission and meet the eligibility requirements stated in the official rules, terms and conditions. All fields must be completed before clicking "Save & Next" Submission period now closed.