HHS awards $22M contract for advanced flu panel development, aiming for faster diagnostics

Contract Overview

Contract Amount: $21,982,653 ($22.0M)

Contractor: Biofire Defense LLC

Awarding Agency: Department of Health and Human Services

Start Date: 2023-09-29

End Date: 2029-07-31

Contract Duration: 2,132 days

Daily Burn Rate: $10.3K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 1

Pricing Type: COST PLUS FIXED FEE

Sector: R&D

Official Description: THE OVERALL OBJECTIVE OF THIS CONTRACT IS TO ADVANCE THE DEVELOPMENT OF THE BIOFIRE EMERGING FLU PANEL AS A NUCLEIC ACID DETECTION PANEL FOR USE ON THE EASY-TO-USE BIOFIRE FILMARRAY TORCH AND BIOFIRE SPOTFIRE PLATFORMS.

Place of Performance

Location: SALT LAKE CITY, SALT LAKE County, UTAH, 84107

State: Utah Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $22.0 million to BIOFIRE DEFENSE LLC for work described as: THE OVERALL OBJECTIVE OF THIS CONTRACT IS TO ADVANCE THE DEVELOPMENT OF THE BIOFIRE EMERGING FLU PANEL AS A NUCLEIC ACID DETECTION PANEL FOR USE ON THE EASY-TO-USE BIOFIRE FILMARRAY TORCH AND BIOFIRE SPOTFIRE PLATFORMS. Key points: 1. Contract focuses on developing a nucleic acid detection panel for emerging flu strains. 2. The technology aims to leverage existing BioFire platforms for ease of use. 3. Research and Development in Biotechnology is the primary sector for this award. 4. The contract duration extends over several years, indicating a long-term development goal. 5. This award represents a significant investment in public health preparedness. 6. The fixed-fee structure on a cost-plus award type suggests a focus on achieving specific development milestones.

Value Assessment

Rating: good

The contract value of $21.98 million for a multi-year R&D effort in biotechnology appears reasonable, especially considering the specialized nature of developing diagnostic panels for emerging infectious diseases. Benchmarking against similar contracts for advanced diagnostic development would provide a more precise value assessment, but the scope suggests a significant undertaking. The Cost Plus Fixed Fee (CPFF) structure implies that the contractor is incentivized to control costs while achieving defined objectives, which can be a good value proposition if milestones are met efficiently.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under full and open competition, indicating that multiple qualified vendors had the opportunity to bid. This competitive process is expected to drive innovation and ensure fair pricing. The number of bidders is not specified, but the open competition suggests a healthy market for this type of specialized R&D.

Taxpayer Impact: Full and open competition generally benefits taxpayers by fostering a competitive environment that can lead to lower prices and higher quality services or products.

Public Impact

The primary beneficiaries are public health agencies and healthcare providers who will gain access to advanced diagnostic tools. The contract will deliver an improved nucleic acid detection panel for emerging flu strains. The development aims to enhance the speed and accuracy of flu diagnosis. This advancement could have significant implications for pandemic preparedness and response efforts. The project supports the development of critical medical technologies within the biotechnology sector.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Potential for cost overruns in R&D projects if not closely managed.
Dependence on the contractor's technical expertise and successful development outcomes.
The long duration of the contract could introduce risks related to evolving technology or changing public health priorities.

Positive Signals

Awarded under full and open competition, suggesting a robust market and potential for innovation.
Focus on developing advanced diagnostic tools for emerging threats aligns with critical public health needs.
The use of established BioFire platforms indicates a strategy to build upon existing, proven technology.
The contract aims to deliver a tangible product (diagnostic panel) with clear application.

Sector Analysis

This contract falls within the Biotechnology R&D sector, a rapidly evolving field critical for public health and national security. The market for diagnostic tools, particularly for infectious diseases, is substantial and driven by continuous innovation and the need for rapid response to outbreaks. This award contributes to the government's investment in advanced medical countermeasures and diagnostic capabilities, aiming to stay ahead of emerging health threats.

Small Business Impact

The contract was awarded under full and open competition and does not indicate any specific small business set-aside. However, the prime contractor, BioFire Defense LLC, may engage small businesses as subcontractors for specialized services or components, contributing to the broader small business ecosystem within the biotechnology supply chain.

Oversight & Accountability

Oversight for this contract will likely be managed by the Department of Health and Human Services (HHS), specifically the Office of Assistant Secretary for Preparedness and Response (ASPR). The Cost Plus Fixed Fee (CPFF) award type necessitates close monitoring of costs and progress towards defined milestones. Transparency will be maintained through regular reporting requirements from the contractor and potential reviews by HHS program officials and potentially the HHS Office of Inspector General.

