Intent to Sole Source Bio-Rad OPUS DX Instruments

The Center for Disease Control and Prevention (CDC), National Center for Immunization and Respiratory Diseases Influenza Division (NCIRD/ID), intends to award a sole source purchase order in accordance with FAR 13.106-1(b)(1), soliciting from a single source, to Bio-Rad Laboratories Inc., 4000 Alfred Nobel Dr., Hecules, California 94547, for Bio-Rad OPUS DX instruments to detect influenza and SARS-CoV-2 from clinical specimens. These instruments are proprietary to Bio-Rad and are FDA-approved in vitro diagnostic (IVD) and reverese-transcriptase real-time polymerase chain reaction (rRT-PCR) instruments. The NAICS code for this procurement is 334513, Instruments and Related Products Manufacturing for Measuring, Displaying, and Controlling Industrial Process Variables.

The purpose of this acquisition is to purchase Bio-Rad OPUS Dx instruments to evaluate the performance of our FDA-cleared and FDA-approved in vitro diagnostic assays for influenza and SARS-CoV-2 on this instrument. The Bio-Rad OPUS Dx can multiplex up to 5 targets per well. Moreover, it uses a distinct method for collecting the data in each well that is unique to BioRad instruments. BioRad is the only company that produces the OPUS Dx 96-well rRT-PCR instrument. Consequently, the CDC,NCIRS/ID is considering Bio-Rad Laboratories Inc. for a sole-source award to fulfill this requirement.

As a result of this notice, no competitive solicitation will be posted on SAM.gov. The government will issue only one solicitation to Bio-Rad Laboratories Inc. However, firms that believe they can meet this requirement are encouraged to identify themselves and give written notice by providing a capability statement to the contract specialist, Dawnnia Daley, at xwf5@cdc.gov by August 7, 2024, at 5:00 p.m. EDT. The contract specialist will not respond to verbal requests. All requests must be in writing.

A determination by the government not to take this proposed action will be based on responses to this notice and is solely within the discretion of the contracting officer. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. Inquiries shall reference the solicitation number, 75D301-24-Q-78076, on the subject line and be sent to Dawnnia Daley by email at xwf5@cdc.gov.