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Detect to Protect Challenge: A Live Animal Test for CWD

The challenge invites innovators to submit their idea for a diagnostic test for the early detection of CWD in a live animal, prior to signs.
stage:
Submission Deadline
prize:
$170,000
Partners
Overview

Challenge Overview

A Live Animal Test for CWD

Sensis, on behalf of The United States Department of Agriculture (USDA) Agricultural Research Service (ARS), is hosting the Detect to Protect Challenge: A Live Animal Test for Chronic Wasting Disease (CWD). The challenge invites innovators to submit their idea for a diagnostic test for the early detection of Chronic Wasting Disease (CWD) in a live animal, prior to clinical signs.

 

Our goal is to inspire the innovative development of a novel diagnostic test that will successfully detect CWD in samples provided by USDA for this challenge. Competitive solutions to this challenge shall consist of novel diagnostic tests that are sensitive and specific for CWD, producing timely and repeatable results on samples easily obtained from live deer. Competitive solutions will also be cost-effective and readily manufacturable. The ideal solutions to this challenge are diagnostic tests that would be eligible for approval as an official Chronic Wasting Disease test by the Administrator of the Animal and Plant Health Inspection Service (APHIS), USDA.

 

Sensis will award prizes valued up to $170,000. The Detect to Protect Challenge: A Live Animal Test is calling upon innovators and scientists,  researchers, and/or startup companies to submit their proposal for developing a novel diagnostic test for the early detection of CWD in a live animal, prior to clinical signs. 

 

Background

Chronic wasting disease (CWD) is a progressive, fatal, neurodegenerative disease of cervids (deer, elk, reindeer, and moose). The infectious agent is a misfolded form of the endogenous prion protein. The normally folded form of the protein is found throughout the body, with the highest concentration in the brain, spinal cord, and lymphoid tissues. With infection, the misfolded form accumulates in the highest concentration in the brain, spinal cord and lymphoid tissues along the alimentary tract. Clinical signs of CWD infection can take years to develop, prior to which animals without clinical signs can still spread disease. Chronic wasting disease belongs to a family of diseases called prion diseases or transmissible spongiform encephalopathies (TSEs). Other TSEs include bovine spongiform encephalopathy (BSE) in cattle, scrapie in sheep and goats, and Creutzfeldt-Jakob disease in humans.

Chronic wasting disease continues to spread in farmed and wild cervids and is of particular concern because the disease can spread at the interface between farmed and wild cervids. CWD is spread through direct animal-to-animal contact via infected body fluids and/or excreta, or indirectly through contact with CWD-contaminated items in the environment, such as soil and other fomites; however, all modes of transmission have yet to be determined.

 

Current Solutions & Limitations

Today, there are two official postmortem diagnostic tests for CWD surveillance in cervids: Immunohistochemistry and the ELISA test. Immunohistochemistry (considered the gold standard) and the ELISA test both utilize brain and lymph node tissue. The ELISA test is commonly employed by wildlife agencies.

While these two tests are routinely used, they have limited ability to test live animals and cannot be used for samples such as feces, blood, and saliva. CWD has a long incubation period between exposure and clinical signs. Development of an accurate live animal diagnostic assay could allow the detection of disease earlier, limiting direct and indirect transmission.

Challenge Goal 

Our goal is to inspire the innovative development of a novel diagnostic test that will successfully detect CWD in samples provided by USDA for this challenge. Competitive solutions to this challenge shall consist of novel diagnostic tests that are sensitive and specific for CWD, producing timely and repeatable results on samples easily obtained from live deer. Competitive solutions will also be cost-effective and readily manufacturable. The ideal solutions to this challenge are diagnostic tests that would be eligible for approval as an official Chronic Wasting Disease test by the Administrator of the Animal and Plant Health Inspection Service (APHIS), USDA.

 

Guidelines

Challenge Guidelines

Phase 1: Design Paper

The Design Paper phase invites all eligible contestants to submit a concept paper outlining their team’s proposed solution, approach, capabilities, knowledge and skills for this challenge.

