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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:
Phase 2
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
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Teams 4
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