HHS awards $6.7M contract for sepsis detection R&D, aiming for early, ubiquitous identification

Contract Overview

Contract Amount: $6,702,732 ($6.7M)

Contractor: AD Astra Diagnostics, Inc.

Awarding Agency: Department of Health and Human Services

Start Date: 2024-09-22

End Date: 2028-12-17

Contract Duration: 1,547 days

Daily Burn Rate: $4.3K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 99

Pricing Type: FIRM FIXED PRICE

Sector: R&D

Official Description: AD ASTRA DIAGNOSTICS, INC. (PLUS) &D FOR CLIA-WAIVED UBIQUITOUS EARLY SEPSIS DETECTION, SEVERITY IN AMBULANCE, PRE-HOSPITAL, POST- DISCHARGE AOI #02+: INFECTION SEVERITY AND SOLVING SEPSIS

Place of Performance

Location: MORRISVILLE, WAKE County, NORTH CAROLINA, 27560

State: North Carolina Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $6.7 million to AD ASTRA DIAGNOSTICS, INC. for work described as: AD ASTRA DIAGNOSTICS, INC. (PLUS) &D FOR CLIA-WAIVED UBIQUITOUS EARLY SEPSIS DETECTION, SEVERITY IN AMBULANCE, PRE-HOSPITAL, POST- DISCHARGE AOI #02+: INFECTION SEVERITY AND SOLVING SEPSIS Key points: 1. Contract focuses on innovative research and development for sepsis detection, a critical public health concern. 2. The award is a definitive contract, suggesting a long-term relationship for specialized R&D services. 3. Research and Development in Biotechnology is the primary NAICS code, indicating a focus on scientific advancement. 4. The contract's duration of over 4 years highlights a commitment to achieving the research objectives. 5. The firm fixed-price structure aims to control costs for the government. 6. The contract was awarded under full and open competition, suggesting a robust bidding process.

Value Assessment

Rating: good

The contract value of $6.7 million for R&D in biotechnology is within a reasonable range for specialized research projects. Benchmarking against similar contracts for early disease detection technologies would provide further context. The firm fixed-price structure suggests an effort to manage costs effectively, but the ultimate value will depend on the successful development and validation of the sepsis detection technology.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded through full and open competition, indicating that multiple vendors had the opportunity to bid. This process is designed to foster a competitive environment, potentially leading to better pricing and innovative solutions. The number of bids received (99) suggests significant interest and a healthy level of competition for this R&D effort.

Taxpayer Impact: Full and open competition generally benefits taxpayers by driving down costs and encouraging the best possible solutions to be presented, maximizing the return on investment for public funds.

Public Impact

The primary beneficiaries are patients who could benefit from earlier and more accurate sepsis detection, potentially leading to improved health outcomes and reduced mortality. The services delivered involve research and development of a novel diagnostic tool for sepsis. The geographic impact is national, as improved sepsis detection can be applied across healthcare settings. Workforce implications may include the need for skilled researchers and technicians in biotechnology and diagnostics.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

The success of the R&D is contingent on achieving specific technological milestones within the contract period.
The long-term adoption and integration of the developed technology into clinical practice present a potential challenge.
Ensuring the accuracy and reliability of the sepsis detection method across diverse patient populations will be critical.

Positive Signals

The focus on a critical health issue like sepsis demonstrates a commitment to public health advancement.
The significant number of bids received indicates strong market interest and potential for innovative solutions.
The definitive contract structure suggests a strategic partnership for a complex R&D undertaking.

Sector Analysis

This contract falls within the Biotechnology Research and Development sector, a rapidly evolving field focused on leveraging biological processes for technological advancement. The market for diagnostic tools, particularly for life-threatening conditions like sepsis, is substantial and driven by the need for faster, more accurate, and accessible testing. Comparable spending in this sector often involves significant investment in innovation, with contracts ranging from early-stage research to clinical validation and market entry.

Small Business Impact

The contract was awarded under full and open competition and does not indicate any specific small business set-asides. While large R&D projects can sometimes involve subcontracting opportunities for specialized small businesses, the primary awardee is Ad Astra Diagnostics, Inc. Further analysis would be needed to determine if subcontracting plans include provisions for small business participation.

Oversight & Accountability

Oversight for this contract will likely be managed by the Office of Assistant Secretary for Preparedness and Response (ASPR) within HHS. Accountability measures will be tied to the achievement of research milestones and deliverables outlined in the contract. Transparency is generally maintained through contract award databases and public reporting, though specific R&D progress may be proprietary.