Participants’ Design Papers will be reviewed by a panel of subject matter experts who will select up to seven participants for awards. Awardees will receive a) an invitation to Phase 2;

b ) up to $10,000 to assist in developing their rapid tests for Phase 2; and c) USDA-ARS technical resources to enable the development of the test and application for a product license from the Center for Veterinary Biologics, USDA-APHIS.

 

How to Enter

Review the Official Rules and resources provided on the challenge website. By the May 7 deadline, submit a design paper through the challenge website.

  • Register for the challenge by completing the registration form.
  • Review the USDA-ARS provided resources in the ‘Resources’ tab on the challenge website.
  • Complete the submission requirements for the Design Paper phase.
  • Submit the required Design Paper as your entry on the challenge website.

 

Phase 1: Submission Requirements

Cover Page and Abstract (1 page)

  • Participant’s Name (Team, Organization or Company Name) and list of individual team member(s).
  • Participant’s Location (City, State/Region and Country).
  • Team Logo.
  • Official Representative and their preferred contact information (including email, phone, and physical mailing address).
  • Abstract (500-word MAXIMUM): The unique aspects of the participant’s approach and the potential impact that the proposed approach could have in achieving the goals of the challenge.

Project Description (8 pages max; if included, a list of citations is not included in this page limit)

  • Describe the development plan including the test format, components, parameters, and development timeline.
  • Provide cost estimates for testing (e.g., per animal) and test manufacture (all components and reagents).
  • The project description should specifically address the scoring criteria.

Optional Visual Aid (1-2 pages, 2-3 minutes long)

  • An optional visual aid to supplement the submission, such as a short video or another visualization.

  

Phase 1: Judging Criteria

Design Paper

Design Paper submissions will be evaluated based on the following criteria:

INNOVATION 30%

  • The proposed Solution presents a novel idea, or a novel combination of ideas, or a distinct advancement of the current state of detection technology for CWD.
  • The proposed Solution represents the creation and development of a new live animal test that will fundamentally improve our ability to detect deer with CWD.
  • The proposed Solution can be implemented in any veterinary diagnostic laboratory.

COST EFFECTIVENESS 20%

  • The proposed Solution includes an estimate of cost per animal for the required reagents and supplies.
  • If the Solution is scalable, the minimum and maximum number of samples per run of the assay is provided and the cost per animal of required reagents and supplies is estimated over that range.

FEASIBILITY 50%

  • The proposed Solution is based on sound scientific and theoretical principles.
  • The proposed Solution demonstrates how the proposed diagnostic or laboratory test will function in its proposed setting.
  • The proposed Solution identifies potential obstacles to implementing the test and how those obstacles will be overcome.
  • The proposed Solution identifies the resources needed to implement the test on live cervids.

 

Phase 1 Awards
Open to all

Up to 7 Teams Selected to Advance to Phase 2. - $10,000

Awarded to each team to develop their rapid test in Phase 2.

 

Phase 2: Submission Requirements

Teams selected to compete in Phase 2 of the challenge will be required to complete the following milestones prior to evaluation:

Milestone 1: Obtain USDA-APHIS Permit Approval

The lab to which the samples will be provided has an USDA-APHIS transport permit that allows for the receiving and handling of prion-infected materials. USDA-ARS and USDA-APHIS will provide information as needed for obtaining a lab permit if a team does not already have a permit. The instructions on how to obtain a lab permit can be found here.

Milestone 2: Successfully Complete Proof-of-Concept with CWD Positive Samples (Proof-of-Concept) 

The prototype correctly discriminated between samples obtained from healthy deer and deer with late-stage CWD infection.

Final Evaluation: Submit Coded Samples Test Results

Challenge participants will submit their coded samples test results for final evaluation. 

 

Phase 2: Judging Criteria
Experimentation and Early Development

Phase 2 final evaluation will be based on the following criteria:

PRELIMINARY SENSITIVITY AND SPECIFCITYreliminary Sensitivity and Specificity (40%)

  • Differentiation of samples from healthy deer and deer in the early stages of CWD infection.

