Sole Source Justification_Twist BioSciences.docx.pdf

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: Synthetic Viral Assay Controls and Custom Hyb Panels Vendor name: Twist BioSciences Vendor Address: 681 Gateway Blvd, South San Francisco, CA 94080 Select one: X Original ☐ Modification CORE Vendor ID: VC00000000427454 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).

Twist Biosciences has developed a proprietary semiconductor-based synthetic DNA and/or RNA manufacturing process featuring a high-throughput silicon platform that allows them to miniaturize the chemistry necessary for

DNA/RNA synthesis, thereby providing essential equivalency standards/controls that would need to be accessible to any laboratory performing quantitative RT-PCR, dPCR, NGS, or equivalent tests. Synthetic DNA/RNA controls created by Twist Biosciences are particularly useful for laboratories, such as CDPHE, that lack appropriate biosafety containment facilities for propagating a particular pathogenic virus or have difficulty gaining access to the organism in question from non-synthetic sources. In addition, non-synthetic sources lack the precision and high-fidelity of synthetic controls, which is a level of consistency that we need for sensitivity and specificity of dPCR and NGS assays. Twist have leveraged this same mechanism to create custom proprietary Hyb Cap panels.

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

GSP (Wastewater and Sequencing) Discretionary Purchases FY24 PO 2024*3250 $1,012.00 & FY25 PO 2025*5499

$25,066.00; Current quote request for controls and Hyb Panel is $891,380.

Term of agreement:

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

Start Date 5/15/2026 End Date 5/14/2030

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

$2.3M

If a modification, complete the following:

Amount Increased

Revised Total

If a modification, state the reason(s):

Original Justification:

Qty of 1 control is $3,090. Year to date requests/spending X 1= 125K + 225K for potential price increase and outbreak preparedness buffer over the life of the contract= $350K estimate.

Sole Source Justification 1 Version A2021

Modification Justification:

Current quote/quartzy requests for FY end to accommodate a special project deliverables is

$891,380. Additionally the original SS term was 1 year, so the contract is being updated to cover the remaining 4 years life of the project for an allowable total of 5 years. Beyond the special project needs, the dollar amount for routine testing (non-special project deliverables) should be $350K per/year.

Routine testing (350K x 4years) + Special Project (1 project X 891,380)= $2.3M (round to nearest whole)

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. Yes X 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.

Following a thorough online search, Twist Biosciences appears to be the only vendor on the market that is generating and selling high-fidelity, high-throughput, assay-ready, verified, sequence published, synthetic whole genome DNA/RNA viral controls.

Based on our lack of infrastructure dedicated to a viral culture workflow, propagating or procuring particular in vitro DNA/RNA pathogenic viruses for use as controls is not feasible. That is, synthetic is the only viable option currently for certain pathogens.

As additional element that makes synthetic whole genome viral controls an singular options, is the rapid availability of synthetic controls over non-synthetic controls in the event of an emergent threat, waiting for a viable non-synthetic option would deter rapid response.

Twist Hyb Cap Panel and the combination of targets as well as its customization strategies align with the guidance that Twist is the only vendor that meets the needs of the program.

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

Twist produces specific synthetic viral pathogen controls that are high-fidelity, assay-ready, whole genome, sequence published, lot traceable, and verified. These are necessary to meet the minimum standards of QA/QC metrics, as positive controls are needed to assess the efficacy/success of every single quantitative RT-PCR, dPCR, NGS, or equivalent test/assay performance. Additionally the Hyb Cap panel targets and the customizable probes and their

Sole Source Justification 2 Version A2021 reciprocal compatibility with our existing sequencing infrastructure and workflow makes Twist a singular option for testing.

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

D.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?

Twist Biosciences has developed a proprietary semiconductor-based synthetic DNA and/or RNA manufacturing process and all safety and containment infrastructure required to produce and sell assay-ready verified synthetic controls. As this is a procurement of goods and not service, there is no other specific or required considerations.

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

A thorough online search of synthetic virus control manufactures yielded only Twist BioSciences produced high-fidelity, high-throughput, assay-ready, verified, sequence published, synthetic whole genome DNA/RNA viral controls for specific pathogens.

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 X No

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"?

Although there is nothing on the market that is directly comparable to the Twist synthetic controls, based on the price for non-synthetic controls (~1043.00 per 1 Qty), the price for a guaranteed, high-fidelity yield for synthetic control seems justifiable and fair. The price is also reasonable in that we do not need to make infrastructure changes to facilitate onboarding and use of the controls, as Twist is assay ready.

Additionally, because these control and panels do not require additional processing and are ready to use there is no additional cost, labor or consumable associated with these reagents.

Yes X No

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

Sole Source Justification 3 Version A2021

Division: Laboratory Services Division

Program: Genomic Surveillance Program, Sequencing and Wastewater Unit

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 ☐ No ☐ If posted, original Intent to Sole Source VSS# __________________________________________

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

Sole Source Justification 4 Version A2021

SOLE SOURCE JUSTIFICATION FORM: