Sources Sought for the purchase of Qiagen EZ2 connect MDx IVD Systems

The Centers for Disease Control and Prevention (CDC) is issuing this sources sought synopsis as a means of conducting market research to identify parties having an interest in and the resources to support this requirement for purchase of Qiagen EZ2 Connect MDx IVD extraction system for extracting nucleic acid from clinical specimens.

The Qiagen EZ2 Connect MDx is an FDA-approved (IVD-cleared) extraction platform that will be used in conjunction with the CDC FDA-approved and FDA-authorized in vitro diagnostics for the detection of Influenza and SARS-CoV-2 viruses from clinical samples. The CDC needs to evaluate the performance of our FDA-cleared and FDA-approved in vitro diagnostic assays for influenza and SARS-CoV-2 on samples extracted with a Qiagen EZ2 instrument.

The Qiagen EZ2 Connect MDx is a fully automated clinical nucleic acid extraction system with a pre-filled cartridge-based system with scalable extraction of 1 to 24 samples. Qiagen will manufacture supplies and provide the EZ2 Connect MDX extraction system, maintenance services, Installation, and training. The result of this market research will contribute to determining the method of procurement.

The applicable North American Industry Classification System (NAICS) code assigned to this procurement is 325413 In-Vitro Diagnostic Substance Manufacturing. There is no solicitation at this time. This request for capability information does not constitute a request for proposals or quotes; submission of any information in response to this market survey is purely voluntary; the government assumes no financial responsibility for any costs incurred.

If your organization has the potential capacity to provide these supplies, please provide the following information: 1) organization name, address, email address, website address, telephone number, and size and type of ownership for the organization; and 2) product information and estimated price for products and delivery scheme as outlined in attachment 1. This does not have to be exact; it is for planning purposes only.

The government will evaluate market information to ascertain potential market availability of the potential of these products being sold by more than one contractor. There are compatibility issues; however, the CDC encourages competition and is seeking a solution, if possible, that could be provided by multiple vendors.

Based on the responses to this sources sought notice/market research, this requirement may be set-aside for small businesses or procured through full and open competition, or procured via a sole source procurement. Telephone inquiries will not be accepted or acknowledged, and no feedback or evaluations will be provided to companies regarding their submissions.

Additional Market Research Questions: Does your firm offer the products listed in below? Product Number /Contract Line Item Description/ Quantity 9003230/EZ2 Connect MDx/3 9245572/ EZ2 Connect, Installation and Training/3 9245575/EZ2 Connect, IQOQ Service/3 9245929/EZ2 Connect MDx, Full Agreement/3 Can you firm provide the products in the needed timeframe of 60 days after receipt of order (ARO)? Are the products offered by your firm made in America or made in other countries? If made outside of the United States, please list the country in which each component is made.

Submission Instructions: Interested parties who consider themselves qualified to provide the above-listed software are invited to submit a response to this Sources Sought Notice by 4:00 PM CDT on August 09, 2024. All responses under this Sources Sought Notice must be emailed to the Contract Specialist, Kahala McCaskey, at zch2@cdc.gov. If you have any questions concerning this opportunity, please contact the Contract Specialist.