SSJF Part 1 BioFire Global Fever SS 58500022M APO Signature_.pdf
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- Solicitation number
- 25-482DPH-OFCDI-B-46845
- Issued by
- Illinois
About this file
This is a Sole Source Justification Form from the Illinois Department of Public Health (IDPH), involving BioFire Defense, LLC for the procurement of diagnostic testing equipment and services. The project, titled "Sole Source BioFire IDPH Labs Testing and Warranty," involves purchasing BioFire FilmArray 2.0 Global Fever Pathogen Panel reagents, consumables, and warranty coverage. The contract includes 50 Global Fever Special Pathogens Panels, 10 BIOFIRE SHIELD Control Kits, 10 Gastrointestinal Panels, shipping, and a one-year extended warranty for six instruments. The contract term is from May 1, 2025, to April 30, 2026, with a total value of $154,478.
The funding for this procurement will come from state and federal funds, specifically to support public health laboratory operations for detecting infectious diseases like Ebola, malaria, dengue, and Zika. The sole source justification is based on the BioFire system being the only FDA Emergency Use Authorization (EUA) approved system for Laboratory Response Network (LRN) Ebola virus detection, with exclusive authorization from the CDC and Department of Defense. The pricing was determined through comparison with previous contracts and industry standards, and the procurement aims to maintain IDPH's critical diagnostic capabilities, LRN certification, and federal funding eligibility while avoiding the significant costs of replacing existing infrastructure.
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Sole Source Justification Form
Version 7.01 Page 1 of 7
Bulletin Reference Number 25-482DPH-OFCDI-B-46845
Requesting Agency/University Illinois Department of Public Health (IDPH)
Sole Source Justification Form - Part I Section I - General Information
Department/Bureau/Section: Office of Disease Control (ODC) / Division of Laboratories
Need Identified Date: Dec 17, 2024 Supply/Service Need By Date: May 1, 2025
Project Title: Sole Source BioFire IDPH Labs Testing and Warranty
Vendor: BioFire Defense, LLC
Provide a description of the supplies or services required:
The procurement is for BioFire Defense LLC (BioFire) test kits, reagents, and associated consumables required for rapid molecular diagnostic testing.
Additionally, the purchase includes software, maintenance, and technical support services necessary for the operation and upkeep of BioFire systems already owned by IDPH.
Value: Actual Value of Initial Term, this Change Order or Amendment: 154,478
Will this Sole Source amend a Professional or Artistic Services contract? Yes No
*Sole Source may not be used for amendments for Professional or Artistic Services if the amendment would increase the value by more than 5% of the initial award or extend the term by more than 60 days.
Type: New Sole Source
Section II - Proposed Term
One-Time Purchase Term Contract
Estimated Contract Begin Date: May 1, 2025
Estimated Contract End Date: Apr 30, 2026
Number of Potential Renewals:
Length of Each Renewal in Months:
Total Value of All Renewals:
If a Term Contract, does the term, including renewals, exceed 12 months? Yes No
Section III - Funding Source Select the type of funding to be used (Check all that apply): State Appropriate Funds Federal Funds Other (Explain):
Section IV - Sole Source Justification
This purchase is economically only available from a single source primarily because it is: (If "Other" explain in one sentence)
Compatibility of Equipment, Accessories, Replacement Parts or Service
Are there secondary justification(s) for this sole source? Yes No
Version 7.01 Page 2 of 7
Bulletin Reference Number 25-482DPH-OFCDI-B-46845
Requesting Agency/University Illinois Department of Public Health (IDPH)
Section V - Purchase History
Has the Agency or University Purchased these supplies or services in the past? Yes No
Term Term From Term To Value Description Contract Number Type
1 05/01/2024 04/30/2025 88,466 BioFire Defense, LLC Reagent and Extended Warranty Small Purchase with Sole Source Conditions
485000028L Small Purchase
2 05012023 04/30/2024 98,948 BioFire Reagent SP W SS conditions 38500025K Small Purchase
If more than 10, or if other comments, explain:
Section VI - Business Rationale
1. Provide a detailed explanation of the need for the supplies or services:
The Illinois Department of Public Health (IDPH) requires BioFire Defense, LLC BIOFIRE® FILMARRAY® 2.0 Global Fever Pathogen Panel and associated reagents, consumables, and warranty coverage to support public health laboratory operations. These diagnostic tools are essential for detecting infectious diseases, including Ebola, malaria, dengue, Zika, and various gastrointestinal pathogens. IDPH’s mission is to protect public health and respond swiftly to outbreaks, and these supplies directly enable timely disease identification and containment.
2. Provide a list and describe in detail the specifications required to satisfy the need:
The procurement includes the following BioFire items, specifically designed for use with IDPH's existing BioFire FilmArray 2.0 instruments:
Item Description / Item Number / Quantity /
• Global Fever Special Pathogens Panel IVD (6 Tests) / DFA2-ASY-0018 / 50 /
• BIOFIRE SHIELD Control Kit for Global Fever Special Pathogens Panel (12 Controls) / DFA2-ASY-0019 / 10
• Gastrointestinal Panel IVD (30 Tests) / RFIT-ASY-0116 / 10 /
• Shipping / 25 /
• FilmArray 2.0 Extended Warranty (1 year coverage for 6 instruments) / FLM1-PRT-0018 / 6
These items will be shipped in up to 25 deliveries to the IDPH Chicago and Springfield labs.
Version 7.01 Page 3 of 7
Bulletin Reference Number 25-482DPH-OFCDI-B-46845
Requesting Agency/University Illinois Department of Public Health (IDPH)
3. Provide detail explaining the justification selected in Section IV to explain why the requested supplies or services are the only ones available that can satisfy the agency or university requirements?
The requested BioFire Global Fever and Gastrointestinal Panels are the only diagnostic reagents compatible with IDPH's existing BioFire FilmArray 2.0 instruments. The CDC and DoD exclusively authorize BioFire FilmArray for Ebola virus detection, and no other reagents have been validated for use with these systems.
IDPH has invested $389,189.42 in BioFire FilmArray 2.0 instruments and consumable supplies to align with CDC-recommended guidelines. Six existing BioFire FilmArray 2.0 instruments are in use in laboratories across Illinois. IDPH's investment has allowed it to maintain its LRN certification and receive funding from the CDC, which allows LRN labs across the United States to have comparable results for trend analyses.
Since BioFire Global Fever and Gastrointestinal Panels are not available for retail sale, BioFire Defense, LLC is the only source for the required reagents and extended warranty. This would allow IDPH to maintain its certification and not reinvest in a new system that would not meet the same requirements.
Key reasons:
• CDC and DoD approval for pathogen detection, including Ebola.
• LRN compliance: IDPH labs must use CDC-approved methods for disease surveillance.
• No alternative reagents exist that are compatible with FilmArray 2.0.
• System-wide integration: Switching platforms would require replacing all instruments and retraining staff, incurring excessive costs and delays.
• Warranty coverage is only provided by BioFire Defense, LLC.
The BioFire FilmArray System is the only system approved by the Center for Disease Control (CDC) and the Department of Defense (DoD) for Ebola detection within the Laboratory Response Network (LRN). The Laboratory Response Network (LRN) is a network of domestic and international laboratories established to respond to biological and chemical threats, and emerging infectious diseases. In 1999, the Centers for Disease Control and Prevention (CDC) established the Laboratory Response Network (LRN). IDPH labs are part of this network and in order to remain need to align IDPH's operations with the CDC guidlines.
DoD & CDC LRN Deployment of BioFire FilmArrayThese sources confirm that BioFire FilmArray is approved for use within the LRN, and as no similar publications exist for other Ebola testing systems, it remains the only system with documented approval.
• FDA Emergency Use Authorization (EUA) for the BioFire FilmArray Ebola Test: https://www.fda.gov/media/89580/download and https://www.fda.gov/media/89585/download
• FDA EUA for BioFire FilmArray Department of Defense (DoD) Collaboration with BioFire Defense for Ebola Detection: https:// www.jpeocbrnd.osd.mil/Media/News/Article/2495695/increased-collaboration-promotes-improved-medical-diagnostic-capabilities-and-h/
The system also plays a crucial role in testing for gastrointestinal pathogens and febrile illnesses, ensuring faster treatment, reducing hospitalization time, and limiting disease spread in the community.
