Sole Source Justification_IDT CF NGS (1).docx
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- Attached to
- Integrated DNA Technologies NBS CF Reagents
- Solicitation number
- NPSS1 FHCA 2026000180 1
- Issued by
- Denver County, Denver City, Colorado
About this file
This is a Sole Source Justification Form submitted by the Colorado Department of Public Health and Environment, Laboratory Services Division, for the Colorado Newborn Screening Program seeking to procure sequencing library preparation reagents from Integrated DNA Technologies (IDT). The procurement involves the xGen CFTR Amplicon kit, a proprietary product manufactured exclusively by IDT, which is used for NGS testing of cystic fibrosis in newborn screening samples. The contract term runs from May 1, 2026 through May 1, 2031, with an estimated total project cost of $375,000 over the five-year period.
The justification for sole source procurement is based on the exclusive availability of the xGen CFTR Amplicon reagents from IDT and the validated compatibility of this product with the Colorado Newborn Screening Program's existing workflows, instrumentation, and bioinformatics pipeline. The cost per sample for IDT xGen Amplicon at $47.59 was determined to be fair and reasonable when compared to alternative vendors, including IDT's Archer line at $155 per sample and Illumina's TruSight CFTR kit at $37.38 per sample, which did not meet the program's DNA input requirements or instrument compatibility needs. The evaluation process, which occurred between February 2024 and October 2025, assessed multiple vendors and products before selecting IDT based on cost efficiency, sample type criteria, and compatibility with the State Laboratory Genomics program's existing instruments and infrastructure.
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SOLE SOURCE JUSTIFICATION FORM:
This completed form is to be submitted to PCU via the Request website as the first step in the Sole Source Process.
Important! Consult the document “Sole Source Justification Guidance” for additional instructions.
TYPE OR CLEARLY PRINT ALL INFORMATION
Project Name: Colorado Newborn Screening CF NGS Testing Vendor name: Integrated DNA Technologies (IDT) Vendor Address: Integrated DNA Technologies, Inc.
1710 Commercial Park Coralville, Iowa 52241
USA
Select one: X Original ☐ Modification CORE Vendor ID:
PO or Contract Number (if this is a modification):
Describe the products and/or services to be procured and how they meet your needs. (This space is limited – provide a scope of work or specs as additional documentation).
IDT provides sequencing library preparation reagents for NGS testing of cystic fibrosis for use in the Colorado Newborn Screening Program. The CF NGS assay uses the xGen CFTR Amplicon kit, which is proprietary to IDT and not sold by other vendors.
List dates, agreement numbers and dollar amounts for any previously procured products or services from this vendor related to this project:
Term of agreement:
(If multi-year, indicate the full term up to 5 years)
| Start Date |
| 5/1/2026 |
| End Date |
| 5/1/2031 |
| If this is a modification, indicate the revised end date (if applicable). |
| Revised End Date |
| Estimated dollar amount - life of the project (up to 5 years): |
| Dollar |
amount 375,000
| If a modification, complete the following: |
| Amount |
Increased
Revised Total
If a modification, state the reason(s):
A. Criteria: Answer both 1 and 2.
| 1. There is only one Good or Service that will meet the needs of the State. |
| Yes X |
| No ☐ |
| 2. There is only one Vendor that can supply that Good or Service. |
| Yes X |
| No ☐ |
If “NO” to either 1 or 2, answer 3 and 4, below.
3. The compatibility of equipment, software, accessories, or replacement parts is the paramount consideration and the items are only available from one vendor.
a. Is this a software package or other IT system and the existing system now requires only ongoing maintenance and support?
| Yes ☐ |
| No ☐ |
| Yes ☐ |
| No ☐ |
| 4. A sole supplier’s item is needed for trial use or testing. |
| Yes ☐ |
| No ☐ |
If “NO” to 1-4, above, this is not a sole source.
STOP
A formal solicitation is required. Complete a Purchasing Determination Form.
Submit all required documents via the PCU Request Site.
