HHS Awards $2.48M for Point-of-Care White Blood Cell Analysis Platform

Contract Overview

Contract Amount: $2,483,472 ($2.5M)

Contractor: Rizlab Health Inc

Awarding Agency: Department of Health and Human Services

Start Date: 2023-08-11

End Date: 2027-04-10

Contract Duration: 1,338 days

Daily Burn Rate: $1.9K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 1

Pricing Type: FIRM FIXED PRICE

Sector: R&D

Official Description: RESEARCH AND DEVELOPMENT- AOI #16+ SEEKING TO MANUFACTURE AND OBTAIN REGULATORY APPROVAL FOR THE CYTOTRACKER BV, A POINT-OF-CARE INSTANT WHITE BLOOD CELL ANALYSIS PLATFORM FOR DISCRIMINATING BETWEEN ACUTE VIRAL AND BACTERIAL INFECTIONS.

Place of Performance

Location: PRINCETON, MERCER County, NEW JERSEY, 08540

State: New Jersey Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $2.5 million to RIZLAB HEALTH INC for work described as: RESEARCH AND DEVELOPMENT- AOI #16+ SEEKING TO MANUFACTURE AND OBTAIN REGULATORY APPROVAL FOR THE CYTOTRACKER BV, A POINT-OF-CARE INSTANT WHITE BLOOD CELL ANALYSIS PLATFORM FOR DISCRIMINATING BETWEEN ACUTE VIRAL AND BACTERIAL INFECTIONS. Key points: 1. Focuses on a novel point-of-care diagnostic platform for infection discrimination. 2. Competition was full and open, suggesting a competitive bidding process. 3. The contract is firm-fixed-price, which transfers cost risk to the contractor. 4. This falls under R&D in Biotechnology, a critical area for public health preparedness.

Value Assessment

Rating: good

The contract value of $2.48M for a definitive contract with a 4-year duration appears reasonable for R&D in biotechnology. Benchmarking against similar R&D contracts would provide further context.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

Full and open competition was utilized, indicating that multiple vendors had the opportunity to bid. This method generally promotes price discovery and competitive pricing.

Taxpayer Impact: The investment aims to improve diagnostic capabilities, potentially leading to more efficient treatment and reduced healthcare costs for the public.

Public Impact

Potential to improve rapid diagnosis of infections at the point-of-care. Could reduce reliance on centralized labs, speeding up treatment decisions. Aims to differentiate between viral and bacterial infections, guiding appropriate antibiotic use.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

  • Regulatory approval timeline uncertainty.
  • Market adoption challenges for new diagnostic platforms.

Positive Signals

  • Addresses a critical public health need for rapid diagnostics.
  • Utilizes a firm-fixed-price contract to control costs.
  • Full and open competition was pursued.

Sector Analysis

This contract falls within the Research and Development in Biotechnology sector, specifically focusing on developing a novel diagnostic platform. Spending in this area is crucial for advancing medical technology and public health preparedness, with significant government investment often seen in areas with high potential impact.

Small Business Impact

The data indicates the awardee is RIZLAB HEALTH INC. Further analysis would be needed to determine if this is a small business and if subcontracting opportunities for small businesses are included in the contract.

Oversight & Accountability

The Department of Health and Human Services, specifically the Office of Assistant Secretary for Preparedness and Response, is overseeing this contract. Standard oversight mechanisms for R&D contracts would apply, focusing on milestones and deliverables.

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

  • Potential for R&D delays impacting timeline.
  • Uncertainty in achieving regulatory approval.
  • Market adoption challenges for a new diagnostic technology.
  • Dependence on specific scientific breakthroughs.

Tags

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

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $2.5 million to RIZLAB HEALTH INC. RESEARCH AND DEVELOPMENT- AOI #16+ SEEKING TO MANUFACTURE AND OBTAIN REGULATORY APPROVAL FOR THE CYTOTRACKER BV, A POINT-OF-CARE INSTANT WHITE BLOOD CELL ANALYSIS PLATFORM FOR DISCRIMINATING BETWEEN ACUTE VIRAL AND BACTERIAL INFECTIONS.

Who is the contractor on this award?

The obligated recipient is RIZLAB HEALTH 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 $2.5 million.

What is the period of performance?

Start: 2023-08-11. End: 2027-04-10.

What is the projected timeline for achieving regulatory approval for the Cytotracker BV platform?

The contract end date is April 10, 2027, suggesting that regulatory approval is anticipated within this timeframe. However, the specific milestones for regulatory submission and approval are not detailed in the provided data. This timeline is subject to the complexities of the regulatory process and the success of the R&D efforts.

What are the key performance indicators (KPIs) for this R&D contract to ensure effectiveness?

Key performance indicators would likely include successful development of a functional prototype, achievement of specified diagnostic accuracy benchmarks (sensitivity and specificity), successful completion of validation studies, and timely submission of documentation for regulatory review. The firm-fixed-price nature incentivizes the contractor to meet these technical and regulatory milestones efficiently.

How does the $2.48M contract value compare to similar R&D efforts in point-of-care diagnostics?

Without specific benchmarks for comparable point-of-care diagnostic R&D contracts, it's difficult to definitively assess value. However, the amount seems reasonable for developing a novel platform requiring significant research, prototyping, and clinical validation, especially considering the potential for regulatory hurdles and the firm-fixed-price structure which may include contingency.

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: BASIC RESEARCH

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

Offers Received: 1

Pricing Type: FIRM FIXED PRICE (J)

Evaluated Preference: NONE

Contractor Details

Address: 303A COLLEGE RD E, PRINCETON, NJ, 08540

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

Financial Breakdown

Contract Ceiling: $2,483,472

Exercised Options: $2,483,472

Current Obligation: $2,483,472

Actual Outlays: $1,051,247

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: NO

Timeline

Start Date: 2023-08-11

Current End Date: 2027-04-10

Potential End Date: 2027-04-10 00:00:00

Last Modified: 2026-02-09

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