CPO signed part I and II DPH B-49031.pdf
PDF 895 KB Posted
- Contract number
- 25-482DPH-OFCDI-P-87944
- Issued by
- Illinois
About this file
This is a Sole Source Justification Form (Bulletin Reference Number 25-482DPH-OFCDI-B-49031) submitted by the Illinois Department of Public Health, Office of Disease Control, Division of Laboratories to procure equipment service coverage, reagents, and consumables from Clear Labs, Inc. The justification was posted on September 9, 2025, and approved by the State Purchasing Officer Rebecca Gossett on September 4, 2025, and by the Chief Procurement Officer Ellen H. Daley on September 24, 2025.
The contract covers service maintenance and supplies for two Clear Dx™ System LR-SR instruments owned by the Illinois Department of Public Health Division of Laboratories, with a contract value of $859,656 for a one-year term from December 6, 2025, through December 5, 2026. The procurement includes two Clear Dx System Service Plans at $29,988 each (one for each instrument located in Chicago and Springfield), 110 units of Clear Dx WGS SARS-CoV-2 Reagent v3.0 at $3,688 per unit, 195 units of Clear Dx Microbial Surveillance WGS Reagent v2.0 at $2,000 per unit, and shipping costs of $400. The funding source is Federal Funds. The sole source justification is based on patent and copyright protections, as the Clear Dx™ System is proprietary to Clear Labs, Inc., with no compatible alternative vendors or third-party resellers available. The procurement includes no renewal periods or options. The purchase history indicates IDPH-DOL has continuously procured these services since April 2023, with prior contracts totaling approximately $3.6 million.
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Sole Source Justification Form
Version 7.01 Page 1 of 8
Bulletin Reference Number 25-482DPH-OFCDI-B-49031
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 / Office of Disease Control / Division of Labs
Need Identified Date: 3/31/2025 Supply/Service Need By Date: 12/06/2025
Project Title: Clear Dx Instrument, Service and Reagent Sole Source
Vendor: Clear Labs, Inc
Provide a description of the supplies or services required:
This request is for a sole source contract to procure service coverage for two Clear Dx™ System LR-SR instruments and Clear Dx™ System reagents and consumables for Clear Labs Instruments owned by the Illinois Department of Public Health Division of Laboratories (IDPH-DOL).
Value: Actual Value of Initial Term, this Change Order or Amendment: 859,656
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: 12/06/2025
Estimated Contract End Date: 12/05/2026
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
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
Version 7.01 Page 2 of 8
Bulletin Reference Number 25-482DPH-OFCDI-B-49031
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 07/31/2025 12/05/2025 19,242.3 Clear Dx Service Plan 58500035M Small Purchase
2 12/05/2024 12/04/2025 1,632,476 Clear Dx Commodities and equipment 58500012M Sole Source
3 01/12/2024 01/11/2025 1,004,000 Clear Dx Instrument and Reagents 48500016L Sole Source
4 04/01/2023 04/01/2024 962,476 Clear Dx Instrument and Reagents 38500028K Sole Source
5 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 a sole source procurement for service coverage, as well as reagents and consumables, for two Clear Dx™ System LR-SR instruments currently owned by the Department.
The Clear Dx™ System, developed by Clear Labs, Inc., is a next-generation sequencing (NGS) platform used by IDPH-DOL to conduct molecular testing and genomic analysis related to public health surveillance and laboratory functions.
Molecular testing and genomic analysis conducted by IDPH-DOL are central to our public health surveillance efforts. We analyze sample relatedness to assist state epidemiologists in identifying outbreaks. This data is compiled into reports that are shared with laboratories and local health departments to facilitate follow-up with individuals who have adverse test results.
Public health surveillance is the ongoing, systematic collection, analysis, interpretation, and dissemination of data regarding a health-related event or condition. This process is crucial for identifying and tracking diseases, monitoring health trends, and informing public health interventions. Essentially, it's about gathering the right information, understanding it, and using it to protect and improve the health of populations.
These instruments require the use of proprietary reagents and consumables produced by Clear Labs, Inc. The system is designed and validated to operate with these specific components. Use of alternate reagents or consumables would not be compatible with the manufacturer’s specifications.
The Clear Dx™ System includes automation features that integrate multiple steps of the NGS workflow, including sample preparation, sequencing, and data analysis. The use of this system reduces manual processing steps and allows for standardized sequencing protocols.