Without these supplies, IDPH would lack critical diagnostic capabilities necessary for:• Outbreak response and containment (Ebola, malaria, foodborne illnesses).
• Rapid pathogen detection (reducing turnaround times to ~1 hour).
• Ensuring biosafety compliance (avoiding testing bottlenecks due to BSL-2/BSL-3 limitations).
• Maintaining operational efficiency (ensuring IDPH labs are equipped with necessary reagents and warranty coverage to prevent downtime).
Version 7.01 Page 4 of 7
Bulletin Reference Number 25-482DPH-OFCDI-B-46845
Requesting Agency/University Illinois Department of Public Health (IDPH)
4. What are the unique features of the supplies or services that are not available in any other product or by any other vendor? Provide specific quantifiable factors/qualifications:
BioFire FilmArray is the only one with publicly available documentation confirming its approval for use within the LRN. No published sources explicitly state that the other systems are not LRN-approved; instead, there is an absence of documentation from the CDC confirming their approval.
• Only FDA EUA-approved system for LRN-based Ebola virus detection.
• Only system integrating Global Fever Panel pathogens in a single test workflow.
• Fully automated, closed-cartridge system to reduce contamination risk.
• Regulatory compliance with CDC and IDPH biosafety requirements (BSL-3 testing for Ebola, BSL-2 screening for malaria and other pathogens)
.• Provided solely with maintenance, software, and extended warranties, ensuring operational readiness.
5. Has the Agency or University considered alternative supplies or services to satisfy their need? Yes No
5a. If yes, name the alternative vendors whose supplies or services were evaluated:
Alternative systems were considered but found unsuitable due to lack of CDC/DoD approval, incompatibility with IDPH's existing infrastructure, and failure to meet biosafety and regulatory requirements. Alternative vendors considered: Cepheid, altona Diagnostics, and OraSure Technologies.
5b. If yes, what were the alternatives for each vendor and why were they unacceptable? Be specific with regard to features, characteristics, requirements, capabilities and compatibility:
IDPH researched all providers of Ebola testing reagents through publicly available information on the Internet and through network connections at other laboratories and found none were compatible with IDPH's existing systems.
• Cepheid: GeneXpert Ebola Assay: Not authorized for LRN laboratory confirmatory testing; cartridge-based but lacks Global Fever Panel capabilities.
• Altona: Diagnostics RealStar Ebolavirus RT-PCR: Requires open-platform PCR instruments, longer turnaround time (3-4 hours), lacks full automation, and does not integrate with BioFire instruments.
• OraSure Technologies: OraQuick Rapid Ebola Antigen Test: This is only an antigen-based screening test, not a PCR confirmatory test, making it unsuitable for IDPH lab needs.
5c. Explain how the market evaluation was conducted?
*This evaluation is to determine available options within a market. If the evaluation is to determine quality or best suited option, this is not the appropriate source selection. Under no circumstances shall the evaluation consist of testing alternative options. These activities must be conducted in a competitive transparent environment (i.e. IFB or RFP).
• CDC Laboratory Response Network (LRN) guidelines, which specify BioFire as the only authorized system for LRN-based Ebola testing.
• Industry research by Dr. Joshua Geltz, Division Chief, confirming that no other reagents can be used on BioFire FilmArray 2.0 for Global Fever Panel pathogens. reseach was done through publicly available information on the Internet and through network connections at other laboratories
• Cost analysis, verifying that BioFire reagent pricing aligns with industry standards.
6. Are there resellers or distributors?
Yes No N/A
Version 7.01 Page 5 of 7
Bulletin Reference Number 25-482DPH-OFCDI-B-46845
Requesting Agency/University Illinois Department of Public Health (IDPH)
7. What efforts were made to get the best possible price (i.e. did the agency/university negotiate) and how did you determine the price for this purchase is considered fair and reasonable?
• Comparison with previous BioFire reagent contracts and publicly available pricing of alternative reagents confirmed that pricing remains consistent with industry standards.
