Sole Source Justification_IDT MOD_AEBR_SM_updated (1).pdf

Sole Source Justification 1 Version A2021

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: Integrated DNA Technologies (IDT) Reagents Contract for WW + SEQ Units Vendor name: Integrated DNA Technologies, Inc. henceforth IDT Vendor Address: 1710 Commercial Park, Coralville, Iowa 52241, USA Select one: ☐Original X 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 is the sole source for custom or pre-designed, pooled, paneled multi- or single- plexed based oligonucleotide manufacturing providing the most advanced synthesis, modification, purification, and quality control capabilities available for their proprietary primer and probe products.

This project pertains specifically to reagent procurement (primers, probes, panels and kits) that amounts to over the discretionary limit of spending each year, covering the necessary expenditure for both the Wastewater (WW) and Sequencing (SEQ) Genomic Surveillance Program units.

List dates, agreement numbers and dollar amounts for any previously procured products or services from this vendor related to this project:

Prior to this SS and its modification, no previous contracts for IDT exist for the WW and SEQ units; all spending has been emergency procurement or discretionary. In 2025/2026 FY to date these two units spent $216,564.91. Program has identified the need for a surge panel that is estimated to be $180k alone, which is in addition to the procurement of our routine clinical and surveillance workflow reagents.

For these reasons it was determined that a contract would be appropriate to continue the uninterrupted procurement of necessary testing reagent goods from IDT.

Term of agreement:

(If multi-year, indicate the full term up to 5 years)

Start Date 8/1/2024 End Date 8/1/2029

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

650,000.00

If a modification, complete the following:

Amount Increased

1,050,000.00 Revised Total

1,700,000.00

If a modification, state the reason(s):

Program has identified the need to procure additional supplies from this vendor in response to a new deliverable and its increase in testing capacity. The new dollar amount is estimated based off of

FY 2025/2026 expenditure x3 years life of remaining contract plus 60% buffer for price increases, outbreak responses, or unknowns.

Sole Source Justification 2 Version A2021

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 X

Yes ☐ No X

4. A sole supplier’s item is needed for trial use or testing. 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).

To my knowledge and per the CDCs determination of IDTs sole source status for Primers/Probes, Panels and kits, as well as how deeply integrated into the current workflows, IDTs products are necessary for meeting the states testing needs (specificity and sensitivity). That is, IDT is the only vendor that can provide oligonucleotides that meet the states needs for both current and future testing protocols including those protocols maintained internally as well as those adopted from external stakeholders like CDC. All viral testing workflows for research, surveillance, and diagnostic purposes all currently utilize IDT products.

C. What makes this good or service unique to meeting your needs?

Imagine that a sample that has been submitted for testing either for research, surveillance, and diagnostic purposes. That specimen tube with its contents is like a bookstore and all of components in that tube (proteins, human cells, pathogens (viral or bacterial), non-harmful bacteria (called fauna and flora of the body) ect.) are the “books” in the “book store”. Now imagine that you know you are looking for a hand written message inside a first edition of a specific book, in this case you know the message and the title, but you have to find it mixed in with all the other books and notes. It would be much easier to find and study the book of interest if you had a “control + find” function to physically pull that book out of the mix and confirm that the quote lines up, and with IDT products you do have that capability. That is, primers/probes when added to a specimen “pull out” and allow the amplification and subsequent detection of specific targets within a mix of other components that are not of interest for the given testing. The primers are so specific and sensitive that they can tell you the presence of the target or the absence of it, if nothing at all is detected when the primer/probe added to the sample. Each pathogen has to have its own primer/probe that is specific/sensitive to its code, which is why customization is crucial to testing success. This is also why IDT product is used in nearly every single workflow in Wastewater and Sequencing. In short, if you have ever wondered “but how do you know I have COVID and not Flu or RSV, or Rhinovirus (all which have the same symptoms)?”—the

Yes X

Sole Source Justification 3 Version A2021 answer is primers and probes and the kits that work with them to detect targets of interest with sensitivity and specificity. Notably, Probes are patented and while probes are available through ThermoFisher, IDT and Thermo hold different patents on their proprietary probes and therefore the procurement of certain probes must be done through the vendor that owns them.

D. Is the Good or Service Proprietary (product or technology entirely owned by the individual/company and usually protected by trademark or copyright)?

The product including the kits and certain probes as well as their synthesis and QC process are proprietary technology that has been validated and is owned and distributed solely by IDT.

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 is currently used by CDC to produce primers, probes, kits and panels required for testing. All of which must be validated and QC checked/certified both externally (by the manufacturer) and internally (by lab staff on receipt) prior to use for IVD or LDT testing. Since IDT product is used currently internally (IDT primers and probes are a part of every WW + Seq workflow currently in use and planned) as well as by external stakeholder labs (CDC, FDA, other public health partners), the validation/verification and subsequent results for research, surveillance, and diagnostic assays across labs is comparable and the process to onboard and maintain certified testing is minimal.

F. What research has the program conducted to justify this sole source?

It has been determined to be a Sole Source by CDC for primer, probes, and panels, as posted via public notice to GovTribe and Sam.Gov. Other federal entities have also declared IDT as sole source for primer, probes, and panels, including the Dept of the Navy and the Armed Forces Dept of Pathology. Additionally, IDT has proprietary rights to certain probes and kits including xGen Hyb Cap, required for IVD testing.

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 ☐ No X

If No to #3 above:

4. Do you know if the cost is "fair and reasonable"?

There is not really any offering on the market that is directly comparable to the IDT catalog, their prices over the last three years for routinely procured primers, probes and kits have remained fairly stable, however our demand for the product has

Yes X No ☐

Sole Source Justification 4 Version A2021 increased, which has in turn increased the annual expenditure with IDT. Perhaps the most indicative comparison as it pertains to “fair” is that Illumina offers a version of a multi-target panel with 60 targets, and only 8,000 probes (which is procured by **Illumina from IDT and ironically repackaged) is $27,000.00, while a single target panel for the entire list of Influenza Subtype (18 H types, 11 N types, and 131 unique subtype combinations) with 96,000 probes custom designed by IDT for CDPHE influenza testing was quoted as $37,000.00. **Notably, Illumina only sells their panels made by IDT specifically for WGS testing, they do NOT offer the full range of IDT products or any customizable options outside of their catalog offering. They are not considered an IDT distributor

Demonstrate how you determined fair and reasonable prices/rates: Attach additional pages if required.

Division: DCPHR (Lab Services)

Program: WW and Seq Units, GSP

Program Contact Name: Alexandria Rossheim

Phone: 408-529-7406

Program Manager: Shannon Matzinger

-------------------------- Procurement Use Only:------------------

Comments:

Approved: __________________________________________________________________________ Agency Procurement Director or Authorized Representative Signature Date

Posted on VSS? Yes ☐ N o ☐ If posted, original Intent to Sole Source VSS# __________________________________________

If not posted or modified, Approved CDPHE Request #: _______________________________________

Shannon Matzinger Digitally signed by Shannon Matzinger Date: 2026.03.27 11:21:52 -06'00'

Alexandria Rossheim Digitally signed by Alexandria Rossheim Date: 2026.03.27 10:56:27 -06'00'