Influenza A(H5) Call to Industry 75D301-24-CTI-00001.pdf

75D301-24-CTI-00001

CDC Open Call to Industry – Influenza A(H5) Diagnostic Test Development and Validation

Issued 06/10/2024

Part 1 - Introduction

The Centers for Disease Control and Prevention (CDC) is initiating an open call for innovative solutions to meet the CDC's diagnostic test development needs.

This open Call to Industry is considered to have high potential for one or more agreements that may be accomplished via CDC's Other Transaction (OT) authority pursuant to 42 USC 242c. As such, assessment activities conducted in furtherance of an award or awards are considered competitive in the same manner as a Broad Agency Announcement (BAA) or Commercial Solutions Opening (CSO), and solutions will be assessed independently of one another primarily for technical merit. The procedures outlined in this open call are considered by CDC to satisfy the reasonable effort to obtain competition.

Part 2 - Problem Statement

Influenza A(H5) is a highly pathogenic virus that causes severe respiratory illness in humans, with a high mortality rate. The World Health Organization (WHO) has identified this virus as a major public health concern, as it has the potential to cause a global pandemic. The current testing capabilities for Influenza A(H5) are limited, which could hinder efforts to contain and control the virus in the event of an outbreak. Testing capable of generating Influenza A(H5) specific diagnosis is currently limited to CDC and some state public health laboratories. This limitation could prove to be problematic in the event of an H5 epidemic or pandemic in the United States or internationally. The amount of testing required in the event of an emergency may quickly exceed the capacity to test at public health laboratories, both domestically and internationally.

The Challenge:

The CDC National Center for Immunization and Respiratory Diseases (NCIRD) Influenza Division (ID) seeks to increase diagnostic test availability for influenza A(H5) assays required to support response efforts in the event of an outbreak. The primary challenge affecting this effort is the limited commercial availability and accessibility of diagnostic tests for Influenza A(H5). Currently, the only public health laboratories in the U.S. equipped to test for this virus are CDC and state and jurisdictional public health laboratories with access to the CDC A(H5) assay. This poses a significant problem as these laboratories may not have the capacity to handle a large number of cases in the event of an H5 epidemic or pandemic. This could result in delays in diagnosing and treating individuals, leading to the further spread of the virus.

Pain Points:

The limited availability and accessibility of diagnostic tests for Influenza A(H5) poses several pain points:

• Delayed diagnosis and treatment: As the current testing capabilities are limited, there is a high risk of delays in diagnosing and treating individuals with Influenza A(H5). This could result in the spread of the virus and potentially increase the mortality rate.

• Overwhelmed capacity of laboratories: In the event of an H5 epidemic or pandemic, the demand for testing may exceed the capacity of the CDC and State Public Health Laboratories. This could lead to delays in testing and results, further exacerbating the spread of the virus.

• Limited access to testing: The current testing capabilities for Influenza A(H5) are limited to certain laboratories, making it difficult for individuals in remote or underserved areas to get tested. This could result in undiagnosed cases and further spread of the virus.

Part 3 - Desired Solution

CDC requires design and validation of a Laboratory Developed Test (LDT) ready for U.S. Food and Drug Administration (FDA) regulatory approval (via the standard approval or Emergency Use Authorization (EUA) process. The LDT must be a Nucleic Acid Amplification Test (NAAT) diagnostic kit capable of detecting and differentiating H5 from seasonal influenza subtypes. Upon regulatory approval, performers must be able to manufacture test kits to support testing of a baseline of 1,000,000 unique samples and the ability to scale-up manufacturing efficiently.

Test design should be performed to follow an appropriate diagnostic testing algorithm: 1) by coupling an H5 assay design with an existing A/B typing assays and seasonal virus subtyping assays; 2) developed with typing/seasonal virus subtyping assay components; 3) an H5-only assay may be considered if there is limited intended use for specific populations, such as persons with known exposures to animals infected with A(H5) virus.