IDPH-DOL uses these instruments to support ongoing laboratory testing activities. The procurement of associated reagents, consumables, and service coverage is required to maintain operational use of the systems.
Version 7.01 Page 3 of 8
Bulletin Reference Number 25-482DPH-OFCDI-B-49031
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 two 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.
• Clear Dx™ System Service Plan – 1 Year
• Product Number: 850071
• Quantity: 2 (One for each instrument: Chicago – Serial Number BFGL2; Springfield – Serial Number BFGL11)
• Term: 12/6/2025 to 12/5/2026
• Description: Annual service coverage for both Clear Dx™ instruments. Includes preventive maintenance, instrument calibration, and repair services to ensure continued functionality.
• Clear Dx™ WGS SARS-CoV-2 Reagent v3.0 and Automation Bundle
• Product Number: 900005
• Quantity: 110
• Term: 12/6/2025 to 12/5/2026
• Description: Reagents and automation materials required for whole genome sequencing (WGS) of SARS-CoV-2 specimens using the Clear Dx™ platform.
• Clear Dx™ Microbial Surveillance WGS Reagent v2.0 and Automation Bundle
• Product Number: 900015
• Quantity: 195
• Term: 12/6/2025 to 12/5/2026
• Description: Reagents and automation materials required for whole genome sequencing (WGS) of microbial pathogens used in surveillance activities.
• Shipping
• Product Number: CL-IS Central
• Quantity: 10
• Term: 12/6/2025 to 12/5/2026
• Description: Shipping costs associated with the delivery of reagents and consumables listed above.
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, which is currently owned and in use by the Illinois Department of Public Health – Division of Laboratories (IDPH-DOL). The Clear Dx™ platform is a proprietary system developed by Clear Labs, Inc., and no other vendor offers compatible service coverage, reagents, or consumables.
The Clear Dx™ System is the only fully automated platform currently available that combines intelligent library preparation, Next- Generation Sequencing (NGS), and automated post-sequence analysis into a single integrated system. It is also the only system on the market capable of performing whole genome sequencing of both SARS-CoV-2 and bacterial isolates (microbial surveillance) within a single workflow.
This system performs automated bacterial isolate sample extraction, WGS, and analysis within approximately 18 hours from the time of raw sample loading. This integrated and time-efficient functionality is necessary to meet the laboratory's operational timelines for real-time genomic surveillance.
Due to the proprietary nature of the platform, including reagents, software, and hardware components, only Clear Labs, Inc. can provide the service plans, reagents, and consumables that are certified and validated for use with the existing Clear Dx™ instruments.
Use of alternate products or services would not be compatible with the instruments and would risk non-compliance with regulatory and operational requirements.
Version 7.01 Page 4 of 8
Bulletin Reference Number 25-482DPH-OFCDI-B-49031
Requesting Agency/University Illinois Department of Public Health
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, in the United States. These components are proprietary and specifically engineered to function with the Clear Dx™ platform.
Key unique features include:
• Exclusive Compatibility: The reagents and consumables are designed and validated solely for use with the Clear Dx™ system and are not available from third-party suppliers.
• Integrated Automation: The Clear Dx™ platform performs automated sample extraction, library preparation, sequencing, and bioinformatic analysis in a single instrument with minimal manual input.
• Time Efficiency: The system delivers whole genome sequencing results within approximately 18 hours from raw sample input for both SARS-CoV-2 and bacterial isolates. No other system offers this full workflow integration at this speed.
• Vendor Exclusivity: There are no authorized third-party resellers or distributors of Clear Dx™ service plans or reagents. All purchases and service agreements must be made directly with Clear Labs, Inc.
These features are critical to maintaining uninterrupted laboratory operations, regulatory compliance, and data quality standards required for public health genomic surveillance.
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, along with the associated reagents and consumables, within the United States.
Due to the proprietary nature of the Clear Dx™ platform, no alternative vendors are capable of supplying compatible components or support services. All system components—hardware, software, reagents, and consumables—are designed to function exclusively with each other. Evaluating alternative suppliers was not applicable because there are no compatible third-party products or services available in the market.
Relying on a single integrated system from one vendor ensures operational consistency and eliminates potential complications related to compatibility, validation, or regulatory compliance that could arise from integrating multiple systems or sourcing from different vendors.
6. Are there resellers or distributors?
Yes No N/A
Version 7.01 Page 5 of 8
Bulletin Reference Number 25-482DPH-OFCDI-B-49031
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.