TRANSFERABILITY(35%)

  • The participant provides a plan for how they intend to have their assay developed and made available to USDA-APHIS National Veterinary Services Laboratories (NVSL) and National Animal Health Laboratory Network (NAHLN).

REPRODUCIBILITY (25%)

  • Identical results obtained with replicate samples.

 

Phase 2 Awards

Open to Phase 1 Winners

1st Place - $60,000

2nd Place - $30,000

Optional Prize - $10,000

  

Timeline Overview

  • February 22, 2021 - Open Submissions for Phase 1 – Design Paper
  • May 7, 2021 - Phase 1 – Submissions Due
  • July 21, 2021 - Phase 2 Begins – Experimentation and Early Development of Laboratory or Diagnostic Tests
  • TBA - Individual USDA Expert Virtual Session
  • August 26, 2021 - Confirm or Obtain Permit
  • September 15, 2021 - Receive Phase 1 test samples
  • October 27, 2021 - Complete Proof-of-Concept demonstration using positive and negative test samples.
  • November 16, 2021 - Receive coded samples
  • January 11, 2022 - Phase 2 – Coded samples test results submission due
Timeline
Forum
Teams 4
FAQ
Rules

Rules

General Submission Rules & Requirements for All Phases

Rules and Requirements for Detect to Protect: A Live Animal Test for CWD

In order to be eligible for review, recognition and award, the submission and participant(s) must meet the following requirements:

  • Deadline – The submission must be available for evaluation by May 7, 2021 by 11:59pm ET.
  • No USDA logo – The submission must not use USDA’s logo or official seal and must not claim USDA endorsement.
  • The submission must be original, the work of the participant(s), and must not infringe, misappropriate or otherwise violate any intellectual property rights, privacy rights, or any other rights of any person or entity.
  • It is an express condition of submission and eligibility that each participant warrants and represents that the submission is solely owned by the participant(s), that the submission is wholly original with the participant(s), and that no other party has any ownership rights or ownership interest in the submission. The participant(s), must disclose if they are subject to any obligation to assign intellectual property rights to parties other than the contest participant(s), if the participant(s) is licensing or, through any other legal instrument, utilizing intellectual property of another party.
  • Each participant further represents and warrants to USDA that the submission, and any use thereof by USDA shall not: (i) be defamatory or libelous in any manner toward any person, (ii) constitute or result in any misappropriation or other violation of any person’s publicity rights or right of privacy, or (iii) infringe, misappropriate or otherwise violate any intellectual property rights, privacy rights or any other rights of any person or entity.
  • Each submission must be in English.
  • Submissions will not be accepted, evaluated, or considered for award if they contain any matter that, in the sole discretion of USDA is indecent, obscene, defamatory, libelous, in bad taste, demonstrates a lack of respect for public morals or conduct, promotes discrimination in any form, or which adversely affects the reputation of USDA. USDA shall have the right to remove any content from the Website in its sole discretion at any time and for any reason, including, but not limited to, any online comment or posting related to the Challenge.
  • If Sensis, in its discretion, finds any submission to be unacceptable, then such submission shall be deemed disqualified.

Judging Panel

The submissions will be judged by a panel of subject-matter expert(s) selected by USDA. The panel consists of USDA and non-USDA experts who will judge the submissions according to the judging criteria identified above in order to select winners. Judges will not (A) have personal or financial interests in, or be an employee, officer, director, or agent of any entity that is a registered participant in a contest; or (B) have a familial or financial relationship with an individual who is a registered participant.

The decisions of the Judging panel for the contest will be announced in accordance with the dates noted in the “Important Dates” section of these rules. USDA will not make all participants’ evaluation results from the Judging panel available to participants or the public.

Verification of Winners

ALL CONTEST WINNERS WILL BE SUBJECT TO VERIFICATION OF IDENTITY, QUALIFICATIONS AND ROLE IN THE CREATION OF THE SUBMISSION BY USDA.