Related Government Programs

Biotechnology Research and Development
Infectious Disease Research
Diagnostic Technology Development
Public Health Initiatives
Sepsis Management Programs

Risk Flags

Research and Development Timeline Risk
Technological Feasibility Risk
Market Adoption Risk
Regulatory Approval Risk

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $6.7 million to AD ASTRA DIAGNOSTICS, INC.. AD ASTRA DIAGNOSTICS, INC. (PLUS) &D FOR CLIA-WAIVED UBIQUITOUS EARLY SEPSIS DETECTION, SEVERITY IN AMBULANCE, PRE-HOSPITAL, POST- DISCHARGE AOI #02+: INFECTION SEVERITY AND SOLVING SEPSIS

Who is the contractor on this award?

The obligated recipient is AD ASTRA DIAGNOSTICS, INC..

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 $6.7 million.

What is the period of performance?

Start: 2024-09-22. End: 2028-12-17.

What is the specific scientific approach Ad Astra Diagnostics, Inc. will use for early sepsis detection?

The provided data does not detail the specific scientific methodology Ad Astra Diagnostics, Inc. will employ for early sepsis detection. The contract AOI (Area of Interest) #02+ mentions 'INFECTION SEVERITY AND SOLVING SEPSIS' and 'UBIQUITOUS EARLY SEPSIS DETECTION,' suggesting a focus on identifying and quantifying sepsis severity in various settings, including pre-hospital and post-discharge. Further details would likely be found in the technical proposal submitted by the contractor or in subsequent project reports. The research aims to address detection in ambulance, pre-hospital, and post-discharge scenarios, implying a need for portable or easily deployable diagnostic solutions.

How does the $6.7 million contract value compare to typical R&D investments in sepsis detection technology?

The $6.7 million contract value for R&D in sepsis detection is a significant investment, but its comparability to other R&D projects depends heavily on the scope, duration, and technological maturity targeted. Early-stage research and proof-of-concept studies might cost less, while contracts encompassing extensive clinical trials, regulatory approvals, and manufacturing scale-up could be substantially higher. Given this is a definitive contract with a duration of over four years, it suggests a comprehensive R&D effort. Benchmarking against similar government-funded or venture-capital-backed initiatives in advanced diagnostics would provide a clearer picture of whether this represents a high, average, or low investment for the intended outcomes.

What are the key performance indicators (KPIs) for this contract, and how will success be measured?

The provided data does not explicitly list the Key Performance Indicators (KPIs) for this contract. However, for a research and development contract focused on sepsis detection, success would likely be measured against specific technical milestones. These could include metrics related to the sensitivity and specificity of the diagnostic test, the speed of detection, the portability or usability of the device in pre-hospital or post-discharge settings, and the ability to differentiate sepsis severity. The contract's duration and firm fixed-price nature imply that adherence to a development timeline and the successful achievement of defined research objectives will be critical for performance evaluation.

What is Ad Astra Diagnostics, Inc.'s track record in developing and commercializing diagnostic technologies, particularly for infectious diseases?

Information regarding Ad Astra Diagnostics, Inc.'s specific track record in developing and commercializing diagnostic technologies, especially for infectious diseases, is not detailed in the provided data. As a recipient of a definitive contract for R&D, it is implied that the company possesses relevant expertise and capabilities. A thorough assessment would require reviewing the company's past performance on similar contracts, its portfolio of existing products or patents, any prior regulatory approvals (e.g., FDA), and its history of successful technology transfer or commercialization. Further investigation into the company's background and previous projects would be necessary to evaluate its experience.

What is the potential impact of this contract on the broader effort to combat sepsis in the United States?

This contract has the potential to significantly impact the broader effort to combat sepsis by advancing the development of early and ubiquitous detection methods. Sepsis is a leading cause of death in hospitals, and rapid diagnosis is crucial for effective treatment. If Ad Astra Diagnostics, Inc. successfully develops a technology that allows for timely and accurate identification of sepsis, particularly in pre-hospital or post-discharge settings, it could lead to faster initiation of treatment, reduced hospital stays, lower mortality rates, and decreased healthcare costs associated with sepsis management. The focus on 'solving sepsis' indicates a strategic alignment with national public health priorities.

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: BASIC RESEARCH

Solicitation ID: BAA-22-100-SOL-00003

Offers Received: 99

Pricing Type: FIRM FIXED PRICE (J)

Evaluated Preference: NONE

Contractor Details

Address: 1001 AVIATION PKWY STE 400, MORRISVILLE, NC, 27560

Business Categories: Category Business, Corporate Entity Not Tax Exempt, Not Designated a Small Business, Special Designations, U.S.-Owned Business

Financial Breakdown

Contract Ceiling: $14,309,222

Exercised Options: $6,702,732

Current Obligation: $6,702,732

Actual Outlays: $2,518,919

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: NO

Timeline