• Cross-State Price Validation: Although Clear Labs, Inc. does not publicly publish pricing, IDPH-DOL has engaged with other state public health laboratories currently using the Clear Dx™ platform. These inquiries confirmed that the pricing offered to IDPH is consistent with what other states have paid, providing an external reference point for price competitiveness.
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 procurement is for the purchase of the following items:
• 850071 Clear Dx System Service Plan - 1 year , instrument located in Chicago instrument serial number: BFGL21. Period: 12/6/2025 to 12/5/2026. Price: 29,988.00 each.
• 850071 Clear Dx System Service Plan - 1 year, instrument located in Springfield instrument serial number: BFGL11 Period: 12/6/2025 to 12/5/2026. Price:$29,988.00 each.
• 900005 Clear Dx™ WGS SARS-CoV-2 Reagent v3.0 and Automation Bundle. Price: $3,688.00 each. Total Quantity 110.
• 900015 Clear Dx™ Microbial Surveillance WGS Reagent v2.0 & Automation Bundle. Price: $2,000.00 each. Total Quantity 195.
• CL-IS Central Shipping $400.00
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?
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.
• The Clear Dx™ platform includes automation that minimizes manual handling of samples, reducing error risk and maintaining sample integrity in a closed system. Losing access to this system would require reverting to more labor-intensive and time-consuming workflows, leading to increased staffing costs and reduced efficiency.
• 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.
Version 7.01 Page 6 of 8
Bulletin Reference Number 25-482DPH-OFCDI-B-49031
Requesting Agency/University Illinois Department of Public Health
10. Is there any additional information you would like to add to justify this sole source?
No
Version 7.01 Page 7 of 8
Bulletin Reference Number 25-482DPH-OFCDI-B-49031
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 Sep 4, 2025
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 Sep 4, 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 09/04/2025
Printed Name Rebecca Gossett E-mail Address rebecca.gossett@illinois.gov
Version 7.01 Page 8 of 8
Bulletin Reference Number 25-482DPH-OFCDI-B-49031
Requesting Agency/University Illinois Department of Public Health
Sole Source Justification Form - Part II Section I - General Information
Project Title Clear Dx Instrument, Service and Reagent Sole Source
Vendor Clear Labs, Inc
Initial Date of Procurement Bulletin Posting 09/09/2025
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 Sep 24, 2025
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-49031 |
| Requesting: Illinois Department of Public Health |
| CurrentPage: |
| PageCount: |
| Department: Illinois Department of Public Health / Office of Disease Control / Division of Labs |
| NeedIdentifiedDate: 3/31/2025 |
| NeedbyDate: 12/06/2025 |
| ProjectTitle: Clear Dx Instrument, Service and Reagent Sole Source |
| ProjectTitle: Clear Dx Instrument, Service and Reagent Sole Source |
| Vendor: Clear Labs, Inc |
| Vendor: Clear Labs, Inc |
| Description: This request is for a sole source contract to procure service coverage for two Clear Dx™ System LR-SR instruments and Clear Dx™ System reagents and consumables for Clear Labs Instruments owned by the Illinois Department of Public Health Division of Laboratories (IDPH-DOL). |
| ValueIs: Actual |
| ValueofInitialTerm: 859656.00000000 |
| P-Ayes: |
| P-Ano: |
| P-AValue: |
| ThisIsA: New Sole Source |
| One-Time: |
| Term: |
| BeginDate: 12/06/2025 |
| EndDate: 12/05/2026 |
| NumberofRenewals: 0.00000000 |
| RenewalLength: 0.00000000 |
| RenewalValue: 0.00000000 |
| ExceedingYes: |
| ExceedingNo: |
| TextField3: |
| StateFunds: 0 |
| FederalFunds: 1 |
| FundingOther: 0 |
| TextField4: Clear Dx Service Plan |
| DropDownList1: Items are Copyrighted or Patented and the Items are Only Available from the Holder |
| DropDownList1: Small Purchase |
| DropDownList1: Sole Source |
| DropDownList1: Sole Source |
| DropDownList1: Sole Source |
| DropDownList1: Sole Source |
| Justify: |
| PastYes: |
| PastNo: |
| DateTimeField20: 07/31/2025 |
| DateTimeField19: 12/05/2025 |
| NumericField8: 19242.30000000 |
| TextField5: 58500035M |
| DateTimeField18: 12/05/2024 |
| DateTimeField17: 12/04/2025 |
| NumericField9: 1632476.00000000 |
| TextField10: Clear Dx Commodities and equipment |
| TextField11: 58500012M |
| DateTimeField16: 01/12/2024 |
| DateTimeField15: 01/11/2025 |
| NumericField10: 1004000.00000000 |
| TextField16: Clear Dx Instrument and Reagents |
| TextField17: 48500016L |
| DateTimeField14: 04/01/2023 |
| DateTimeField13: 04/01/2024 |
| NumericField11: 962476.00000000 |
| TextField22: Clear Dx Instrument and Reagents |
| TextField23: 38500028K |
| DateTimeField12: |
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| DateTimeField4: 2025-09-04 |
| DateTimeField4: 2025-09-04 |
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| Q1Answer: The Illinois Department of Public Health – Division of Laboratories (IDPH-DOL) is requesting a sole source procurement for service coverage, as well as reagents and consumables, for two Clear Dx™ System LR-SR instruments currently owned by the Department. |
The Clear Dx™ System, developed by Clear Labs, Inc., is a next-generation sequencing (NGS) platform used by IDPH-DOL to conduct molecular testing and genomic analysis related to public health surveillance and laboratory functions.
