HHS awards $25.5M for advanced multi-analyte COVID/Flu test development

Contract Overview

Contract Amount: $25,499,669 ($25.5M)

Contractor: Detect Inc

Awarding Agency: Department of Health and Human Services

Start Date: 2022-01-24

End Date: 2026-10-26

Contract Duration: 1,736 days

Daily Burn Rate: $14.7K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 1

Pricing Type: COST PLUS FIXED FEE

Sector: R&D

Official Description: THIS CONTRACT IS TO ADVANCE THE DEVELOPMENT OF A SECOND-GENERATION, MULTI-ANALYTE MOLECULAR SARS-COV-2 AND INFLUENZA A/B TEST THAT HAS A REDUCED TIME TO RESULT AND INCREASED SENSITIVITY THAT CAN BE USED AT HOME OR A POC SETTING

Place of Performance

Location: GUILFORD, NEW HAVEN County, CONNECTICUT, 06437

State: Connecticut Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $25.5 million to DETECT INC for work described as: THIS CONTRACT IS TO ADVANCE THE DEVELOPMENT OF A SECOND-GENERATION, MULTI-ANALYTE MOLECULAR SARS-COV-2 AND INFLUENZA A/B TEST THAT HAS A REDUCED TIME TO RESULT AND INCREASED SENSITIVITY THAT CAN BE USED AT HOME OR A POC SETTING Key points: 1. Focus on rapid, sensitive at-home/POC molecular testing for SARS-CoV-2 and Influenza A/B. 2. Contract aims to reduce time-to-result and increase sensitivity compared to existing tests. 3. Potential for significant public health impact in managing respiratory illnesses. 4. Research and Development in Physical, Engineering, and Life Sciences sector.

Value Assessment

Rating: good

The contract value of $25.5 million for a 4-year R&D effort appears reasonable given the complexity of developing advanced diagnostic technology. Benchmarking is difficult without specific cost breakdowns, but it aligns with typical R&D investments in the life sciences sector.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under full and open competition, suggesting a robust price discovery process. This method allows for the selection of the most capable offeror at a competitive price.

Taxpayer Impact: Successful development could lead to more accessible and accurate diagnostics, potentially reducing healthcare system strain and improving public health outcomes.

Public Impact

Improved home testing capabilities for common respiratory viruses. Faster diagnosis leading to quicker treatment and reduced spread. Potential for integration into public health surveillance systems. Enhanced preparedness for future pandemics or seasonal outbreaks. Reduced burden on clinical laboratories and healthcare facilities.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Development timelines can be challenging in R&D.
Market adoption of new diagnostic technologies can be slow.
Regulatory approval processes for medical devices.

Positive Signals

Addresses a critical public health need.
Leverages advanced molecular diagnostic technology.
Potential for significant impact on disease management.
Strong government agency backing (HHS).

Sector Analysis

This contract falls within the Research and Development in the Physical, Engineering, and Life Sciences sector. Spending in this area is crucial for innovation in healthcare and diagnostics, with significant government investment aimed at advancing scientific capabilities and addressing national health priorities.

Small Business Impact

While the contract was awarded under full and open competition, there is no specific indication of small business participation in the provided data. Future subcontracting opportunities may exist, but direct award to a prime contractor suggests a focus on established entities for this complex R&D.

Oversight & Accountability

The Department of Health and Human Services, specifically the Office of the Assistant Secretary for Preparedness and Response, is responsible for overseeing this contract. Their role includes ensuring the contractor meets development milestones and delivers on the project's objectives, with accountability for taxpayer funds.

Related Government Programs

Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
Department of Health and Human Services Contracting
Office of Assistant Secretary for Preparedness and Response Programs

Risk Flags

Technological feasibility and R&D risk.
Competition from other advanced diagnostic developers.
Potential for delays in regulatory approval.
Scalability and manufacturing challenges post-development.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $25.5 million to DETECT INC. THIS CONTRACT IS TO ADVANCE THE DEVELOPMENT OF A SECOND-GENERATION, MULTI-ANALYTE MOLECULAR SARS-COV-2 AND INFLUENZA A/B TEST THAT HAS A REDUCED TIME TO RESULT AND INCREASED SENSITIVITY THAT CAN BE USED AT HOME OR A POC SETTING

Who is the contractor on this award?

The obligated recipient is DETECT 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 $25.5 million.

What is the period of performance?

Start: 2022-01-24. End: 2026-10-26.

What is the projected timeline for achieving key development milestones and the final product?

The contract period extends to October 26, 2026, suggesting a multi-year development cycle. Key milestones would typically be defined in the contract's statement of work, with periodic reviews by HHS to track progress. Achieving reduced time-to-result and increased sensitivity are primary objectives that will likely be assessed at various stages of development.

What are the specific performance metrics for sensitivity and time-to-result that the contractor must meet?

The contract likely specifies detailed performance metrics for sensitivity and time-to-result. These would be crucial for evaluating the success of the second-generation test. While not explicitly stated in the summary, these benchmarks are essential for ensuring the developed technology meets the advanced requirements for home or POC use and offers a significant improvement over existing solutions.

How will the effectiveness of the developed test be validated in real-world settings?

Validation in real-world settings would typically involve clinical trials or pilot studies conducted in diverse environments (e.g., home use, clinic POC). The contract should outline the methodology for such validation, including participant recruitment, data collection, and analysis to confirm the test's accuracy, usability, and impact on patient management and public health.

Industry Classification

NAICS: Professional, Scientific, and Technical Services › Scientific Research and Development Services › Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

Product/Service Code: MEDICAL/DENTAL/VETERINARY EQPT/SUPP

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

Address: 530 OLD WHITFIELD ST, GUILFORD, CT, 06437

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

Financial Breakdown

Contract Ceiling: $34,714,763

Exercised Options: $25,499,669

Current Obligation: $25,499,669

Actual Outlays: $25,499,669

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: YES

Timeline