CPO signed part I and II DPH B-51128.pdf

Sole Source Justification Form

Version 7.01 Page 1 of 8

Bulletin Reference Number 26-482DPH-OFCDI-B-51128

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 / Division of Laboratories

Need Identified Date: 01/01/2026 Supply/Service Need By Date: 05/01/2026

Project Title: BioFire Defense LLC Reagent and Extended Warranty Sole Source

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: 224,918

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: 05/01/2026

Estimated Contract End Date: 10/18/2028

Number of Potential Renewals: 0

Length of Each Renewal in Months: 0

Total Value of All Renewals: 0

If a Term Contract, does the term, including renewals, exceed 12 months? Yes No

If yes, provide a detailed justification including any economic benefit received for agreeing to a multi-year term:

A multi-year term ensures continuity of service for IDPH’s existing BioFire FilmArray® 2.0 instruments, which are essential for rapid pathogen detection and outbreak response. Because these instruments are already in use and validated under CDC and DoD guidelines, the multi-year agreement eliminates the need to purchase and implement new systems, avoiding significant reinvestment costs and operational disruptions. This approach guarantees uninterrupted diagnostic capability and maintains compliance with federal requirements without the expense and delays associated with replacing equipment.

IDPH received reduced pricing from the vendor for a multi-year service agreement covering BioFire FilmArray 2.0 extended warranty service plans, resulting in $2,370.50 in savings per unit per year and generating a total savings of $56,892 across 12 service plans over the multi-year period.

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

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Bulletin Reference Number 26-482DPH-OFCDI-B-51128

Requesting Agency/University Illinois Department of Public Health (IDPH)

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

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 05/01/2025 04/30/2026 154,478 BioFire Defense, LLC Reagent and Service (1 year). 58500022M Sole Source

2 05/01/2024 04/30/2025 88,466 BioFire Defense, LLC Reagent and Service. Small Purchase with Sole Source Conditions (1 year)

485000028L Small Purchase

3 05/01/2023 04/30/2024 98,948 BioFire Defense, LLC Reagent and Service. Small Purchase with Sole Source Conditions (1 year)

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 test kits, reagents, and associated consumables to perform rapid molecular diagnostic testing on its existing BioFire FilmArray® 2.0 instruments. These instruments cannot function without these proprietary items, as they are essential for processing samples and generating accurate results. In addition to consumables, the purchase includes software, maintenance, and technical support services provided exclusively by BioFire Defense. These services are critical for the operation and upkeep of the instruments, ensuring they remain compliant with CDC and DoD guidelines and capable of supporting Laboratory Response Network (LRN) testing protocols. Without these reagents and support services, IDPH laboratories would be unable to conduct required testing for high-consequence pathogens such as Ebola, malaria, and other febrile illnesses, jeopardizing outbreak response and public health readiness.

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Bulletin Reference Number 26-482DPH-OFCDI-B-51128

Requesting Agency/University Illinois Department of Public Health (IDPH)

2. Provide a list and describe in detail the specifications required to satisfy the need:

The Illinois Department of Public Health (IDPH) requires these specific BioFire reagents, consumables, and warranty services because they are the only products compatible with the BioFire FILMARRAY® 2.0 instruments currently deployed in IDPH laboratories. These instruments were purchased under CDC Laboratory Response Network (LRN) guidelines and are validated for use with BioFire’s proprietary panels. No other manufacturer’s reagents or service agreements can operate on this platform.

Procurement of BioFire reagents (Global Fever, SHIELD controls, Gastrointestinal, Respiratory Panel 2.1), shipping, and extended warranty coverage for twelve (12) FilmArray 2.0 instruments to support IDPH laboratory operations over a multi-year term.

Description/Item Number

• BioFire Global Fever Special Pathogens Panel/DFA2-ASY-0018

• Control Kit for the Global Fever Special Pathogens Panel/ DFA2-ASY-0019

• Gastrointestinal Panel/ RFIT-ASY-0116

• Respiratory Panel 2.1/ 423742

• Shipping and Handling costs for item listed above.

These items will be shipped in up to 25 deliveries to the IDPH Chicago and Springfield labs.)

• FilmArray 2.0 Extended Warranty (period instruments covered listed below) / FLM1-PRT-0018

• List of FilmArray 2.0 Extended Warranty Instrument Serial Number / Dates of Coverage / Instrument Location

• 2FA07914 / 10/6/2026 - 10/5/2028 / IDPH Chicago Laboratory 2121 W Taylor St, Chicago, IL 60612

• 2FA09885 / 10/6/2026 - 10/5/2028 / IDPH Chicago Laboratory 2121 W Taylor St, Chicago, IL 60612

• 2FA09810 / 10/19/2026 - 10/18/2028 / IDPH Chicago Laboratory 2121 W Taylor St, Chicago, IL 60612

• 2FA09859 / 10/13/2026 - 10/12/2028 / IDPH Springfield Laboratory 825 N Rutledge, Springfield, IL 62702

• 2FA09890 / 10/13/2026 - 10/12/2028 / IDPH Springfield Laboratory 825 N Rutledge, Springfield, IL 62702

• 2FA09760 / 10/18/2026 - 10/17/2028 / IDPH Springfield Laboratory 825 N Rutledge, Springfield, IL 62702

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Bulletin Reference Number 26-482DPH-OFCDI-B-51128

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).