In the sole discretion of USDA, a potential winner will be deemed ineligible to win if: (i) the person/entity cannot be contacted; (ii) the person/entity fails to provide Participant Eligibility Verification within the required time period; (iii) the prize or prize notification is returned as undeliverable; or (iv) the submission or person/entity is disqualified for any other reason. In the event of a disqualified winner, Sensis, in their sole discretion, may award the applicable prize to an alternate winner, when applicable.

Eligibility

  1. The Prize is open to anyone age 18 or older participating as an individual or as a team. Individual competitors and teams may originate from any country, as long as United States federal sanctions do not prohibit participation (see: https://www.treasury.gov/resource-center/sanctions/Programs/Pages/Programs.aspx).
  2. Participants may not be a Federal entity or Federal employee acting within the scope of their employment. Any other individuals or legal entities involved with the design, production, execution, distribution or evaluation of the Challenge are not eligible to enter. Former USDA Federal employees are not eligible to compete in a prize challenge within one year from their exit date. Individuals currently receiving USDA funding through a grant or cooperative agreement are eligible to compete, but may not utilize the previous USDA funding for competing in this challenge. Non-USDA Federal employees acting in their personal capacities should consult with their respective agency ethics officials to determine whether their participation in this competition is permissible.
  3. Submissions must originate from either the U.S. or a designated country (see definition of designated country at https://www.acquisition.gov/far/part-25#FAR_25_003), OR have been substantially transformed in the US or designated country prior to prototype delivery pursuant to FAR 25.403(c).
  4. Submissions must be made in English. All challenge-related communication will be in English.
  5. You are required to ensure that all releases or transfers of technical data to non-US persons comply with International Traffic in Arms Regulation (ITAR), 22 C.F.R. §§ 120.1 to 130.17.
  6. To be eligible to compete, you must comply with all the terms of the challenge as defined in the Challenge-Specific Agreement.
  7. By participating in the challenge, each competitor agrees to submit only their original idea. Any indication of “copying” amongst competitors is grounds for disqualification.
  8. All applications will go through a process of due diligence; any application found to be misrepresentative, plagiarized, or sharing an idea that is not their own will be automatically disqualified.
  9. All ineligible applicants will be automatically removed from the competition with no recourse or reimbursement.
  10. No purchase or payment of any kind is necessary to enter or win the competition.
  11. Void wherever restricted or prohibited by law.

Additional Requirements

  1. An individual or entity shall not be deemed ineligible because the individual or entity used Federal facilities or consulted with Federal employees during a competition if the facilities and employees are made available to all individuals and entities participating in the competition on an equitable basis.
  2. Participants must also agree to assume any and all risks and waive claims against the Federal Government and its related entities, except in the case of willful misconduct, for any injury, death, damage, or loss of property, revenue, or profits, whether direct, indirect, or consequential, arising from my participation in this prize contest, whether the injury, death, damage, or loss arises through negligence or otherwise.
  3. Participants must agree to indemnify the Federal Government against third party claims for damages arising from or related to USDA-ARS Live Animal Test for CWD Challenge activities.
  4. Sensis reserves the right to cancel, suspend, and/or modify the USDA-ARS Live Animal Test for CWD Challenge, or any part of it, for any reason, at Sensis’ sole discretion.

Teams

A challenge submission can be from an individual or a team. Whether as an individual or team member, each person can only participate on one submission. If a team of individuals, a corporation, or an organization is selected as a prize winner, Sensis will award a single dollar amount to the Official Representative. The Official Representative is solely responsible for allocating any prize amount among its member participants as they deem appropriate. Sensis will not arbitrate, intervene, advise on, or resolve any matters between entrant members. It will be up to the winning team(s) to reallocate the prize money among its member participants, if they deem it appropriate.

