Notice of Intent to Award to Sole Source - QuantStudio 5 Dx Real-Time PCR System,5 Dx Real-Time PCR System

The Centers for Disease Control and Prevention (CDC) intends to award a sole source, firm fixed price contract to BIOANALYTICAL INSTRUMENTS INC. 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 13.106-1(b) (SAP) and 41 U.S.C. 3304(a)(1). The North American Industry Classification System code for this procurement is 423450 - Medical, Dental, and Hospital Equipment and Supplies Merchant Wholesalers.

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 proposals; however, all responses received within three (3) 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 normally be considered solely for the purpose of determining whether to conduct a competitive procurement. Any quotation/response should be emailed to the contract specialist Ruben Reyes at qmz3@cdc.gov by 12:00PM, September 6, 2024. The QuantStudio 5 Dx (QS5DX) Real Time PCR Cycler is the new generation of instruments from Thermo Fisher for molecular in vitro diagnostics applications. This new instrument replaces the ABI 7500 and will also replace the QuantStudio Dx (QSDX).

Both of these instruments will be discontinued by the company in the next 5 years. The CDC DENV 1-4 RT PCR test for the diagnosis of dengue virus infection is currently the only FDA-approved test for the diagnosis of dengue infection and this test has only been validated in both instruments that soon will be out of the market. Our laboratory is currently validating the CDC Dengue PCR test in the new QS5DX instrument for submission to the FDA for the benefit of domestic and international public health laboratories.

The Thermo QS5DX will soon be the only instrument approved by the FDA for performance of the CDC dengue PCR test. Bioanalytical Instruments, Inc. is the exclusive local supplier of Thermo Fisher instruments and the only authorized service provider for Thermo Fisher equipment in Puerto Rico. Other products/services were not considered to ensure reproducibility of results and to comply with FDA regulations. The quote provided by the vendor includes a trade-in offer to substitute two older QSDX instruments currently in use at the DB Lab by two of the new updated QS5DX.