Related Government Programs

National Institutes of Health (NIH) Research Grants
Centers for Disease Control and Prevention (CDC) Diagnostic Development Programs
Department of Defense (DoD) Medical Countermeasures Initiatives

Risk Flags

Long contract duration may expose project to technological obsolescence or shifting priorities.
R&D projects inherently carry risk of technical challenges and non-completion.
Cost-plus contract type requires diligent oversight to ensure cost efficiency.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $22.0 million to BIOFIRE DEFENSE LLC. THE OVERALL OBJECTIVE OF THIS CONTRACT IS TO ADVANCE THE DEVELOPMENT OF THE BIOFIRE EMERGING FLU PANEL AS A NUCLEIC ACID DETECTION PANEL FOR USE ON THE EASY-TO-USE BIOFIRE FILMARRAY TORCH AND BIOFIRE SPOTFIRE PLATFORMS.

Who is the contractor on this award?

The obligated recipient is BIOFIRE DEFENSE LLC.

Which agency awarded this contract?

Awarding agency: Department of Health and Human Services (Office of Assistant Secretary for Preparedness and Response).

What is the total obligated amount?

The obligated amount is $22.0 million.

What is the period of performance?

Start: 2023-09-29. End: 2029-07-31.

What is the specific technical innovation this contract aims to achieve beyond existing flu diagnostics?

This contract aims to advance the development of the BioFire Emerging Flu Pan-el, a nucleic acid detection panel specifically designed for use on the BioFire FilmArray Torch and BioFire SpotFire platforms. The innovation lies in creating a more comprehensive and potentially faster diagnostic tool capable of detecting a wider range of emerging flu strains. This goes beyond standard flu tests by focusing on novel or less common strains that might pose a greater public health risk and require rapid identification for effective containment and treatment strategies. The goal is to integrate this advanced detection capability seamlessly into existing, user-friendly diagnostic systems.

How does the Cost Plus Fixed Fee (CPFF) structure incentivize the contractor for this R&D project?

The Cost Plus Fixed Fee (CPFF) structure is common for research and development contracts where the exact costs are difficult to predict. In this arrangement, the government reimburses the contractor for all allowable costs incurred during the project, plus a predetermined fixed fee. This fee represents the contractor's profit. The incentive for the contractor is to complete the project efficiently and within the estimated cost range to maximize their return on investment, as the fee is fixed regardless of the final cost. However, it also requires robust government oversight to ensure costs are reasonable and allocable to the contract objectives. For taxpayers, it offers a balance between encouraging innovation and managing potential cost escalations.

What are the potential risks associated with the long contract duration (ending in 2029)?

The extended duration of this contract, ending in July 2029, presents several potential risks. Firstly, the field of biotechnology and diagnostic technology is rapidly evolving; by 2029, newer, potentially more effective technologies might emerge, rendering the developed panel less competitive or obsolete. Secondly, public health priorities can shift due to unforeseen events, potentially altering the demand or urgency for this specific diagnostic panel. Thirdly, there's a risk of 'scope creep' or changes in requirements over such a long period, which could lead to cost increases if not managed carefully. Finally, maintaining consistent contractor performance and engagement over multiple years can be challenging.

Can the performance of BioFire Defense LLC on similar contracts be assessed to gauge reliability?

Assessing the performance of BioFire Defense LLC on similar contracts is crucial for understanding their reliability in delivering complex R&D projects. While specific past performance data is not detailed here, BioFire Defense LLC is known for its work in developing diagnostic solutions, particularly for biodefense and emerging infectious diseases. Their existing product lines, such as the FilmArray systems, suggest a track record of successful product development and deployment. A thorough review would involve examining their history with government contracts, including on-time delivery, adherence to budget, quality of deliverables, and responsiveness to government needs in previous R&D or manufacturing efforts.

What is the anticipated impact of this contract on the broader biotechnology R&D sector?

This contract is expected to have a positive impact on the biotechnology R&D sector by stimulating innovation in diagnostic technologies. It validates the market demand for advanced infectious disease diagnostics and encourages further investment in this area. The development of the BioFire Emerging Flu Panel could lead to new intellectual property, publications, and potentially spin-off technologies. Furthermore, it strengthens the capabilities of BioFire Defense LLC and potentially its subcontractors, fostering growth and expertise within the sector. Government funding for such targeted R&D projects often acts as a catalyst, driving advancements that can have broader applications in both public health and commercial markets.

Industry Classification

NAICS: Professional, Scientific, and Technical Services › Scientific Research and Development Services › Research and Development in Biotechnology (except Nanobiotechnology)

Product/Service Code: RESEARCH AND DEVELOPMENT › N – Health R&D Services

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION

Solicitation Procedures: NEGOTIATED PROPOSAL/QUOTE

Solicitation ID: BAA-18-100-SOL-00003

Offers Received: 1

Pricing Type: COST PLUS FIXED FEE (U)

Evaluated Preference: NONE

Contractor Details

Parent Company: Compagnie Merieux Alliance

Address: 79 W 4500 S, SALT LAKE CITY, UT, 84107

Business Categories: Category Business, Corporate Entity Not Tax Exempt, Limited Liability Corporation, Manufacturer of Goods, Not Designated a Small Business, Special Designations, U.S.-Owned Business

Financial Breakdown

Contract Ceiling: $21,982,653

Exercised Options: $21,982,653

Current Obligation: $21,982,653

Actual Outlays: $4,429,009

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: YES

Timeline