Intellectual Property (IP) Rights

  1. Participants are free to discuss their entry and the ideas or technologies that it contains with other parties, are encouraged to share ideas/technologies publicly, are encouraged to collaborate or combine with other participants to strengthen their solutions and are free to contract with any third parties. Participants should be aware that any agreement signed or obligation undertaken in regard to their participation in the USDA-ARS Live-animal Test for CWD Challenge that conflicts with the challenge rules, terms, and conditions may result in disqualification of the participant’s entry.
  2. By participating in this challenge, each participant (whether individuals, participating singly or in a group, or entities) warrants that he or she is the sole author or owner of, or has the right to use, any copyrightable works that the submission comprises, that the works are wholly original with the participant (or is an improved version of an existing work that the participant has sufficient rights to use and improve), and that the submission does not infringe any copyright or any other rights of any third party of which participant is aware. In addition, each participant (whether individuals, participating singly or in a group, or entities) grants to USDA an irrevocable, paid-up, royalty-free nonexclusive worldwide license to reproduce, publish, post, link to, share, and display publicly (e.g., on websites) the submission and abstracts on the web or elsewhere. Each participant will retain all other intellectual property rights in their submissions, as applicable. To participate in the challenge, each participant must warrant that there are no legal obstacles to providing the above-referenced nonexclusive licenses of participant rights to the Federal government. To receive an award, winners will retain ownership of their intellectual property rights in the solution, but participants must grant to the Federal government the nonexclusive, nontransferable, irrevocable, paid up license to practice, or have practiced for or on its behalf, the solution throughout the world for Federal government purposes. Each participant also warrants that the work is free of security threats and/or malware.
  3. Each participant must clearly delineate any Intellectual Property (IP) and/or confidential commercial information contained in an entry that the participant wishes to protect as proprietary data.
  4. All materials submitted to USDA as part of an entry become USDA agency records. Any confidential commercial or financial information contained in an entry must be clearly designated at the time of entry.
  5. If the entry includes any third-party works (such as third-party content or open source code), the participant must be able to provide, upon request, documentation of all appropriate licenses and releases for use of such third-party works. If the participant cannot provide documentation of all required licenses and releases, USDA and Partners reserve the right, at their sole discretion, to disqualify the entry.

Warranties:

By submitting an entry, each participant represents and warrants that the participant is the sole author and copyright owner of the submission; that the submission is an original work of the participant and that the participant has acquired sufficient rights to use and to authorize others, including the USDA, to use the submission, as specified throughout the Official Rules, that the submission does not infringe upon any copyright or upon any other third party rights of which the participant is aware; and that the submission is free of malware.

By submitting an entry, the participant represents and warrants that all information submitted is true and complete to the best of the participant’s knowledge, that the participant has the right and authority to submit the entry on the participant’s own behalf or on behalf of the persons and entities that the participant specifies within the entry, and that the entry (both the information and materials submitted in the entry and the underlying technology/method/idea/treatment protocol/solution described in the entry):

  • is the participant’s own original work, or is submitted by permission with full and proper credit given within the entry;
  • does not contain trade secrets (the participant’s or anyone else’s);
  • does not knowingly violate or infringe upon the patent rights, industrial design rights, copyrights, trademarks, rights of privacy, publicity or other intellectual property or other rights of any person or entity;
  • does not contain malicious code, such as viruses, malware, timebombs, cancelbots, worms, Trojan horses or other potentially harmful programs or other material or information;
  • does not and will not violate any applicable law, statute, ordinance, rule or regulation, including, without limitation, United States export laws and regulations, including but not limited to, the International Traffic in Arms Regulations and the Department of Commerce Export Regulations; and
  • does not trigger any reporting or royalty or other obligation to any third party.

By making a submission to this prize competition, each participant agrees that no part of its submission includes any Trade Secret information, ideas or products. All submissions to this prize competition are deemed non-proprietary. Since USDA does not wish to receive or hold any submitted materials “in confidence” it is agreed that, with respect to the participant’s entry, no confidential or fiduciary relationship or obligation of secrecy is established between USDA and the participant, the participant’s team, or the company or institution the participant represents when submitting an entry, or any other person or entity associated with any part of the participant’s entry.

Additional Terms and Conditions

This document outlines the Official Rules for the USDA-ARS Detect to Protect Challenge: A Live-animal Test for CWD. Nothing within this document or in any documents supporting the Detect to Protect Challenge shall be construed as obligating the USDA or any other Federal agency or instrumentality to any expenditure of appropriated funds, or any obligation or expenditure of funds in excess of or in advance of available appropriations.

