Sole Source Justification Form

Version 7.01 Page 1 of 9

Bulletin Reference Number 27-482DPH-OFCDI-B-53556

Requesting Agency/University Illinois Department of Public Health

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

Department/Bureau/Section: Illinois Department of Public Health Division of Laboratories (IDPH-DOL)

Need Identified Date: Jul 23, 2026 Supply/Service Need By Date: 12/06/2026

Project Title: Clear Dx Instrument Service Plans and Clear Dx Reagents Procurement

Vendor: Clear Labs, Inc.

Provide a description of the supplies or services required:

The Illinois Department of Public Health Division of Laboratories (IDPH-DOL) seeks approval for a multi-year sole source contract with Clear Labs, Inc. to provide service plans, reagents, and consumables for multiple Clear Dx™ instruments located in both Chicago and Springfield. These instruments support high-throughput sequencing workflows essential to public health surveillance and outbreak response.

Value: Not to Exceed Value of Initial Term, this Change Order or Amendment: 1,904,475.72

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

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Bulletin Reference Number 27-482DPH-OFCDI-B-53556

Requesting Agency/University Illinois Department of Public Health

Section II - Proposed Term

One-Time Purchase Term Contract

Estimated Contract Begin Date: Dec 6, 2026

Estimated Contract End Date: Dec 5, 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 contract with Clear Labs, Inc. is operationally necessary because the Clear Dx™ platform is the only validated system compatible with IDPH’s existing instruments, and all required reagents, consumables, software, and service plans are proprietary to Clear Labs and not available through any alternative supplier. Without a multi year agreement, IDPH would face recurring risk of supply interruptions, lapses in instrument service coverage, and inconsistent access to essential materials, any of which would cause immediate disruptions in genomic sequencing capacity statewide. Multi year continuity is critical to maintain uninterrupted testing for PulseNet bacterial isolates, SARS CoV 2, Mycobacterium tuberculosis, and antimicrobial resistant organisms, all of which rely on timely, high throughput workflows that Clear Dx™ uniquely supports.

A multi year contract also ensures stable pricing, predictable budgeting across fiscal years, and reduced administrative burden by eliminating the need for frequent renewals for reagents and service plans. This stability preserves annual sequencing capacity and the approximately 100 days of manual technologist time saved per laboratory each year, allowing staff to be reallocated to other essential testing needs. Maintaining operational continuity through a multi year procurement directly supports IDPH DOL’s mission by ensuring rapid turnaround times, standardized workflows, and uninterrupted statewide genomic surveillance essential for public health decision making.

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)

Items are Copyrighted or Patented and the Items are Only Available from the Holder

Are there secondary justification(s) for this sole source? Yes No

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Bulletin Reference Number 27-482DPH-OFCDI-B-53556

Requesting Agency/University Illinois Department of Public Health

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 Dec 6, 2025 Dec 5, 2026 859,656 Clear DX reagents & instrument service plans 6850001M Sole Source

2 Jul 31, 2025 Dec 4, 2025 19,242.3 Clear DX instrument service plans 58500035M Small Purchase

3 Dec 5, 2024 Dec 4, 2025 1,632,476 Clear DX reagents and equipment 58500012M Sole Source

4 Jan 12, 2024 Jan 11, 2025 1,004,000 Clear DX instruments & reagents 48500016L Sole Source

5 Apr 1, 2023 Apr 1, 2024 962,476 Clear DX instruments & reagents 38500028K Sole Source

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 Division of Laboratories (IDPH DOL) is requesting approval for a multi year sole source contract with Clear Labs, Inc. to procure essential reagents, consumables, and manufacturer service coverage required to operate multiple Clear Dx™ sequencing instruments located in both the Chicago and Springfield IDPH laboratories. These instruments support the Division’s whole genome sequencing operations for PulseNet bacterial isolates, SARS CoV 2, and other public health related pathogens.

This procurement includes the purchase of Clear Dx™ proprietary whole genome sequencing reagent bundles, including the SARS CoV 2 WGS v3.0 and Microbial Surveillance WGS v2.0 kits, as well as shipping for the required consumables. It also includes service plan coverage for four Clear Dx™ instruments across both laboratories. The service plans provide manufacturer certified maintenance, calibration, repair support, and software updates, which are required for continued validated operation of the Clear Dx™ platform.