B. Explain in terms of 1 through 4, above, the basis for your identifying this as a sole source? A sole source is justified in the instance that this is the only vendor - not what the program may determine to be the best vendor. Is this the only vendor? Explain (See form instructions)… The xGen Amplicon CFTR library preparation reagents are sold exclusively by IDT as they are the manufacturer of this product. These reagents were validated to perform this testing. Prior to validation a number of reagents were evaluated. Vendors with reagents at the time were Illumina and IDT. IDT had multiple reagents and methods. Illumina hand greater DNA input requirements and instrument requirements that we were unable to meet. NBS samples are blood spots that contain a low amount of DNA and vendors have a minimum quantity and quality of DNA as a testing requirement. xGen reagents from IDT met our sample testing requirements and were used to validate our method. In addition to DNA and sample requirements, instrumentation was a consideration. The NBS program has a MOU with the State Laboratory Genomics program to run our CF sequencing samples on their instruments. The xGen reagents met the Genomic program requirements for their instrumentation. Since Illumina’s sample and instrument requirements were not compatible with NBS workflows, IDT xGen assay is necessary for testing.
C. What makes this good or service unique to meeting your needs?
The CF NGS assay was validated for use with the IDT xGen Amplicon CFTR assay. Changing this assay would change the bench workflow process as each library preparation process is unique to each manufacturer. The bioinformatics pipeline currently used by the Colorado Newborn Screening Program has also been specifically configured for the coverage and indices used in the IDT xGen Amplicon CFTR assay. IDT xGen provides assay optimizations for the NBS blood samples.
| D. Is the Good or Service Proprietary (product or technology entirely owned by the individual/company and usually protected by trademark or copyright)? |
| Yes X |
| No ☐ |
E. What type of required, specific and exclusive experience, certifications, licenses etc. are possessed by this vendor that directly relate to the good or service to be procured?
IDT possesses the xGen Amplicon line and is the exclusive vendor for this product.
F. What research has the program conducted to justify this sole source?
This assay was validated from February 2024 to October 2025. During the validation process, other vendors and products were investigated for CF NGS testing. IDT xGen was selected based on cost per sample, sample type criteria, and instrumentation compatibility. Other tested and reviewed vendor methods didn’t meet our NBS sample criteria.
| G. Do you have an actual or potential conflict of interest in this purchase? (For example, is an individual from the Department or a family member affiliated with the vendor as an employee, board member, volunteer, etc.?) |
| Yes ☐ |
| No X |
If Yes: Please Explain. (This space is limited – please provide additional documentation if applicable.)
H. This Section is Required – You must answer “Yes” to at least one.
| 1. Did you compare prices/rates to established catalog prices or market prices? (If “Yes”, attach documentation) |
| Yes ☐ |
| No X |
| 2. Did you compare prices/rates to historical prices or rates for similar items or services procured in the past? (If “Yes”, attach documentation) |
| Yes X |
| No ☐ |
| 3. Did you conduct a cost/price analysis? (If “Yes”, attach documentation) |
| Yes X |
| No ☐ |
If No to #3 above:
| 4. Do you know if the cost is "fair and reasonable"? |
| Yes X |
| No ☐ |
Demonstrate how you determined fair and reasonable prices/rates: Attach additional pages if required.
Attached are quote for CFTR NGS library kits from two other vendors/lines:
IDT Archer Line: Each kit only covers 8 samples, making library reagents 155/sample.
Illumina TruSight CFTR Kit: Library preparation kit is 37.38 per sample, but can only be used on Dx instruments and using Dx reagents, which the state laboratory currently does not possess. Dried blood spot DNA extraction also does not meet the recommended sample requirements for this assay.
IDT xGen Amplicon: Cost is 47.59 per sample, which is reasonable based on above comparisons. Use of this assay also allows for use of instruments and reagents already purchased by the state for other assays, thereby reducing overall cost per sample over competitors.
Division: Laboratory Services Division Program: Colorado Newborn Screening Program Program Contact Name: Kendra (Jones) Croak Phone: 303-692-3675 Program Manager: Gregory Bonn --------------------------------------------------------------------------------------------------------------------------------------------------------------------- Procurement Use Only:------------------ Comments:
Approved: __________________________________________________________________________ Agency Procurement Director or Authorized Representative Signature Date Posted on VSS? Yes ☐ No ☐ If posted, original Intent to Sole Source VSS# __________________________________________
If not posted or modified, Approved CDPHE Request #: _______________________________________
Sole Source Justification 2 Version A2021
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