6515--FY25 IDIQ GENDX Reagent

This is a Notice of Intent published in accordance with Federal Acquisition Regulation (FAR) 5.101(a)(1) requiring the dissemination of information regarding proposed contract actions. This Notice of Intent is for a proposed award of a sole source firm fixed price contract to the following contractor in support of Histocompatibility and Immunogenetics Laboratory in support of Iowa City VA Health Care System, 601 Highway 6 West, Iowa City, IA 52246-2209:

GENDX PRODUCTS INC

SAM UEI: JFZKARM2NL52

5521 N Cumberland AVE

STE 1116

Chicago, Illinois

60656-1479, United States

This is done under authority of 41 U.S.C. 3304(a)(1), as implemented by FAR 6.302-1: Only one source and no other supplies or services will satisfy agency requirements.

This is not a request for competitive quotes.

Market research revealed that GENDX PRODUCTS INC GenDx NGS Kits have been validated to be compatible with current inhouse equipment that is currently being utilized by Iowa City VA Health Care System.

Required on contract are NGS reagent kits used to perform identification of human leukocyte antigen alleles through amplification of A, B, C, DPA1, DPB1, DQA1, DQB1, DRB1, DRB3/4/5. The GENDX PRODUCTS INC GenDx NGS Kits are found to be compatible with the current inhouse equipment used in the HLA lab. After selection of the appropriate assays and reagents the testing performed was validated and utilized for transplant genotyping and aids in selection of organs. To switch to a new vendor of reagents requires a long validation process, approval by the ASHI Accreditation Review Board to change the protocol and ensure the validation was successful. Due to the complexity of this process the is only able to utilize GenDx NGS Kits.

The North American Industry Classification System (NAICS) code for this service is 325411 (Medicinal and Botanical Manufacturing) and the Product Service Code (PSC) is 6515 (Medical and Surgical Instruments, Equipment, and Supplies).

While this synopsis does not constitute a solicitation, interested vendors may identify their interest and capability to satisfy the requirement, including documentation that such contractor could provide this service as an authorized reseller, authorized dealer or third party.

All responsible sources may submit a capability statement, which shall be considered by the agency by e-mailing such statement and supporting documentation to Christi Melendez, Contracting Specialist, at Christi.Melendez@va.gov. No phone calls please. Please indicate Response to GENDX Reagents in subject line of e-mail.

Such documentation will be reviewed solely for the purpose of determining whether or not to conduct the procurement on a competitive basis. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government under authorities cited above.