All reagents and service plans included in this purchase are proprietary components available only through Clear Labs, Inc., and are necessary to maintain uninterrupted sequencing operations and consistent genomic testing workflows for IDPH’s public health surveillance programs.

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Bulletin Reference Number 27-482DPH-OFCDI-B-53556

Requesting Agency/University Illinois Department of Public Health

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

The following products and services are required to support the operation and maintenance of four Clear Dx™ System LR-SR instruments owned by IDPH-DOL. These items are specific to the Clear Dx™ platform and are manufactured and supplied by Clear Labs, Inc.

Laboratory Instrument Service Coverage: Annual service coverage includes manufacturer-certified preventive maintenance, calibration, software updates, and repair support necessary to maintain validated sequencing performance.

Chicago Laboratory Instrument: Instrument BFGL21

• Year 1: 12/06/2026 – 12/05/2027

• Year 2: 12/06/2027 – 12/05/2028

Chicago Laboratory Instrument: Instrument BFGL22

• Year 1: 01/30/2027 – 01/29/2028

• Year 2: 01/30/2028 – 12/05/2028:

Springfield Laboratory Instrument: Instrument BFGL11

• Year 1: 12/06/2026 – 12/05/2027

• Year 2: 12/06/2027 – 12/05/2028

Springfield Laboratory Instrument: Instrument BFLF12

• Year 1: 05/08/2027 – 12/05/2028

• Year 2: 05/08/2028 – 12/05/2028

Clear Dx™ WGS SARS-CoV-2 Reagent v3.0 and Automation Bundle: Reagents and automation materials required for whole genome sequencing (WGS) of SARS-CoV-2 specimens. These components are proprietary to the Clear Dx™ instrument workflow.

Product Number: 900005 Total Quantity: 220 units (110 per year)

• Year 1: Quantity 110 (12/06/26 – 12/05/27)

• Year 2: Quantity 110 (12/06/27 – 12/05/28)

Clear Dx™ Microbial Surveillance WGS Reagent v2.0 and Automation Bundle: Reagents and automation bundles required for microbial pathogen whole genome sequencing used in statewide surveillance activities.

Product Number: 900015 Total Quantity: 430 units (215 per year)

• Year 1: Quantity 215 (12/06/26 – 12/05/27)

• Year 2: Quantity 215 (12/06/27 – 12/05/28)

Because each Clear Dx™ instrument was installed on different dates, the manufacturer warranties and the corresponding annual service coverage periods do not begin uniformly. Clear Labs activates warranty and service coverage based on the instrument’s installation date not the date of purchase.

Shipping Product Number: CL-IS Central Total Quantity: 20 shipments (10 per year)

• Year 1: Quantity 10 (12/06/26 – 12/05/27)

• Year 2: Quantity 10 (12/06/27 – 12/05/28)

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Bulletin Reference Number 27-482DPH-OFCDI-B-53556

Requesting Agency/University Illinois Department of Public Health

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 supplies and services are specific to the Clear Dx™ System LR SR instruments currently owned and operated by the Illinois Department of Public Health Division of Laboratories (IDPH DOL). Clear Labs, Inc. is the sole manufacturer and exclusive provider of the Clear Dx™ platform, including all associated reagents, consumables, software, and service plans. These components are proprietary, and no third party vendors produce compatible products or are authorized to provide maintenance or support for Clear Dx™ instruments.

The Clear Dx™ System uses a fully integrated workflow that combines automated sample extraction, library preparation, whole genome sequencing, and bioinformatic analysis within a closed and validated system. Every component, from individual reagent kits to the software pipelines, is engineered and validated by Clear Labs, Inc. to function exclusively within this platform. Use of alternative reagents or services would render the instruments non operational and would violate manufacturer specifications, established validation parameters, and regulatory expectations for public health sequencing.