To support test design and validation, CDC will provide the following materials to performers:

1. Control material: inactivated virus, attenuated virus (e.g., Candidate Vaccine Virus (CVV) or synthetic Ribonucleic Acid (RNA));

2. Two of CDC's H5 Diagnostic kits for use as a comparator assay;

3. License to CDC H5 In Vitro Diagnostics (IVD) assay design.

Ideally, all tasks undertaken pursuant to negotiated agreement(s) will be fully completed between 11/01/2024 and 12/31/2024.

Solution Provider Operational Capabilities:

• Ability to conduct research and development for new diagnostic tests for Influenza A(H5);

• Expertise in molecular biology and virology to understand the genetic makeup of the virus and design appropriate tests;

• Access to testing laboratories with specialized high-throughput testing equipment;

• Familiarity with regulatory requirements for diagnostic test development and approval, including proven track record for development of an FDA approved assay;

• Knowledge of current market trends and customer needs for Influenza A(H5) diagnostic tests;

• Ability to collaborate with other government agencies, academic institutions, and private companies for knowledge sharing and resource pooling;

• Demonstrated capacity to manage and analyze large amounts of data related to diagnostic testing;

• Experience in designing and conducting clinical trials to validate the effectiveness of new diagnostic tests;

• Existing supply chain logistics and distribution channels for wide-scale deployment of diagnostic tests;

• Ability to adapt and update diagnostic tests as the virus mutates or new strains emerge;

• Experience with biosafety protocols and procedures for handling and testing potentially hazardous samples;

• Capability to provide training and support for healthcare professionals on how to use and interpret the diagnostic tests;

• Experience in cost management and budgeting for the development and production of diagnostic tests;

• Capacity to scale up production of IVD tests in response to a potential outbreak or pandemic situation;

• Ability to comply with ethical and legal guidelines for the development and use of diagnostic tests;

• Capability to produce one or more tests ready for a) commercialization and b) FDA pre-emergency use authorization no later than 12/31/2024;

• Ability to open source or share intellectual property and/or data rights that will allow

CDC to engage multiple manufacturers to scale-up production in the event of outbreak(s);

• Ability to accurately differentiate between Influenza A(H5) and other respiratory illnesses.

Example Milestones:

The milestones identified below are provided as examples only. Solution Providers may add to, remove from, or replace the milestone chart provided in this announcement as appropriate to reflect a particular solution or anticipated timeline.

Milestone Event Deliverables Estimated Completion Date Agreement(s) Issued N/A 08/01/2024 Project Initiation Kickoff 08/05/2024

Project Planning Planning and Management Plan 08/12/2024

Project Planning

Test Production Plan (including Timeline, Milestones, Quality, Data, and Resources) 08/16/2024

Project Implementation Prototype Development Completed 10/01/2024

Project Validation

Validation Completed (including, at a minimum, sensitivity, specificity, contrived clinical specimen testing data, quality control and assurance) 10/30/2024

Project Approval and Deliverable

LDT or Emergency Use Authorization (EUA) Test developed and approved by FDA 12/31/2024

Part 4 - Submission Instructions

This announcement identifies a multiple-round, competitive assessment process to identify solutions that best solve CDC problem(s).

Although there are a multitude of great ideas, the government has limited resources for experimentation and piloting purposes. This process enables us to focus on the few ideas and solutions that have technical merit and take action with a pilot project award. As a result, not all Solution Providers will participate in all rounds or obtain a pilot project agreement with the government.

We also need flexibility as we learn new things during new assessment activities. The government may skip or combine rounds as necessary to collect and assess information as it relates to proposed solutions. Further, the government may go back to earlier rounds with clarifications and additional requests as necessary to identify successful solutions that will meet intended pilot project objectives. Finally, the government may initiate steps toward a prototype project award at any round.

Round 1 – Concept paper Submission:

If you have a solution that addresses the problem description, we would love to hear about it! Submit a brief concept paper (2-3 pages) for us to assess. CDC and select subject matter experts may invite those that have the highest potential to solving the problem to Round 2.

