HHS Awards $31M Contract to Luminex for Point-of-Care Diagnostics Amid Limited Pharmacy Testing Capacity

Contract Overview

Contract Amount: $30,954,000 ($31.0M)

Contractor: Diasorin Molecular, LLC

Awarding Agency: Department of Health and Human Services

Start Date: 2022-09-30

End Date: 2026-06-30

Contract Duration: 1,369 days

Daily Burn Rate: $22.6K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 1

Pricing Type: FIRM FIXED PRICE

Sector: R&D

Official Description: IT IS ESTIMATED THAT JUST 5,000 US PHARMACIES OFFER POINT-OF-CARE (POC) MOLECULAR DIAGNOSTICS WITH THE OTHER 83,000 LOCATIONS ONLY OFFERING SAMPLE COLLECTION / SEND OUT SERVICES OR PROVIDING NO TESTING AT ALL. IN THIS EFFORT, LUMINEX CORPORATION, A

Place of Performance

Location: CYPRESS, ORANGE County, CALIFORNIA, 90630

State: California Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $31.0 million to DIASORIN MOLECULAR, LLC for work described as: IT IS ESTIMATED THAT JUST 5,000 US PHARMACIES OFFER POINT-OF-CARE (POC) MOLECULAR DIAGNOSTICS WITH THE OTHER 83,000 LOCATIONS ONLY OFFERING SAMPLE COLLECTION / SEND OUT SERVICES OR PROVIDING NO TESTING AT ALL. IN THIS EFFORT, LUMINEX CORPORATION, A Key points: 1. Limited pharmacy adoption of point-of-care diagnostics (5,000 out of 88,000 locations) highlights a critical gap. 2. The contract aims to expand diagnostic capabilities, potentially improving public health response. 3. Competition is noted as 'FULL AND OPEN', suggesting a competitive bidding process. 4. The sector is R&D in Biotechnology, a critical area for health innovation.

Value Assessment

Rating: good

The contract value of $30.95 million over approximately 3.7 years appears reasonable for specialized biotechnology R&D. Benchmarking against similar contracts for diagnostic development and deployment is needed for a definitive assessment.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under full and open competition, indicating multiple vendors had the opportunity to bid. This method is expected to foster competitive pricing and ensure the government receives the best value.

Taxpayer Impact: By increasing point-of-care diagnostic capabilities, this contract aims to improve public health preparedness and response, potentially reducing broader healthcare costs and improving patient outcomes.

Public Impact

Enhances national capacity for rapid disease detection and response. Supports the development and deployment of advanced molecular diagnostic tools. Could lead to more accessible and faster testing for various health conditions. Aims to address the current disparity in pharmacy diagnostic service offerings.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Limited current adoption of POC diagnostics in pharmacies.
Contract duration extends over several years, requiring ongoing monitoring.
Dependence on a single contractor (Luminex) for this specific effort.

Positive Signals

Awarded under full and open competition.
Focus on a critical area of public health preparedness.
Potential for significant improvement in diagnostic accessibility.

Sector Analysis

The contract falls within the Biotechnology (except Nanobiotechnology) R&D sector, a field crucial for developing innovative healthcare solutions. Spending in this sector is often high due to the complex and lengthy nature of research and development.

Small Business Impact

The provided data does not indicate whether small businesses were involved in this contract, either as prime contractors or subcontractors. Further analysis would be needed to assess small business participation.

Oversight & Accountability

The Department of Health and Human Services, specifically the Office of Assistant Secretary for Preparedness and Response, is responsible for this contract. Oversight will be critical to ensure milestones are met and funds are used effectively.

Related Government Programs

Research and Development in Biotechnology (except Nanobiotechnology)
Department of Health and Human Services Contracting
Office of Assistant Secretary for Preparedness and Response Programs

Risk Flags

Limited current adoption of point-of-care diagnostics in pharmacies.
Potential for delays in R&D and deployment.
Reliance on specific technology platforms.
Ensuring equitable access across diverse pharmacy settings.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $31.0 million to DIASORIN MOLECULAR, LLC. IT IS ESTIMATED THAT JUST 5,000 US PHARMACIES OFFER POINT-OF-CARE (POC) MOLECULAR DIAGNOSTICS WITH THE OTHER 83,000 LOCATIONS ONLY OFFERING SAMPLE COLLECTION / SEND OUT SERVICES OR PROVIDING NO TESTING AT ALL. IN THIS EFFORT, LUMINEX CORPORATION, A

Who is the contractor on this award?

The obligated recipient is DIASORIN MOLECULAR, 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 $31.0 million.

What is the period of performance?

Start: 2022-09-30. End: 2026-06-30.

What is the specific technology Luminex Corporation is developing or deploying under this contract, and how does it address the limited point-of-care testing capacity in pharmacies?

The contract likely involves Luminex's existing or new molecular diagnostic platforms designed for point-of-care use. This could include rapid test kits for infectious diseases or other conditions, enabling pharmacies to perform tests on-site rather than sending samples to labs. The goal is to overcome the current bottleneck where most pharmacies only offer sample collection, thereby increasing testing accessibility and speed for patients.

Given the 'full and open competition' award, what were the key performance indicators and evaluation criteria used to select Luminex Corporation, and how do they mitigate risks associated with R&D con

Key performance indicators likely included technical capability, proposed timeline, cost-effectiveness, and demonstrated experience in molecular diagnostics. Evaluation criteria would have focused on Luminex's ability to meet stringent performance requirements, manage project risks, and deliver a viable product within budget. Mitigation of R&D risks involves phased payments tied to milestones, clear deliverables, and robust government oversight to ensure progress and accountability.

How will the success of this contract, measured by increased point-of-care diagnostics in pharmacies, be tracked and what is the anticipated impact on public health response times?

Success will be tracked through metrics such as the number of pharmacies adopting the technology, the volume of tests performed, and user feedback. The anticipated impact is a significant reduction in diagnostic turnaround times, enabling faster treatment decisions and containment of outbreaks. This improved responsiveness is crucial for public health emergencies, allowing for quicker interventions and potentially saving lives.

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-SOL-00003

Offers Received: 1

Pricing Type: FIRM FIXED PRICE (J)

Evaluated Preference: NONE

Contractor Details

Address: 11331 VALLEY VIEW ST, CYPRESS, CA, 90630

Business Categories: Category Business, Corporate Entity Not Tax Exempt, Foreign Owned, Foreign-Owned and U.S.-Incorporated Business, Manufacturer of Goods, Not Designated a Small Business, Special Designations

Financial Breakdown

Contract Ceiling: $30,954,000

Exercised Options: $30,954,000

Current Obligation: $30,954,000

Actual Outlays: $30,454,000

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: NO

Timeline