Molecular testing and genomic analysis conducted by IDPH-DOL are central to our public health surveillance efforts. We analyze sample relatedness to assist state epidemiologists in identifying outbreaks. This data is compiled into reports that are shared with laboratories and local health departments to facilitate follow-up with individuals who have adverse test results.
Public health surveillance is the ongoing, systematic collection, analysis, interpretation, and dissemination of data regarding a health-related event or condition. This process is crucial for identifying and tracking diseases, monitoring health trends, and informing public health interventions. Essentially, it's about gathering the right information, understanding it, and using it to protect and improve the health of populations.
These instruments require the use of proprietary reagents and consumables produced by Clear Labs, Inc. The system is designed and validated to operate with these specific components. Use of alternate reagents or consumables would not be compatible with the manufacturer’s specifications.
The Clear Dx™ System includes automation features that integrate multiple steps of the NGS workflow, including sample preparation, sequencing, and data analysis. The use of this system reduces manual processing steps and allows for standardized sequencing protocols.
IDPH-DOL uses these instruments to support ongoing laboratory testing activities. The procurement of associated reagents, consumables, and service coverage is required to maintain operational use of the systems.
Q2Answer: The following products and services are required to support the operation and maintenance of two 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.
• Clear Dx™ System Service Plan – 1 Year
• Product Number: 850071
• Quantity: 2 (One for each instrument: Chicago – Serial Number BFGL2; Springfield – Serial Number BFGL11)
• Term: 12/6/2025 to 12/5/2026
• Description: Annual service coverage for both Clear Dx™ instruments. Includes preventive maintenance, instrument calibration, and repair services to ensure continued functionality.
• Clear Dx™ WGS SARS-CoV-2 Reagent v3.0 and Automation Bundle
• Product Number: 900005
• Quantity: 110
• Term: 12/6/2025 to 12/5/2026
• Description: Reagents and automation materials required for whole genome sequencing (WGS) of SARS-CoV-2 specimens using the Clear Dx™ platform.
• Clear Dx™ Microbial Surveillance WGS Reagent v2.0 and Automation Bundle
• Product Number: 900015
• Quantity: 195
• Term: 12/6/2025 to 12/5/2026
• Description: Reagents and automation materials required for whole genome sequencing (WGS) of microbial pathogens used in surveillance activities.
• Shipping
• Product Number: CL-IS Central
• Quantity: 10
• Term: 12/6/2025 to 12/5/2026
• Description: Shipping costs associated with the delivery of reagents and consumables listed above.
Q3Answer: The requested supplies and services are specific to the Clear Dx™ System, which is currently owned and in use by the Illinois Department of Public Health – Division of Laboratories (IDPH-DOL). The Clear Dx™ platform is a proprietary system developed by Clear Labs, Inc., and no other vendor offers compatible service coverage, reagents, or consumables.
The Clear Dx™ System is the only fully automated platform currently available that combines intelligent library preparation, Next-Generation Sequencing (NGS), and automated post-sequence analysis into a single integrated system. It is also the only system on the market capable of performing whole genome sequencing of both SARS-CoV-2 and bacterial isolates (microbial surveillance) within a single workflow.