WHAT DO I SUBMIT IN ROUND 1?

Submit a 2-3 page concept paper by the deadline answering the following questions and instructions. The concept paper should be clear yet concise with relevant and convincing arguments to support your solution. We will not dictate format, but ask you answer the prompts in the order provided.

1. PROBLEM ALIGNMENT: Provide a description of your solution and how your solution is aligned to address the published problem(s).

2. VALUE PROPOSITION: Why is your solution the best approach from a technical, business, or operational perspective?

3. OPERATIONAL IMPACT: How will your solution support CDC’s mission to protect the American people from health, safety, and security threats?

4. POTENTIAL FOR COMMERCIALIZATION AND/OR OPEN

MANUFACTURING: Describe your strategy for commercializing diagnostic tests in other federal agencies and/or private sector markets. Expound on whether your solution leverages open manufacturing or open source principles to support broad testing availability.

5. ROUGH ORDER OF MAGNITUDE: Provide the estimated Rough Order of

Magnitude (ROM) for your solution. Provide the total ROM and the ROM for each planned milestone.

Solution Providers shall submit concept papers via email to mcrow@cdc.gov no later than 11:59 PM Eastern on Monday, June 24th, 2024 in order to be considered for further evaluation. The government does not anticipate the ability to consider late concept paper submissions.

The subject line for concept paper email submissions shall be formatted as follows:

“[Solution Provider Name] Concept Paper Submission for Notice ID 75D301-24-CTI-00001”

Round 2 – Oral Presentation:

This is your chance to pitch your best proof of concept to a government panel.

Participants will have 15 minutes to present and 30 minutes for questions from the panel.

Questions will be relevant to the information provided in the pitch and may differ among presenters. There is no formal agenda or schedule to the pitch outside of the time constraint. The Presenter has complete control over the structure and format of the 15-minute pitch and is encouraged to focus on the value proposition the proof of concept will provide to the government. Pitches should be able to be understood by a technical and non-technical panel audience. Any organizational descriptions and introductory company remarks should be kept to a bare minimum or not at all. It is highly critical that the presenter demonstrate it understands the capability gap and how the proof of concept will solve the problem. If invited to this phase, mailto:mcrow@cdc.gov additional logistical information (e.g., time and date) will be provided separate from this open call.

Project Award:

The government reserves the right to make one, some, or no agreements based on the results of any round. Successfully negotiated awards are intended to be Other Transaction Agreements under 42 USC 242c. An award under 42 USC 242c may result in a subsequent award of a follow-on manufacturing and/or distribution agreement without additional competition based on successful prototype completion.

The government further reserves the right to consider solutions submitted under this open call for Federal Acquisition Regulation (FAR)-based awards under FAR Part 15. The government will not issue grants or cooperative agreements as a result of this open call.

Part 5 – Communication and Notices

Communication with CDC:

Solution Providers are instructed to contact ONLY the CDC Office of Acquisition Services point(s) of contact listed below in connection with any aspect of this open call:

Michael Crow CDC Office of Acquisition Services (OAS) Email: mcrow@cdc.gov Telephone: 770-488-3208

Feedback:

We care about transparency and providing timely feedback to help you improve your offerings. If you are not chosen for a subsequent round(s), we will make our best efforts to notify you in writing as soon as practical.

If you are invited to any round, subsequent round(s), or a return to earlier round(s), we will notify you via email with details and instructions on what information we are looking to assess. We are not able to provide instructions in advance due to the individual variance between problem sets and unique circumstances that may impact individual projects.

Assessors:

Non-CDC subject matter expert (SME) assessors may be used any assessment activity.

Such assessors will be operating at the direction of CDC and through signed non-disclosure agreements (NDAs). CDC understands that information provided in response to this announcement is presented in confidence and it agrees to protect such information from unauthorized disclosure to extent required by law. Your participation in any round of assessment under this open call indicates concurrence with the use of Non-CDC SME judges.

mailto:mcrow@cdc.gov