Challenge Subject to Applicable Law

The challenge is subject to all applicable federal laws and regulations. Participation constitutes each participant’s full and unconditional agreement to these Official Rules and administrative decisions, which are final and binding in all matters related to the contest. Eligibility for a prize award is contingent upon fulfilling all requirements set forth herein. This notice is not an obligation of funds; the final award of prizes is contingent upon the availability of appropriations.

Participation is subject to all U.S. federal, state and local laws and regulations. Participants are responsible for checking applicable laws and regulations in their jurisdiction(s) before participating in the prize competition to ensure that their participation is legal. The USDA shall not, by virtue of conducting this prize competition, be responsible for compliance by participants in the prize competition with Federal Law including licensing, export control, and nonproliferation laws, and related regulations. Individuals entering on behalf of or representing a company, institution or other legal entity are responsible for confirming that their entry does not violate any policies of that company, institution or legal entity.

Resolution of Disputes

Sensis is solely responsible for administrative decisions, which are final and binding in all matters related to the contest.

In the event of a dispute as to any registration, the authorized account holder of the email address used to register will be deemed to be the participant. The “authorized account holder” is the natural person or legal entity assigned an email address by an Internet access provider, online service provider or other organization responsible for assigning email addresses for the domain associated with the submitted address. Participants and potential winners may be required to show proof of being the authorized account holder.

Publicity

The winners of these prizes (collectively, “Winners”) will be featured on the USDA website, newsletters, social media, and other outreach materials.

Except where prohibited, participation in the contest constitutes each winner’s consent to the USDAs’ and its agents’ use of each winner’s name, likeness, photograph, voice, opinions, and/or hometown and state information for promotional purposes through any form of media, worldwide, without further permission, payment or consideration.

Liability and Insurance

Any and all information provided by or obtained from the Federal Government is without any warranty or representation whatsoever, including but not limited to its suitability for any particular purpose. Upon registration, all participants agree to assume and, thereby, have assumed any and all risks of injury or loss in connection with or in any way arising from participation in this contest, development of any application or the use of any application by the participants or any third-party. Upon registration, except in the case of willful misconduct, all participants agree to and, thereby, do waive and release any and all claims or causes of action against the Federal Government and its officers, employees and agents for any and all injury and damage of any nature whatsoever (whether existing or thereafter arising, whether direct, indirect, or consequential and whether foreseeable or not), arising from their participation in the contest, whether the claim or cause of action arises under contract or tort. Upon registration, all participants agree to and, thereby, shall indemnify and hold harmless the Federal Government and its officers, employees and agents for any and all injury and damage of any nature whatsoever (whether existing or thereafter arising, whether direct, indirect, or consequential and whether foreseeable or not), including but not limited to any damage that may result from a virus, malware, etc., to Government computer systems or data, or to the systems or data of end-users of the software and/or application(s) which results, in whole or in part, from the fault, negligence, or wrongful act or omission of the participants or participants’ officers, employees or agents.

Records Retention and FOIA

All materials submitted to Sensis as part of a submission become official records and cannot be returned. Any confidential commercial information contained in a submission should be designated at the time of submission. Submitters will be notified of any Freedom of Information Act requests for their submissions in accordance with 29 C.F.R. § 70.26.

508 Compliance

Participants should keep in mind that the Sensis considers universal accessibility to information a priority for all individuals, including individuals with disabilities. In this regard, the Sensis is strongly committed to meeting its compliance obligations under Section 508 of the Rehabilitation Act of 1973, as amended, to ensure the accessibility of its programs and activities to individuals with disabilities. This obligation includes acquiring accessible electronic and information technology. When evaluating submissions for this contest, the extent to which a submission complies with the requirements for accessible technology required by Section 508 will be considered.

General Conditions

Sensis reserves the right to cancel, suspend, and/or modify the challenge, or any part of it, if any fraud, technical failures, or any other factor beyond Sensis’ reasonable control impairs the integrity or proper functioning of the contest, as determined by Sensis in its sole discretion.