A13 - 2022 07 30 - 2022-66884 - SSJ (redacted).pdf

Rev. 5/14/19

D. Justification:

1. The justification for this non-competitive action is:

☒ In accordance with FAR 13.106-1(b)(1), “only one source [is] reasonably available” which states that, “For purchases not exceeding the simplified acquisition threshold. (i) Contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name or industrial mobilization). (ii) Where a single source is identified to provide a portion of a purchase because that portion of the purchase specifies a particular brand-name item, the documentation in paragraph (b)(1)(i) of this section only applies to the portion of the purchase requiring brand-name item. The documentation should state it is covering only the portion of the acquisition which is brand- name.”

☐ Urgency ☐ Exclusive licensing agreements/Proprietary data ☐ Brand name required ☐ Industrial mobilization ☒ Other (e.g., compatibility, space issues, continuity, etc.)

☐ In accordance with FAR 8.405-6 “Limiting Sources” which states that, “the only circumstances that may justify the action are – (A) An urgent and compelling need exists, and following the procedures would result in unacceptable delays; (B) Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized; or (C) In the interest of economy and efficiency, the new work is a logical follow-up to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original BPA must not have been previously issued under sole-source or limited-sources procedures.”

☐ Urgency ☐ Only One Source ☐ Logical Follow Up ☐ Brand name required

2. Other facts supporting sole source procurement:

a. What can this product/service do that other products/services cannot do?

The purpose of this service order is to construct and optimize a multi-pathogen, digital PCR-compatible assay panel from existing real time PCR assays in use at the CDC and elsewhere, for use by CDC, CDC public health partners, and environmental laboratories to interrogate wastewater for multiple pathogen and AR targets in a standardized format. This service will involve constructing a multiplexed, multi-pathogen, digital PCR-based assay panel from approximately 30 existing PCR assays or molecular targets, as defined by the CDC

. To maximize compatibility with existing instrumentation at partner laboratories and to simplify data analysis and reporting to the CDC , the panel will be developed for operation on the Bio-Rad QX series droplet digital PCR platform and the Qiagen Qiacuity series digital PCR platform, and will be limited to fluorescent dyes and corresponding instrument channels that are common to both instruments. It was determined that the GT Molecular company is the only molecular assay development vendor that is qualified and capable of accomplishing this service simultaneously for both digital PCR platforms. GT Molecular is the only company uniquely suited for this service because they currently employ both the Qiagen and the BioRad branded digital PCR platforms in-house, and thus, have direct, relevant experience in assay development and testing for both instruments.

In addition, GT Molecular is not restricted to a single brand molecular detection platform because they do not manufacture the PCR instruments, and have no interest in the success of one platform over another.

b. What other products/services were considered and why did they not meet the need?

Multiple large and small vendors were considered that did not meet the needs for this service. Three vendors, IDT, Luminex, and BioFire Technologies, did not offer the custom assay panel service being requested. The BioGX company was able to offer custom real-time PCR assay design services, but they did not have digital PCR instrumentation in their facilities and, thus, did not offer digital PCR assay design and validation. Both BioRad Laboratories and Qiagen offered custom digital PCR assay design services for their respective branded instruments, but they were unable to offer assay optimization, design and validation for digital PCR platforms from other manufacturers, and thus were not able to create and test assays for more than one instrument platform, as is required for the service being requested. GT Molecular was the only vendor capable and qualified to simultaneously develop digital PCR assays per criteria for the 2 different instrument platforms from Qiagen and BioRad.

3. Program Office efforts to seek potential offerors:

The program office performed internet and catalog searches for small and large vendors who offer molecular assays and/or molecular assay design and construction services that meet specifications. All potential offerors initially identified were directly contacted by email and/or phone for market research purposes and additional phone meetings were arranged with potential offerors that still met the program service criteria after the initial communication. The program office gathered directly relevant information during these multiple discussions with vendors regarding their digital PCR assay design capacity and capabilities.

E. Program Office Certification:

I have reviewed this sole source justification and certify the justification is true and accurate to the best of my knowledge and adequate to support other than full and open competition.

Center/Institute/Office COR/Program Official Name/Title:

Center/Institute/Office COR/Program Official Signature:

Certification Date:

F. Contracting Office Certification:

I have fully relied on the information provided herein and hereby certify that this justification is accurate and complete to the best of my knowledge and belief:

Contracting Officer Name: Lee Catherine Kennedy

Contracting Officer Signature:

Certification Date: 30 July 2022