Furthermore, IDPH DOL operates multiple Clear Dx™ instruments in both Chicago and Springfield laboratories, requiring a coordinated and consistent reagent supply and manufacturer supported service coverage. Clear Labs, Inc. is the only source capable of providing synchronized service plans tied to each instrument’s operational dates, as reflected in the quoted service periods and prorated coverage terms. These service plans, reagents, and consumables are the only items that maintain validated sequencing workflows, ensure uninterrupted testing capacity, and preserve the integrity of data required for state and federal public health surveillance.

For these reasons, Clear Labs, Inc. is the only vendor able to provide the supplies and services necessary to meet IDPH DOL’s operational, regulatory, and scientific requirements for genomic sequencing.

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:

Clear Labs, Inc. is the sole manufacturer and exclusive authorized supplier of the Clear Dx™ System, including all associated reagents, consumables, software, and service plans required for instrument operation. The Clear Dx™ platform is fully proprietary, and its design, reagents, and analytical systems cannot be substituted or replicated by any other vendor. The following unique features demonstrate why no alternative source can meet the Illinois Department of Public Health Division of Laboratories (IDPH DOL)’s operational requirements:

Exclusive Compatibility and Proprietary Engineering All reagents and service plans are engineered, validated, and manufactured solely by Clear Labs. These components are not available through distributors or third party suppliers. Each reagent kit and automation bundle is chemically and operationally proprietary, and the Clear Dx™ instrumentation will not function with off platform materials.

Manufacturer Controlled Service Coverage All instrument service plans are available only through Clear Labs. Quotes confirm that Clear Labs is the exclusive provider of maintenance, calibration, software updates, and repair services necessary to maintain validated functionality. Service plans are tied to exact instrument serial numbers.

No Authorized Resellers or Alternate Vendors All quotes list Clear Labs, Inc. directly as the vendor, with no indication of third party distribution.

5. Has the Agency or University considered alternative supplies or services to satisfy their need? Yes No

5a. If no, why weren't alternatives evaluated?

Clear Labs, Inc. is the only manufacturer and authorized supplier of the Clear Dx™ System Service Plan and all associated reagents, consumables, software, and hardware used to operate and maintain the Clear Dx™ instruments in the United States. The Agency verified this through the vendor’s formal letter to IDPH confirming its exclusive manufacturing and distribution status for all Clear Dx™ components.

6. Are there resellers or distributors?

Yes No N/A

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Bulletin Reference Number 27-482DPH-OFCDI-B-53556

Requesting Agency/University Illinois Department of Public Health

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?

The Illinois Department of Public Health – Division of Laboratories (IDPH-DOL) has determined that the pricing for this procurement is fair and reasonable based on the following factors:

• Historical Pricing: IDPH-DOL has previously procured Clear Dx™ instruments, reagents, consumables, and service plans from Clear Labs, Inc.. The current pricing is consistent with past procurements, demonstrating price stability over time for comparable goods and services.

• Vendor Exclusivity: Clear Labs, Inc. is the only manufacturer and authorized supplier of the Clear Dx™ System Service Plan and associated reagents and consumables in the United States. These items are proprietary and not available through resellers or alternate sources.

Based on these efforts, IDPH-DOL has concluded that the pricing offered by Clear Labs, Inc. is fair and reasonable for the scope of services and products being procured.

This purchase includes Laboratory Instrument Service Coverage: Chicago Laboratory Instrument: Instrument BFGL21

• Year 1: 12/06/2026 – 12/05/2027 Unit Price: $29,988.00

• Year 2: 12/06/2027 – 12/05/2028 Unit Price: $29,988.00 Chicago Laboratory Instrument: Instrument BFGL22

• Year 1: 01/30/2027 – 01/29/2028 Unit Price: $29,988.00

• Year 2: 01/30/2028 – 12/05/2028: Unit Price: $27,769.72 Springfield Laboratory Instrument: Instrument BFGL11

• Year 1: 12/06/2026 – 12/05/2027 Unit Price: $29,988.00

• Year 2: 12/06/2027 – 12/05/2028 Unit Price: $29,988.00 Springfield Laboratory Instrument: Instrument BFLF12

• Year 1: 05/08/2027 – 12/05/2028 Unit Price: $29,988.00

• Term 2: 05/08/2028 – 12/05/2028 Unit Price: $17,417.70

Clear Dx™ WGS SARS-CoV-2 Reagent v3.0 and Automation Bundle:

Product Number: 900005 Unit Price: $3,688.00 each Total Quantity: 220 units (110 per year)

• Year 1: Quantity 110 (12/06/26 – 12/05/27) Total: $405,680.00

• Year 2: Quantity 110 (12/06/27 – 12/05/28) Total: $405,680.00

Clear Dx™ Microbial Surveillance WGS Reagent v2.0 and Automation Bundle:

Product Number: 900015 Unit Price: $2,000.00 each Total Quantity: 430 units (215 per year)

• Year 1: Quantity 215 (12/06/26 – 12/05/27) Total: $430,000.00

• Year 2: Quantity 215 (12/06/27 – 12/05/28) Total: $430,000.00

Shipping Product Number: CL-IS Central Unit Price: $400.00 eachTotal Quantity: 20 shipments (10 year)

• Year 1: Quantity 10 (12/06/26 – 12/05/27) Total: $4,000.00

• Year 2: Quantity 10 (12/06/27 – 12/05/28) Total: $4,000.00

Two-Year Contract Total: $1,904,475.72

8. Will this purchase obligate the State to this vendor for future purchases such as maintenance, licensing or continuing need?

Yes No

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Bulletin Reference Number 27-482DPH-OFCDI-B-53556

Requesting Agency/University Illinois Department of Public Health

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 request is not approved and a competitive bid is required, the Illinois Department of Public Health Division of Laboratories (IDPH-DOL) would experience the following operational and financial impacts:

• The State would be unable to maintain the Clear Dx™ platform, which is currently used to meet increasing demand for high-throughput genomic sequencing related to public health surveillance and outbreak response.

• Without access to the required service coverage, reagents, and consumables, the Clear Dx™ systems would become inoperable, resulting in delays in processing samples and reporting test results.

• Delays in sequencing and reporting could lead to slower public health response times, which may affect containment, treatment, and mitigation strategies in healthcare and community settings

• The financial impact would include higher operational costs, increased labor expenditures, and the loss of timely, real-time genomic data, all of which would hinder the State’s ability to effectively manage infectious disease threats.

For these reasons, a competitive bid is not feasible without incurring significant risk to public health operations and laboratory efficiency.

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

No

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Bulletin Reference Number 27-482DPH-OFCDI-B-53556

Requesting Agency/University Illinois Department of Public Health

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

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 217-577-7905 Date Aug 25, 2026

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 08/25/2026

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

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Bulletin Reference Number 27-482DPH-OFCDI-B-53556

Requesting Agency/University Illinois Department of Public Health

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

Project Title

Vendor Clear Labs, Inc.

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 217-622-1857

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

A multi year contract also ensures stable pricing, predictable budgeting across fiscal years, and reduced administrative burden by eliminating the need for frequent renewals for reagents and service plans. This stability preserves annual sequencing capacity and the approximately 100 days of manual technologist time saved per laboratory each year, allowing staff to be reallocated to other essential testing needs. Maintaining operational continuity through a multi year procurement directly supports IDPH DOL’s mission by ensuring rapid turnaround times, standardized workflows, and uninterrupted statewide genomic surveillance essential for public health decision making.

This procurement includes the purchase of Clear Dx™ proprietary whole genome sequencing reagent bundles, including the SARS CoV 2 WGS v3.0 and Microbial Surveillance WGS v2.0 kits, as well as shipping for the required consumables. It also includes service plan coverage for four Clear Dx™ instruments across both laboratories. The service plans provide manufacturer certified maintenance, calibration, repair support, and software updates, which are required for continued validated operation of the Clear Dx™ platform.

All reagents and service plans included in this purchase are proprietary components available only through Clear Labs, Inc., and are necessary to maintain uninterrupted sequencing operations and consistent genomic testing workflows for IDPH’s public health surveillance programs.

Q2Answer: The following products and services are required to support the operation and maintenance of four Clear Dx™ System LR-SR instruments owned by IDPH-DOL. These items are specific to the Clear Dx™ platform and are manufactured and supplied by Clear Labs, Inc.

Laboratory Instrument Service Coverage: Annual service coverage includes manufacturer‑certified preventive maintenance, calibration, software updates, and repair support necessary to maintain validated sequencing performance.