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Bulletin Reference Number 26-482DPH-OFCDI-B-51128

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, 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. Research was done through publicly available information on the Internet and through network connections at other laboratories. This research was conducted in late 2022 using publicly available information and professional laboratory networks and is verified annually with federal partners.

• Cost analysis, verifying that BioFire reagent pricing aligns with industry standards.

6. Are there resellers or distributors?

Yes No N/A

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Bulletin Reference Number 26-482DPH-OFCDI-B-51128

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.

Procurement of BioFire reagents (Global Fever, SHIELD controls, Gastrointestinal, Respiratory Panel 2.1), shipping, and extended warranty coverage for twelve (12) FilmArray 2.0 instruments to support IDPH laboratory operations over a two-year term.

Description/Item Number Cost Per Unit x Total Quantity = Total Amount

• BioFire Global Fever Special Pathogens Panel/DFA2-ASY-0018 $1,453.00 x 50 = $72,650

• Control Kit for the Global Fever Special Pathogens Panel/DFA2-ASY-0019 $387.00 x 20 = $7,740

• Gastrointestinal Panel/RFIT-ASY-0116 $4,933.00 x 4 = $19,732

• Respiratory Panel 2.1/423742 $4,296.00 x 16 = $68,736

• Shipping and Handling costs for item listed above $220.00 x 2 = $440.00

• FilmArray 2.0 Extended Warranty (period instruments covered listed below) / FLM1-PRT-0018

• List of FilmArray 2.0 Extended Warranty Instrument Serial Number / Dates of Coverage / Instrument Location

• 2FA07914 / 10/6/2026 - 10/5/2028 / IDPH Chicago Laboratory 2121 W Taylor St, Chicago, IL 60612

• 2FA09885 / 10/6/2026 - 10/5/2028 / IDPH Chicago Laboratory 2121 W Taylor St, Chicago, IL 60612

• 2FA09810 / 10/19/2026 - 10/18/2028 / IDPH Chicago Laboratory 2121 W Taylor St, Chicago, IL 60612

• 2FA09859 / 10/13/2026 - 10/12/2028 / IDPH Springfield Laboratory 825 N Rutledge, Springfield, IL 62702

• 2FA09890 / 10/13/2026 - 10/12/2028 / IDPH Springfield Laboratory 825 N Rutledge, Springfield, IL 62702

• 2FA09760 / 10/18/2026 - 10/17/2028 / IDPH Springfield Laboratory 825 N Rutledge, Springfield, IL 62702

• Total Contract Cost: $224,918

These items will be shipped in up to 25 deliveries to the IDPH Chicago and Springfield labs.

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?

If this sole source is not approved and a competitive bid is required, the Illinois Department of Public Health (IDPH) would face a critical inability to perform rapid molecular diagnostic testing for high-consequence pathogens such as Ebola, malaria, and other febrile illnesses. The BioFire FilmArray® 2.0 instruments currently in use cannot operate without BioFire-specific test kits, reagents, consumables, and associated software and maintenance services. Without these items, IDPH laboratories would be unable to provide essential testing to hospitals and the public, severely compromising outbreak response and public health readiness. This would result in delays in detecting and containing infectious diseases, increased risk of community spread, and potential loss of Laboratory Response Network (LRN) compliance, which could jeopardize federal funding. Additionally, requiring a competitive bid would not yield viable alternatives because no other vendor offers CDC- and DoD-approved reagents compatible with IDPH’s existing instruments. The inability to procure these supplies would disrupt critical testing infrastructure and prevent IDPH from fulfilling its core mission of protecting the health of Illinois residents

10. Is there any additional information you would like to add to justify this sole source?

NA

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Bulletin Reference Number 26-482DPH-OFCDI-B-51128

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 19, 2026

Printed Name Leslie 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

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 03/19/2026

Printed Name Rebecca Gossett E-mail Address rebecca.gossett@illinois.gov

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Bulletin Reference Number 26-482DPH-OFCDI-B-51128

Requesting Agency/University Illinois Department of Public Health (IDPH)

Sole Source Justification Form - Part II Section I - General Information

Project Title BioFire Defense LLC Reagent and Extended Warranty Sole Source

Vendor BioFire Defense, LLC

Initial Date of Procurement Bulletin Posting 03/24/2026

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 217-622-1857

Printed Name Ellen H. Daley Date Apr 9, 2026

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

IDPH received reduced pricing from the vendor for a multi‑year service agreement covering BioFire FilmArray 2.0 extended warranty service plans, resulting in $2,370.50 in savings per unit per year and generating a total savings of $56,892 across 12 service plans over the multi-year period.