Item Description / Item Number / Quantity / Unit Cost / Total Cost
• Global Fever Special Pathogens Panel IVD (6 Tests) / DFA2-ASY-0018 / 50 / $1,453.00 / $72,650.00
• BIOFIRE SHIELD Control Kit for Global Fever Special Pathogens Panel (12 Controls) / DFA2-ASY-0019 / 10 $387.00 / $3,870.00
• Gastrointestinal Panel IVD (30 Tests) / RFIT-ASY-0116 / 10 / $4,933.00 / $49,330.00
• Shipping / 25 / $20.00 / $500.00
• FilmArray 2.0 Extended Warranty (1 year coverage for 6 instruments) / FLM1-PRT-0018 / 6 $4,688.00 / $28,128.00
• Total Contract Cost: $154,478.00
8. Will this purchase obligate the State to this vendor for future purchases such as maintenance, licensing or continuing need?
Yes No
9. What will be the financial or other impact to the State if this sole source is not approved and a competitive bid is required?
The total contract cost of $154,478.00 is justified by:
• Avoiding downtime: Ensures continued public health emergency response.
• Preventing outbreaks: Timely detection of Ebola, malaria, and gastrointestinal illnesses prevents larger public health crises.
• Maintaining LRN compliance: IDPH labs must follow CDC testing protocols.
• Delays in Testing: IDPH labs would be unable to perform rapid, CDC-compliant testing for Ebola and other high-risk pathogens, jeopardizing outbreak response capabilities.
• Regulatory & LRN Compliance Risks: IDPH could risk losing its LRN status, which requires CDC-approved testing methodologies.
• Hospital Reluctance to Test: As seen during the Fall 2022 Ebola outbreak, hospitals were unwilling to test for malaria and other fever pathogens in suspected Ebola patients due to biosafety restrictions. The BioFire system allows all testing to occur in a BSL-3 environment, resolving this issue.
• Disruption of Existing Testing Infrastructure: BioFire FilmArray 2.0 instruments are already owned and fully operational at IDPH labs.
Switching to a different system would cause unnecessary disruptions, additional costs, and prolonged training times.
• Loss of Federal Funding & Public Health Readiness: The inability to conduct CDC-compliant testing could affect IDPH’s eligibility for federal funding related to infectious disease preparedness.
• Not having to repurchase new equipment to utilize an alternative reagent. will save the State of Illinois from having to re-invest $389,189.42 in a completely new systems.
10. Is there any additional information you would like to add to justify this sole source?
Version 7.01 Page 6 of 7
Bulletin Reference Number 25-482DPH-OFCDI-B-46845
Requesting Agency/University Illinois Department of Public Health (IDPH)
Section VII
Requesting Department Representative
Requesting Department Signature Required
I know and understand the contents of this Sole Source Justification and attest that all statements are true and correct and the fairness and reasonableness of the price was adequately confirmed.
Date Mar 6, 2025
Printed Name Leslie A Chapman E-mail Address Leslie.chapman@illinois.gov
Phone Number 618-457-5131
State Agency Bureau/Division Head or University Purchasing Director Approval and Signature Required
I know and understand the contents of this Sole Source Justification and attest that all statements are true and correct and the fairness and reasonableness of the price was adequately confirmed. (All prior form fields will lock once this e-signature is completed)
E-mail Address Mike.Caceres@illinois.gov
Phone Number 217-557-7905 Date Mar 6, 2025
Printed Name Mike Caceres
Agency Bureau/Division Head or University Purchasing Director and Not a Designee
SPO Approval and Signature Required
I have reviewed and understand the contents of this Sole Source Justification and agree with the State Agency or University determination.
I have reviewed and understand the contents of this Sole Source Justification and do not agree with the State Agency or University determination. As a result, the State Agency or University must explore other sourcing methods to satisfy their need.
State Purchasing Officer Signature Phone Number 217-299-5883 Date 03/06/2025
Printed Name Rebecca Gossett E-mail Address rebecca.gossett@illinois.gov
Version 7.01 Page 7 of 7
Bulletin Reference Number 25-482DPH-OFCDI-B-46845
Requesting Agency/University Illinois Department of Public Health (IDPH)
Sole Source Justification Form - Part II Section I - General Information
Project Title Sole Source BioFire IDPH Labs Testing and Warranty
Vendor BioFire Defense, LLC
Initial Date of Procurement Bulletin Posting
Was a Sole Source hearing held per 30 ILCS 500/20-25?
