HHS Awards $130M for Roche HIV Viral Load Testing Systems and Reagents

Contract Overview

Contract Amount: $130,151 ($130.2K)

Contractor: Roche Diagnostics Corporation

Awarding Agency: Department of Health and Human Services

Start Date: 2024-08-21

End Date: 2025-08-01

Contract Duration: 345 days

Daily Burn Rate: $377/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 1

Pricing Type: FIRM FIXED PRICE

Sector: Healthcare

Official Description: THE ROCHE COBAS R 4800 AND COBAS R 6800 SYSTEMS AND ASSOCIATED REAGENTS ARE VALIDATED, PEPFAR APPROVED, WHO PREQUALIFIED, AND FDA APPROVED FOR HIV VIRAL LOAD AND EARLY INFANT DIAGNOSIS EID TESTING AND MEETS THE REQUIREMENTS NEEDED TO PERFORM HIV VIRA

Place of Performance

Location: INDIANAPOLIS, MARION County, INDIANA, 46256

State: Indiana Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $130,151.3 to ROCHE DIAGNOSTICS CORPORATION for work described as: THE ROCHE COBAS R 4800 AND COBAS R 6800 SYSTEMS AND ASSOCIATED REAGENTS ARE VALIDATED, PEPFAR APPROVED, WHO PREQUALIFIED, AND FDA APPROVED FOR HIV VIRAL LOAD AND EARLY INFANT DIAGNOSIS EID TESTING AND MEETS THE REQUIREMENTS NEEDED TO PERFORM HIV VIRA Key points: 1. The contract focuses on critical HIV viral load and early infant diagnosis testing, aligning with global health priorities. 2. Roche Diagnostics Corporation is the sole provider for these specific validated and approved systems. 3. The contract value is substantial, indicating significant investment in HIV testing infrastructure. 4. The primary risk lies in the reliance on a single supplier for these essential diagnostic tools.

Value Assessment

Rating: good

The contract value of $130,151.3 is for a single delivery order for analytical laboratory instruments and associated reagents. Benchmarking is difficult without specific unit pricing, but the overall award appears reasonable for specialized, validated diagnostic equipment.

Cost Per Unit: N/A

Competition Analysis

Competition Level: limited

The contract was awarded under full and open competition, but the specific systems (Cobas R 4800 and 6800) and associated reagents likely limit the practical competition to Roche Diagnostics Corporation. This could impact price discovery if alternative systems are not considered.

Taxpayer Impact: Taxpayers are funding essential public health infrastructure for HIV testing, which is a critical component of disease control and prevention efforts.

Public Impact

Ensures continued access to vital HIV viral load and early infant diagnosis testing. Supports global health initiatives like PEPFAR through the provision of WHO prequalified technology. Maintains the operational capacity of analytical laboratories for critical diagnostic services. Potential for supply chain disruptions if issues arise with the sole-source provider.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Sole-source reliance for critical diagnostics
Potential for price increases without competitive pressure

Positive Signals

Validated, PEPFAR approved, and WHO prequalified technology
Supports critical public health mission

Sector Analysis

The healthcare sector, specifically medical diagnostics, is characterized by high R&D costs and stringent regulatory approvals. Spending in this area is often driven by public health needs and the necessity of validated, reliable equipment.

Small Business Impact

This contract does not appear to directly involve small businesses, as it is awarded to a large corporation (Roche Diagnostics Corporation) for specialized equipment and reagents.

Oversight & Accountability

The award falls under the Centers for Disease Control and Prevention (CDC), a key agency within HHS. Oversight would involve monitoring contract performance, delivery schedules, and ensuring the continued availability and quality of the reagents and systems.

Related Government Programs

Analytical Laboratory Instrument Manufacturing
Department of Health and Human Services Contracting
Centers for Disease Control and Prevention Programs

Risk Flags

Sole-source reliance
Potential for price increases
Supply chain vulnerability
Dependence on specific technology

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $130,151.3 to ROCHE DIAGNOSTICS CORPORATION. THE ROCHE COBAS R 4800 AND COBAS R 6800 SYSTEMS AND ASSOCIATED REAGENTS ARE VALIDATED, PEPFAR APPROVED, WHO PREQUALIFIED, AND FDA APPROVED FOR HIV VIRAL LOAD AND EARLY INFANT DIAGNOSIS EID TESTING AND MEETS THE REQUIREMENTS NEEDED TO PERFORM HIV VIRA

Who is the contractor on this award?

The obligated recipient is ROCHE DIAGNOSTICS CORPORATION.

Which agency awarded this contract?

Awarding agency: Department of Health and Human Services (Centers for Disease Control and Prevention).

What is the total obligated amount?

The obligated amount is $130,151.3.

What is the period of performance?

Start: 2024-08-21. End: 2025-08-01.

What is the long-term strategy for ensuring competitive pricing for these essential diagnostic systems and reagents, given the current limited competition?

The long-term strategy should explore opportunities for market research into alternative validated systems or components that could foster future competition. Periodic reviews of the sole-source justification and potential for developing or acquiring comparable technologies by other manufacturers should be considered to mitigate long-term price escalation and ensure supply chain resilience.

How is the risk of supply chain disruption managed when relying on a single manufacturer for critical HIV diagnostic tools?

Risk mitigation involves maintaining strong communication channels with Roche Diagnostics, monitoring their production capacity and inventory levels, and potentially establishing strategic stockpiles of critical reagents. Contingency planning should also include identifying potential alternative testing methods or suppliers, even if they require re-validation, to ensure continuity of essential services.

What is the process for evaluating the effectiveness and ongoing suitability of the Roche Cobas R systems and reagents for evolving HIV testing needs?

Effectiveness is evaluated through ongoing performance monitoring, quality control data from the laboratories utilizing the systems, and adherence to updated testing guidelines from organizations like the WHO. Regular reviews with the vendor will assess system updates, reagent efficacy, and alignment with emerging public health requirements for HIV diagnostics.

Industry Classification

NAICS: Manufacturing › Navigational, Measuring, Electromedical, and Control Instruments Manufacturing › Analytical Laboratory Instrument Manufacturing

Product/Service Code: INSTRUMENTS AND LABORATORY EQPT

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION

Solicitation Procedures: SUBJECT TO MULTIPLE AWARD FAIR OPPORTUNITY

Solicitation ID: 2024-EJH-00249

Offers Received: 1

Pricing Type: FIRM FIXED PRICE (J)

Evaluated Preference: NONE

Contractor Details

Parent Company: Roche Holding AG

Address: 9115 HAGUE RD, INDIANAPOLIS, IN, 46256

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

Financial Breakdown

Contract Ceiling: $130,151

Exercised Options: $130,151

Current Obligation: $130,151

Actual Outlays: $67,501

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES

Cost or Pricing Data: NO

Parent Contract

Parent Award PIID: V797D70105

IDV Type: FSS

Timeline