Procurement of BioFire reagents (Global Fever, SHIELD controls, Gastrointestinal, Respiratory Panel 2.1), shipping, and extended warranty coverage for twelve (12) FilmArray 2.0 instruments to support IDPH laboratory operations over a multi-year term.

Description/Item Number

• BioFire Global Fever Special Pathogens Panel/DFA2-ASY-0018

• Control Kit for the Global Fever Special Pathogens Panel/ DFA2-ASY-0019

• Gastrointestinal Panel/ RFIT-ASY-0116

• Respiratory Panel 2.1/ 423742

• Shipping and Handling costs for item listed above.

These items will be shipped in up to 25 deliveries to the IDPH Chicago and Springfield labs.)

• FilmArray 2.0 Extended Warranty (period instruments covered listed below) / FLM1-PRT-0018

• List of FilmArray 2.0 Extended Warranty Instrument Serial Number / Dates of Coverage / Instrument Location

• 2FA07914 / 10/6/2026 - 10/5/2028 / IDPH Chicago Laboratory 2121 W Taylor St, Chicago, IL 60612

• 2FA09885 / 10/6/2026 - 10/5/2028 / IDPH Chicago Laboratory 2121 W Taylor St, Chicago, IL 60612

• 2FA09810 / 10/19/2026 - 10/18/2028 / IDPH Chicago Laboratory 2121 W Taylor St, Chicago, IL 60612

• 2FA09859 / 10/13/2026 - 10/12/2028 / IDPH Springfield Laboratory 825 N Rutledge, Springfield, IL 62702

• 2FA09890 / 10/13/2026 - 10/12/2028 / IDPH Springfield Laboratory 825 N Rutledge, Springfield, IL 62702

• 2FA09760 / 10/18/2026 - 10/17/2028 / IDPH Springfield Laboratory 825 N Rutledge, Springfield, IL 62702 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.

• 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, 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. Research was done through publicly available information on the Internet and through network connections at other laboratories. This research was conducted in late 2022 using publicly available information and professional laboratory networks and is verified annually with federal partners.

• Cost analysis, verifying that BioFire reagent pricing aligns with industry standards.

Procurement of BioFire reagents (Global Fever, SHIELD controls, Gastrointestinal, Respiratory Panel 2.1), shipping, and extended warranty coverage for twelve (12) FilmArray 2.0 instruments to support IDPH laboratory operations over a two‑year term.

Description/Item Number Cost Per Unit x Total Quantity = Total Amount

• BioFire Global Fever Special Pathogens Panel/DFA2-ASY-0018 $1,453.00 x 50 = $72,650

• Control Kit for the Global Fever Special Pathogens Panel/DFA2-ASY-0019 $387.00 x 20 = $7,740

• Gastrointestinal Panel/RFIT-ASY-0116 $4,933.00 x 4 = $19,732

• Respiratory Panel 2.1/423742 $4,296.00 x 16 = $68,736

• Shipping and Handling costs for item listed above $220.00 x 2 = $440.00

• FilmArray 2.0 Extended Warranty (period instruments covered listed below) / FLM1-PRT-0018

• List of FilmArray 2.0 Extended Warranty Instrument Serial Number / Dates of Coverage / Instrument Location

• 2FA07914 / 10/6/2026 - 10/5/2028 / IDPH Chicago Laboratory 2121 W Taylor St, Chicago, IL 60612

• 2FA09885 / 10/6/2026 - 10/5/2028 / IDPH Chicago Laboratory 2121 W Taylor St, Chicago, IL 60612

• 2FA09810 / 10/19/2026 - 10/18/2028 / IDPH Chicago Laboratory 2121 W Taylor St, Chicago, IL 60612

• 2FA09859 / 10/13/2026 - 10/12/2028 / IDPH Springfield Laboratory 825 N Rutledge, Springfield, IL 62702

• 2FA09890 / 10/13/2026 - 10/12/2028 / IDPH Springfield Laboratory 825 N Rutledge, Springfield, IL 62702

• 2FA09760 / 10/18/2026 - 10/17/2028 / IDPH Springfield Laboratory 825 N Rutledge, Springfield, IL 62702

• Total Contract Cost: $224,918

These items will be shipped in up to 25 deliveries to the IDPH Chicago and Springfield labs.