Yes - Complete Section II and III below (Section II will only be visible when this option is selected)
No - Section II not required, go to Section III below Section III - CPO Approval and Signature Required
Based on my review, I authorize the Agency/University to proceed in accordance with the published Notice referenced above.
Based upon my review, I authorize the Agency/University to proceed with the following Changes.
Based on my review, the Agency/University is not authorized to proceed with this sole source as presented and my recommendation is that it be cancelled.
Other
CPO Signature CPO Phone 217-558-2231
Printed Name Ellen H. Daley Date
CPO E-mail Ellen.H.Daley@illinois.gov
Version 7.01 Page of Sole Source Justification Form - Part I Section I - General Information Will this Sole Source amend a Professional or Artistic Services contract?
If yes, what was the original contract value?
*Sole Source may not be used for amendments for Professional or Artistic Services if the amendment would increase the value by more than 5% of the initial award or extend the term by more than 60 days.
Section II - Proposed Term If a Term Contract, does the term, including renewals, exceed 12 months?
If yes, provide a detailed justification including any economic benefit received for agreeing to a multi-year term:
Section III - Funding Source Select the type of funding to be used (Check all that apply):
Section IV - Sole Source Justification Are there secondary justification(s) for this sole source?
Section V - Purchase History Has the Agency or University Purchased these supplies or services in the past?
Term Term From Term To Value Description Contract Number Type Section VI - Business Rationale
1. Provide a detailed explanation of the need for the supplies or services:
2. Provide a list and describe in detail the specifications required to satisfy the need:
3. Provide detail explaining the justification selected in Section IV to explain why the requested supplies or services are the only ones available that can satisfy the agency or university requirements?
4. What are the unique features of the supplies or services that are not available in any other product or by any other vendor? Provide specific quantifiable factors/qualifications:
5. Has the Agency or University considered alternative supplies or services to satisfy their need?
5a. If yes, name the alternative vendors whose supplies or services were evaluated:
5b. If yes, what were the alternatives for each vendor and why were they unacceptable? Be specific with regard to features, characteristics, requirements, capabilities and compatibility:
5c. Explain how the market evaluation was conducted?
*This evaluation is to determine available options within a market. If the evaluation is to determine quality or best suited option, this is not the appropriate source selection. Under no circumstances shall the evaluation consist of testing alternative options. These activities must be conducted in a competitive transparent environment (i.e. IFB or RFP).
5a. If no, why weren't alternatives evaluated?
6. Are there resellers or distributors?
7. What efforts were made to get the best possible price (i.e. did the agency/university negotiate) and how did you determine the price for this purchase is considered fair and reasonable?
8. Will this purchase obligate the State to this vendor for future purchases such as maintenance, licensing or continuing need?
8a. If yes, please provide details regarding future obligations and/or needs:
9. What will be the financial or other impact to the State if this sole source is not approved and a competitive bid is required?
10. Is there any additional information you would like to add to justify this sole source?
Section VII Requesting Department Signature Required I know and understand the contents of this Sole Source Justification and attest that all statements are true and correct and the fairness and reasonableness of the price was adequately confirmed.
State Agency Bureau/Division Head or University Purchasing Director Approval and Signature Required I know and understand the contents of this Sole Source Justification and attest that all statements are true and correct and the fairness and reasonableness of the price was adequately confirmed. (All prior form fields will lock once this e-signature is completed) SPO Approval and Signature Required Sole Source Justification Form - Part II Section I - General Information Was a Sole Source hearing held per 30 ILCS 500/20-25?
Section II - Sole Source Hearing Details The State posted to the Illinois Procurement Bulletin a description of the State's need, the justification for the sole source decision, and information regarding the opportunity to submit comments and testify at a public hearing. Notice of the hearing was also posted outside of the hearing room 48 hours prior to the hearing.
