Digital PCR Assay Panel Optimization, Design, & Construction Services

The Centers for Disease Control and Prevention (CDC) intends to award a fixed-price contract on a sole source basis to GT Molecular, LLC, Fort Collins, CO for Digital PCR assay panel optimization, design, and construction services for the Qiagen Qiacuity series and BioRad QX series digital PCR instruments. This is the only known Vendor who is able to construct and optimize a multi-pathogen, digital PCR-compatible assay panel from existing real time PCR assays in use by the Government and elsewhere, for use by the Government, its 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 Government. To maximize compatibility with existing instrumentation at partner laboratories and to simplify data analysis and reporting to the Government, 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. This is the only known Vendor who is the only molecular assay development Vendor that is qualified and capable of accomplishing this service simultaneously for both digital PCR platforms. This Vendor is the only organization suited for these services 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, this Vendor 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, which benefits the Government. The North American Industry Classification System Code (NAICS) for this requirement is 541715 with a size standard of 1,000 employees. This contract action is for supplies or services for which the Government intends to solicit and negotiate with only one source under the authority of FAR Part FAR 13.106–1 (b) and 10 U.S.C. 2304 (c) (1). Interested persons may identify their interest and capability to respond to the requirement or submit proposals.

This Notice of Intent is not a request for competitive quotations; however, all quotations/responses received within six (6) calendar days of the issuance of this notice will be considered by the Government. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. Any quotation/response should be emailed to the Contract Specialist, Lee Catherine Kennedy, at vhg0@cdc.gov by 2:00pm ET, Friday, 5 October 2022.