V-PLEX SARS-CoV-2 key variant spike panel 1 (IgG) Kit (25 PL), catalog # K15651U-4

NOI-NIAID-24-2220908 NAICS – 325413, In-Vitro Diagnostic Substance Mfg This is a Notice of Intent, not a request for proposal.

The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) intends to negotiate on an other than full and open competition basis with Meso Scale Discovery, a division of Meso Scale Diagnostics, LLC of Rockville, MT to procure V-PLEX SARS-CoV-2 key variant spike panel 1 (IgG) Kit (25 PL), catalog # K15651U-4 (QTY 2 EA) to be used by the NIH Vaccine Research Center (VRC) Vaccine Immunology Program (VIP) to perform assay testing in support of a SARS CoV2 therapeutic antibody isolation and development project.

The Vaccine Immunology Program (VIP) aids the Vaccine Research Center (VRC) by supporting the development of monoclonal antibodies and vaccines for infectious diseases such as HIV, Influenza, Ebola, and more recently SARS-CoV-2 Coronavirus. Support is through the state-of-the-art laboratory performing Phase 1 and Phase 3 clinical end point testing to inform further study designs, research questions and vaccine modification and design.

As part of a broader strategy to accelerate the development of monoclonal antibodies as therapy for targeting SARS CoV-2 spike and its newly emerging variants, VIP has identified the electrochemiluminescent (ECL) assay format as the most reliable and sensitive assay system that offers high dynamic range in the detection of antibodies isolated specific to SARS-CoV-2 spike (S2P).

Specifically, the VIP is developing assays for detection of binding antibodies to spike variants, which offers high throughput measurement of immune responses elicited by infections and vaccinations. The purpose of the procurement is for the vendor to provide QTY 2 EA V-PLEX SARS-CoV-2 Key Variant Spike Panel 1 (IgG) kit 25PL, product # K15651U-4, to retain continuity in COVID research already underway. The statutory authority for this sole source requirement is 41 U.S.C.

1901 (a) (1) as implemented by FAR 13.106-1 only one responsible source and no other supply of service will satisfy agency requirements. THIS IS NOT A REQUEST FOR PROPOSAL.

All responsible sources that could provide comparable services may submit a capability statement that will be considered by email (subject line to reference NOI-NIAID-24-2220908) to Dana Monroe at dana.monroe@nih.gov, by 5:00pm eastern daylight savings time Monday, April 29, 2024. All responses received by the closing date of this synopsis will be considered by the Government. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government.