The public hearing was conducted for the purpose of receiving testimony regarding the sole source determination. The Hearing Officer recommends the following:
The following relevant documents are attached:
Section III - CPO Approval and Signature Required 9.0.0.2.20101008.1.734229 Ellen.H.Daley@illinois.gov
| BulletinNum: 25-482DPH-OFCDI-B-46845 |
| Requesting: Illinois Department of Public Health (IDPH) |
| CurrentPage: |
| PageCount: |
| Department: Office of Disease Control (ODC) / Division of Laboratories |
| NeedIdentifiedDate: 2024-12-17 |
| NeedbyDate: 2025-05-01 |
| ProjectTitle: Sole Source BioFire IDPH Labs Testing and Warranty |
| ProjectTitle: Sole Source BioFire IDPH Labs Testing and Warranty |
| Vendor: BioFire Defense, LLC |
| Vendor: BioFire Defense, LLC |
| Description: The procurement is for BioFire Defense LLC (BioFire) test kits, reagents, and associated consumables required for rapid molecular diagnostic testing. Additionally, the purchase includes software, maintenance, and technical support services necessary for the operation and upkeep of BioFire systems already owned by IDPH. |
| ValueIs: Actual |
| ValueofInitialTerm: 154478.00000000 |
| P-Ayes: |
| P-Ano: |
| P-AValue: |
| ThisIsA: New Sole Source |
| One-Time: |
| Term: |
| BeginDate: 2025-05-01 |
| EndDate: 2026-04-30 |
| NumberofRenewals: |
| RenewalLength: |
| RenewalValue: |
| ExceedingYes: |
| ExceedingNo: |
| TextField3: |
| StateFunds: 1 |
| FederalFunds: 1 |
| FundingOther: 0 |
| TextField4: BioFire Defense, LLC Reagent and Extended Warranty Small Purchase with Sole Source Conditions |
| DropDownList1: Compatibility of Equipment, Accessories, Replacement Parts or Service |
| DropDownList1: Small Purchase |
| DropDownList1: Small Purchase |
| Justify: |
| PastYes: |
| PastNo: |
| DateTimeField20: 05/01/2024 |
| DateTimeField19: 04/30/2025 |
| NumericField8: 88466.00000000 |
| TextField5: 485000028L |
| DateTimeField18: 05012023 |
| DateTimeField17: 04/30/2024 |
| NumericField9: 98948.00000000 |
| TextField10: BioFire Reagent SP W SS conditions |
| TextField11: 38500025K |
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| DateTimeField4: 2025-03-06 |
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| Q1Answer: The Illinois Department of Public Health (IDPH) requires BioFire Defense, LLC BIOFIRE® FILMARRAY® 2.0 Global Fever Pathogen Panel and associated reagents, consumables, and warranty coverage to support public health laboratory operations. These diagnostic tools are essential for detecting infectious diseases, including Ebola, malaria, dengue, Zika, and various gastrointestinal pathogens. IDPH’s mission is to protect public health and respond swiftly to outbreaks, and these supplies directly enable timely disease identification and containment. |
Q2Answer: The procurement includes the following BioFire items, specifically designed for use with IDPH's existing BioFire FilmArray 2.0 instruments:
Item Description / Item Number / Quantity /
• Global Fever Special Pathogens Panel IVD (6 Tests) / DFA2-ASY-0018 / 50 /
• BIOFIRE SHIELD Control Kit for Global Fever Special Pathogens Panel (12 Controls) / DFA2-ASY-0019 / 10
• Gastrointestinal Panel IVD (30 Tests) / RFIT-ASY-0116 / 10 /
• Shipping / 25 /
• FilmArray 2.0 Extended Warranty (1 year coverage for 6 instruments) / FLM1-PRT-0018 / 6
Q3Answer: The requested BioFire Global Fever and Gastrointestinal Panels are the only diagnostic reagents compatible with IDPH's existing BioFire FilmArray 2.0 instruments. The CDC and DoD exclusively authorize BioFire FilmArray for Ebola virus detection, and no other reagents have been validated for use with these systems.
