HHS Awards $7.6M for Rapid Antibiotic Susceptibility Diagnostic Test Development

Contract Overview

Contract Amount: $7,625,622 ($7.6M)

Contractor: Biofire Defense LLC

Awarding Agency: Department of Health and Human Services

Start Date: 2022-09-30

End Date: 2025-12-17

Contract Duration: 1,174 days

Daily Burn Rate: $6.5K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 1

Pricing Type: FIRM FIXED PRICE

Sector: R&D

Official Description: THE OVERALL OBJECTIVE OF THIS CONTRACT IS TO ADVANCE THE DEVELOPMENT OF THE REVEAL RAPID AST SYSTEM AS AN ANTIBIOTIC SUSCEPTIBILITY DIAGNOSTIC TEST TYPE OF COUNTERMEASURE TO DETERMINE THE TREATMENT FOR LIFE THREATENING URGENT INFECTIONS FROM PATIENT

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 $7.6 million to BIOFIRE DEFENSE LLC for work described as: THE OVERALL OBJECTIVE OF THIS CONTRACT IS TO ADVANCE THE DEVELOPMENT OF THE REVEAL RAPID AST SYSTEM AS AN ANTIBIOTIC SUSCEPTIBILITY DIAGNOSTIC TEST TYPE OF COUNTERMEASURE TO DETERMINE THE TREATMENT FOR LIFE THREATENING URGENT INFECTIONS FROM PATIENT Key points: 1. Focus on developing a critical diagnostic test for life-threatening infections. 2. BioFire Defense LLC, a single awardee, highlights potential concentration risk. 3. The contract is for Research and Development in Biotechnology. 4. Firm Fixed Price contract type aims to control costs.

Value Assessment

Rating: good

The $7.6M award for R&D appears reasonable for advancing a novel diagnostic. Benchmarking against similar advanced diagnostic development contracts would provide further context on pricing efficiency.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under full and open competition, suggesting a competitive process for selecting the best approach. However, it is a sole awardee contract, which warrants monitoring for potential future sole-source actions.

Taxpayer Impact: The investment aims to improve patient outcomes and potentially reduce healthcare costs associated with prolonged or ineffective treatments for urgent infections.

Public Impact

Accelerates development of a crucial diagnostic tool for urgent infections. Potential to improve patient treatment decisions and reduce antibiotic resistance. Enhances national preparedness for public health emergencies.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Positive Signals

Sector Analysis

This contract falls under Research and Development in Biotechnology, focusing on advanced diagnostics. Spending in this sector is crucial for public health preparedness and innovation, with significant government investment often seen in areas like infectious disease countermeasures.

Small Business Impact

The data indicates this is a sole awardee contract to BioFire Defense LLC. There is no explicit information regarding small business participation or subcontracting goals within this specific award.

Oversight & Accountability

The contract is managed by the Department of Health and Human Services, Office of Assistant Secretary for Preparedness and Response. Oversight will be critical to ensure milestones are met and funds are used effectively for the intended R&D objectives.

Related Government Programs

Risk Flags

Tags

research-and-development-in-biotechnolog, department-of-health-and-human-services, ut, definitive-contract, 1m-plus

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $7.6 million to BIOFIRE DEFENSE LLC. THE OVERALL OBJECTIVE OF THIS CONTRACT IS TO ADVANCE THE DEVELOPMENT OF THE REVEAL RAPID AST SYSTEM AS AN ANTIBIOTIC SUSCEPTIBILITY DIAGNOSTIC TEST TYPE OF COUNTERMEASURE TO DETERMINE THE TREATMENT FOR LIFE THREATENING URGENT INFECTIONS FROM PATIENT

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 $7.6 million.

What is the period of performance?

Start: 2022-09-30. End: 2025-12-17.

What is the projected timeline for achieving key development milestones for the REVEAL Rapid AST System?

The contract end date is December 17, 2025, suggesting a multi-year development cycle. Specific milestone timelines would typically be detailed in the contract's statement of work. Regular progress reports and reviews by HHS are expected to track adherence to these timelines and ensure the project stays on track for successful development.

How will the effectiveness of the diagnostic test be validated post-development to ensure clinical utility?

Post-development validation is crucial. While not detailed here, it would likely involve rigorous clinical trials and performance evaluations against established standards. HHS oversight should ensure a robust validation plan is executed, potentially involving collaboration with clinical laboratories and public health agencies to confirm the test's accuracy and impact on treatment decisions.

What are the potential long-term cost savings associated with the successful implementation of this diagnostic test?

Successful implementation could lead to significant long-term cost savings by enabling faster, more accurate treatment selection. This reduces the need for broad-spectrum antibiotics, minimizes hospital stays due to ineffective treatments, and combats the rise of antibiotic resistance, which carries substantial economic and health burdens.

Industry Classification

NAICS: Professional, Scientific, and Technical ServicesScientific Research and Development ServicesResearch and Development in Biotechnology (except Nanobiotechnology)

Product/Service Code: RESEARCH AND DEVELOPMENTN – 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: FIRM FIXED PRICE (J)

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: $38,721,993

Exercised Options: $7,625,622

Current Obligation: $7,625,622

Actual Outlays: $7,625,622

Subaward Activity

Number of Subawards: 1

Total Subaward Amount: $8,956,000

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: YES

Timeline

Start Date: 2022-09-30

Current End Date: 2025-12-17

Potential End Date: 2025-12-17 00:00:00

Last Modified: 2025-12-18

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