Chicago Laboratory Instrument: Instrument BFGL21

• Year 1: 12/06/2026 – 12/05/2027

• Year 2: 12/06/2027 – 12/05/2028

Chicago Laboratory Instrument: Instrument BFGL22

• Year 1: 01/30/2027 – 01/29/2028

• Year 2: 01/30/2028 – 12/05/2028:

Springfield Laboratory Instrument: Instrument BFGL11

• Year 1: 12/06/2026 – 12/05/2027

• Year 2: 12/06/2027 – 12/05/2028

Springfield Laboratory Instrument: Instrument BFLF12

• Year 1: 05/08/2027 – 12/05/2028

• Year 2: 05/08/2028 – 12/05/2028

Clear Dx™ WGS SARS‑CoV‑2 Reagent v3.0 and Automation Bundle: Reagents and automation materials required for whole genome sequencing (WGS) of SARS‑CoV‑2 specimens. These components are proprietary to the Clear Dx™ instrument workflow.

Product Number: 900005 Total Quantity: 220 units (110 per year)

• Year 1: Quantity 110 (12/06/26 – 12/05/27)

• Year 2: Quantity 110 (12/06/27 – 12/05/28)

Clear Dx™ Microbial Surveillance WGS Reagent v2.0 and Automation Bundle: Reagents and automation bundles required for microbial pathogen whole genome sequencing used in statewide surveillance activities.

Product Number: 900015 Total Quantity: 430 units (215 per year)

• Year 1: Quantity 215 (12/06/26 – 12/05/27)

• Year 2: Quantity 215 (12/06/27 – 12/05/28)

Because each Clear Dx™ instrument was installed on different dates, the manufacturer warranties and the corresponding annual service coverage periods do not begin uniformly. Clear Labs activates warranty and service coverage based on the instrument’s installation date not the date of purchase.

Shipping Product Number: CL‑IS Central Total Quantity: 20 shipments (10 per year)

• Year 1: Quantity 10 (12/06/26 – 12/05/27)

• Year 2: Quantity 10 (12/06/27 – 12/05/28) Q3Answer: The requested supplies and services are specific to the Clear Dx™ System LR SR instruments currently owned and operated by the Illinois Department of Public Health Division of Laboratories (IDPH DOL). Clear Labs, Inc. is the sole manufacturer and exclusive provider of the Clear Dx™ platform, including all associated reagents, consumables, software, and service plans. These components are proprietary, and no third party vendors produce compatible products or are authorized to provide maintenance or support for Clear Dx™ instruments.

The Clear Dx™ System uses a fully integrated workflow that combines automated sample extraction, library preparation, whole genome sequencing, and bioinformatic analysis within a closed and validated system. Every component, from individual reagent kits to the software pipelines, is engineered and validated by Clear Labs, Inc. to function exclusively within this platform. Use of alternative reagents or services would render the instruments non operational and would violate manufacturer specifications, established validation parameters, and regulatory expectations for public health sequencing.

Furthermore, IDPH DOL operates multiple Clear Dx™ instruments in both Chicago and Springfield laboratories, requiring a coordinated and consistent reagent supply and manufacturer supported service coverage. Clear Labs, Inc. is the only source capable of providing synchronized service plans tied to each instrument’s operational dates, as reflected in the quoted service periods and prorated coverage terms. These service plans, reagents, and consumables are the only items that maintain validated sequencing workflows, ensure uninterrupted testing capacity, and preserve the integrity of data required for state and federal public health surveillance.

For these reasons, Clear Labs, Inc. is the only vendor able to provide the supplies and services necessary to meet IDPH DOL’s operational, regulatory, and scientific requirements for genomic sequencing.

Q4Answer: Clear Labs, Inc. is the sole manufacturer and exclusive authorized supplier of the Clear Dx™ System, including all associated reagents, consumables, software, and service plans required for instrument operation. The Clear Dx™ platform is fully proprietary, and its design, reagents, and analytical systems cannot be substituted or replicated by any other vendor. The following unique features demonstrate why no alternative source can meet the Illinois Department of Public Health Division of Laboratories (IDPH DOL)’s operational requirements:

Exclusive Compatibility and Proprietary Engineering All reagents and service plans are engineered, validated, and manufactured solely by Clear Labs. These components are not available through distributors or third party suppliers. Each reagent kit and automation bundle is chemically and operationally proprietary, and the Clear Dx™ instrumentation will not function with off platform materials.

Manufacturer Controlled Service Coverage All instrument service plans are available only through Clear Labs. Quotes confirm that Clear Labs is the exclusive provider of maintenance, calibration, software updates, and repair services necessary to maintain validated functionality. Service plans are tied to exact instrument serial numbers.

No Authorized Resellers or Alternate Vendors All quotes list Clear Labs, Inc. directly as the vendor, with no indication of third party distribution.

• Historical Pricing: IDPH-DOL has previously procured Clear Dx™ instruments, reagents, consumables, and service plans from Clear Labs, Inc.. The current pricing is consistent with past procurements, demonstrating price stability over time for comparable goods and services.

• Vendor Exclusivity: Clear Labs, Inc. is the only manufacturer and authorized supplier of the Clear Dx™ System Service Plan and associated reagents and consumables in the United States. These items are proprietary and not available through resellers or alternate sources.

Based on these efforts, IDPH-DOL has concluded that the pricing offered by Clear Labs, Inc. is fair and reasonable for the scope of services and products being procured.

This purchase includes Laboratory Instrument Service Coverage: Chicago Laboratory Instrument: Instrument BFGL21

• Year 1: 12/06/2026 – 12/05/2027 Unit Price: $29,988.00

• Year 2: 12/06/2027 – 12/05/2028 Unit Price: $29,988.00 Chicago Laboratory Instrument: Instrument BFGL22

• Year 1: 01/30/2027 – 01/29/2028 Unit Price: $29,988.00

• Year 2: 01/30/2028 – 12/05/2028: Unit Price: $27,769.72 Springfield Laboratory Instrument: Instrument BFGL11

• Year 1: 12/06/2026 – 12/05/2027 Unit Price: $29,988.00

• Year 2: 12/06/2027 – 12/05/2028 Unit Price: $29,988.00 Springfield Laboratory Instrument: Instrument BFLF12

• Year 1: 05/08/2027 – 12/05/2028 Unit Price: $29,988.00

• Term 2: 05/08/2028 – 12/05/2028 Unit Price: $17,417.70

Clear Dx™ WGS SARS‑CoV‑2 Reagent v3.0 and Automation Bundle:

Product Number: 900005 Unit Price: $3,688.00 each Total Quantity: 220 units (110 per year)

• Year 1: Quantity 110 (12/06/26 – 12/05/27) Total: $405,680.00

• Year 2: Quantity 110 (12/06/27 – 12/05/28) Total: $405,680.00

Clear Dx™ Microbial Surveillance WGS Reagent v2.0 and Automation Bundle:

Product Number: 900015 Unit Price: $2,000.00 each Total Quantity: 430 units (215 per year)

• Year 1: Quantity 215 (12/06/26 – 12/05/27) Total: $430,000.00

• Year 2: Quantity 215 (12/06/27 – 12/05/28) Total: $430,000.00

Shipping Product Number: CL‑IS Central Unit Price: $400.00 eachTotal Quantity: 20 shipments (10 year)

• Year 1: Quantity 10 (12/06/26 – 12/05/27) Total: $4,000.00

• Year 2: Quantity 10 (12/06/27 – 12/05/28) Total: $4,000.00

Two-Year Contract Total: $1,904,475.72

• The State would be unable to maintain the Clear Dx™ platform, which is currently used to meet increasing demand for high-throughput genomic sequencing related to public health surveillance and outbreak response.

• Without access to the required service coverage, reagents, and consumables, the Clear Dx™ systems would become inoperable, resulting in delays in processing samples and reporting test results.

• Delays in sequencing and reporting could lead to slower public health response times, which may affect containment, treatment, and mitigation strategies in healthcare and community settings

• The financial impact would include higher operational costs, increased labor expenditures, and the loss of timely, real-time genomic data, all of which would hinder the State’s ability to effectively manage infectious disease threats.

For these reasons, a competitive bid is not feasible without incurring significant risk to public health operations and laboratory efficiency.