IDPH has invested $389,189.42 in BioFire FilmArray 2.0 instruments and consumable supplies to align with CDC-recommended guidelines. Six existing BioFire FilmArray 2.0 instruments are in use in laboratories across Illinois. IDPH's investment has allowed it to maintain its LRN certification and receive funding from the CDC, which allows LRN labs across the United States to have comparable results for trend analyses.
Since BioFire Global Fever and Gastrointestinal Panels are not available for retail sale, BioFire Defense, LLC is the only source for the required reagents and extended warranty. This would allow IDPH to maintain its certification and not reinvest in a new system that would not meet the same requirements.
Key reasons:
• CDC and DoD approval for pathogen detection, including Ebola.
• LRN compliance: IDPH labs must use CDC-approved methods for disease surveillance.
• No alternative reagents exist that are compatible with FilmArray 2.0.
• System-wide integration: Switching platforms would require replacing all instruments and retraining staff, incurring excessive costs and delays.
• Warranty coverage is only provided by BioFire Defense, LLC.
The BioFire FilmArray System is the only system approved by the Center for Disease Control (CDC) and the Department of Defense (DoD) for Ebola detection within the Laboratory Response Network (LRN). The Laboratory Response Network (LRN) is a network of domestic and international laboratories established to respond to biological and chemical threats, and emerging infectious diseases. In 1999, the Centers for Disease Control and Prevention (CDC) established the Laboratory Response Network (LRN). IDPH labs are part of this network and in order to remain need to align IDPH's operations with the CDC guidlines.
DoD & CDC LRN Deployment of BioFire FilmArrayThese sources confirm that BioFire FilmArray is approved for use within the LRN, and as no similar publications exist for other Ebola testing systems, it remains the only system with documented approval.
• FDA Emergency Use Authorization (EUA) for the BioFire FilmArray Ebola Test: https://www.fda.gov/media/89580/download and https://www.fda.gov/media/89585/download
• FDA EUA for BioFire FilmArray Department of Defense (DoD) Collaboration with BioFire Defense for Ebola Detection: https://www.jpeocbrnd.osd.mil/Media/News/Article/2495695/increased-collaboration-promotes-improved-medical-diagnostic-capabilities-and-h/
The system also plays a crucial role in testing for gastrointestinal pathogens and febrile illnesses, ensuring faster treatment, reducing hospitalization time, and limiting disease spread in the community.
Without these supplies, IDPH would lack critical diagnostic capabilities necessary for:• Outbreak response and containment (Ebola, malaria, foodborne illnesses).
• Rapid pathogen detection (reducing turnaround times to ~1 hour).
• Ensuring biosafety compliance (avoiding testing bottlenecks due to BSL-2/BSL-3 limitations).
• Maintaining operational efficiency (ensuring IDPH labs are equipped with necessary reagents and warranty coverage to prevent downtime).
Q4Answer: BioFire FilmArray is the only one with publicly available documentation confirming its approval for use within the LRN. No published sources explicitly state that the other systems are not LRN-approved; instead, there is an absence of documentation from the CDC confirming their approval.
• Only FDA EUA-approved system for LRN-based Ebola virus detection.
• Only system integrating Global Fever Panel pathogens in a single test workflow.
• Fully automated, closed-cartridge system to reduce contamination risk.
• Regulatory compliance with CDC and IDPH biosafety requirements (BSL-3 testing for Ebola, BSL-2 screening for malaria and other pathogens)
.• Provided solely with maintenance, software, and extended warranties, ensuring operational readiness.
| altYes: |
| altNo: |
| Q5aAnswer: Alternative systems were considered but found unsuitable due to lack of CDC/DoD approval, incompatibility with IDPH's existing infrastructure, and failure to meet biosafety and regulatory requirements. Alternative vendors considered: Cepheid, altona Diagnostics, and OraSure Technologies. |
| Q5bAnswer: IDPH researched all providers of Ebola testing reagents through publicly available information on the Internet and through network connections at other laboratories and found none were compatible with IDPH's existing systems. |
• Cepheid: GeneXpert Ebola Assay: Not authorized for LRN laboratory confirmatory testing; cartridge-based but lacks Global Fever Panel capabilities.