This system performs automated bacterial isolate sample extraction, WGS, and analysis within approximately 18 hours from the time of raw sample loading. This integrated and time-efficient functionality is necessary to meet the laboratory's operational timelines for real-time genomic surveillance.
Due to the proprietary nature of the platform, including reagents, software, and hardware components, only Clear Labs, Inc. can provide the service plans, reagents, and consumables that are certified and validated for use with the existing Clear Dx™ instruments. Use of alternate products or services would not be compatible with the instruments and would risk non-compliance with regulatory and operational requirements.
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, in the United States. These components are proprietary and specifically engineered to function with the Clear Dx™ platform.
Key unique features include:
• Exclusive Compatibility: The reagents and consumables are designed and validated solely for use with the Clear Dx™ system and are not available from third-party suppliers.
• Integrated Automation: The Clear Dx™ platform performs automated sample extraction, library preparation, sequencing, and bioinformatic analysis in a single instrument with minimal manual input.
• Time Efficiency: The system delivers whole genome sequencing results within approximately 18 hours from raw sample input for both SARS-CoV-2 and bacterial isolates. No other system offers this full workflow integration at this speed.
• Vendor Exclusivity: There are no authorized third-party resellers or distributors of Clear Dx™ service plans or reagents. All purchases and service agreements must be made directly with Clear Labs, Inc.
These features are critical to maintaining uninterrupted laboratory operations, regulatory compliance, and data quality standards required for public health genomic surveillance.
| altYes: |
| altNo: |
| Q5aAnswer: Clear Labs, Inc. is the only manufacturer and authorized supplier of the Clear Dx™ System Service Plan, along with the associated reagents and consumables, within the United States. |
Due to the proprietary nature of the Clear Dx™ platform, no alternative vendors are capable of supplying compatible components or support services. All system components—hardware, software, reagents, and consumables—are designed to function exclusively with each other. Evaluating alternative suppliers was not applicable because there are no compatible third-party products or services available in the market.
Relying on a single integrated system from one vendor ensures operational consistency and eliminates potential complications related to compatibility, validation, or regulatory compliance that could arise from integrating multiple systems or sourcing from different vendors.
| Q5bAnswer: |
| Q5cAnswer: |
| Q6Yes: |
| Q6No: |
| Q6NA: |
| Q7Answer: 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.
• Cross-State Price Validation: Although Clear Labs, Inc. does not publicly publish pricing, IDPH-DOL has engaged with other state public health laboratories currently using the Clear Dx™ platform. These inquiries confirmed that the pricing offered to IDPH is consistent with what other states have paid, providing an external reference point for price competitiveness.
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 procurement is for the purchase of the following items:
• 850071 Clear Dx System Service Plan - 1 year , instrument located in Chicago instrument serial number: BFGL21. Period: 12/6/2025 to 12/5/2026. Price: 29,988.00 each.
• 850071 Clear Dx System Service Plan - 1 year, instrument located in Springfield instrument serial number: BFGL11 Period: 12/6/2025 to 12/5/2026. Price:$29,988.00 each.
• 900005 Clear Dx™ WGS SARS-CoV-2 Reagent v3.0 and Automation Bundle. Price: $3,688.00 each. Total Quantity 110.
• 900015 Clear Dx™ Microbial Surveillance WGS Reagent v2.0 & Automation Bundle. Price: $2,000.00 each. Total Quantity 195.
• CL-IS Central Shipping $400.00
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| Q9Answer: 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.
• The Clear Dx™ platform includes automation that minimizes manual handling of samples, reducing error risk and maintaining sample integrity in a closed system. Losing access to this system would require reverting to more labor-intensive and time-consuming workflows, leading to increased staffing costs and reduced efficiency.
• 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.
| Q10Answer: No |
| SignatureField1: |
| TextField63: Leslie Chapman |
| TextField63: leslie.chapman@illinois.gov |
| TextField63: mike.caceres@illinois.gov |
| TextField63: Mike Caceres |
| TextField64: 618-457-5131 |
| TextField65: 217-577-7905 |
| Approve: |
| denied: |
| Comments: |
| Phone: 217-299-5883 |
| Date: 09/04/2025 |
| Date: 2025-09-24 |
| PN: Rebecca Gossett |
| Email: rebecca.gossett@illinois.gov |
| InitialPostingDate: 09/09/2025 |
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| WrittenComments: 0 |
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| CPOTelephone: 217-622-1857 |
| CPOPrintedName: Ellen H. Daley |
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File details come from the government source that posted it. Updated .