• Altona: Diagnostics RealStar Ebolavirus RT-PCR: Requires open-platform PCR instruments, longer turnaround time (3-4 hours), lacks full automation, and does not integrate with BioFire instruments.
• OraSure Technologies: OraQuick Rapid Ebola Antigen Test: This is only an antigen-based screening test, not a PCR confirmatory test, making it unsuitable for IDPH lab needs.
Q5cAnswer: • CDC Laboratory Response Network (LRN) guidelines, which specify BioFire as the only authorized system for LRN-based Ebola testing.
• Industry research by Dr. Joshua Geltz, Division Chief, confirming that no other reagents can be used on BioFire FilmArray 2.0 for Global Fever Panel pathogens. reseach was done through publicly available information on the Internet and through network connections at other laboratories
• Cost analysis, verifying that BioFire reagent pricing aligns with industry standards.
| Q6Yes: |
| Q6No: |
| Q6NA: |
| Q7Answer: • Comparison with previous BioFire reagent contracts and publicly available pricing of alternative reagents confirmed that pricing remains consistent with industry standards. |
Item Description / Item Number / Quantity / Unit Cost / Total Cost
• Global Fever Special Pathogens Panel IVD (6 Tests) / DFA2-ASY-0018 / 50 / $1,453.00 / $72,650.00
• BIOFIRE SHIELD Control Kit for Global Fever Special Pathogens Panel (12 Controls) / DFA2-ASY-0019 / 10 $387.00 / $3,870.00
• Gastrointestinal Panel IVD (30 Tests) / RFIT-ASY-0116 / 10 / $4,933.00 / $49,330.00
• Shipping / 25 / $20.00 / $500.00
• FilmArray 2.0 Extended Warranty (1 year coverage for 6 instruments) / FLM1-PRT-0018 / 6 $4,688.00 / $28,128.00
• Total Contract Cost: $154,478.00
These items will be shipped in up to 25 deliveries to the IDPH Chicago and Springfield labs.
| Q8y: |
| Q8n: |
| Q8aAnswer: |
| Q9Answer: The total contract cost of $154,478.00 is justified by: |
• Avoiding downtime: Ensures continued public health emergency response.
• Preventing outbreaks: Timely detection of Ebola, malaria, and gastrointestinal illnesses prevents larger public health crises.
• Maintaining LRN compliance: IDPH labs must follow CDC testing protocols.
• Delays in Testing: IDPH labs would be unable to perform rapid, CDC-compliant testing for Ebola and other high-risk pathogens, jeopardizing outbreak response capabilities.
• Regulatory & LRN Compliance Risks: IDPH could risk losing its LRN status, which requires CDC-approved testing methodologies.
• Hospital Reluctance to Test: As seen during the Fall 2022 Ebola outbreak, hospitals were unwilling to test for malaria and other fever pathogens in suspected Ebola patients due to biosafety restrictions. The BioFire system allows all testing to occur in a BSL-3 environment, resolving this issue.
• Disruption of Existing Testing Infrastructure: BioFire FilmArray 2.0 instruments are already owned and fully operational at IDPH labs. Switching to a different system would cause unnecessary disruptions, additional costs, and prolonged training times.
• Loss of Federal Funding & Public Health Readiness: The inability to conduct CDC-compliant testing could affect IDPH’s eligibility for federal funding related to infectious disease preparedness.
• Not having to repurchase new equipment to utilize an alternative reagent. will save the State of Illinois from having to re-invest $389,189.42 in a completely new systems.
| Q10Answer: |
| SignatureField1: |
| TextField63: Leslie A Chapman |
| TextField63: Leslie.chapman@illinois.gov |
| TextField63: Mike.Caceres@illinois.gov |
| TextField63: Mike Caceres |
| TextField64: 618-457-5131 |
| TextField65: 217-557-7905 |
| Approve: |
| denied: |
| Comments: |
| Phone: 217-299-5883 |
| Date: 03/06/2025 |
| PN: Rebecca Gossett |
| Email: rebecca.gossett@illinois.gov |
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| No: 0 |
| Members: 0 |
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| CPOTelephone: 217-558-2231 |
| CPOPrintedName: Ellen H. Daley |
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File details come from the government source that posted it. Updated .