V-PLEX SARS-CoV-2 Panel 26 (IgG) Kit (25 PL)

PRE-SOLICITATION NOTICE

NOI-NIAID-2126505

NAICS – 325414, Biological Product 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 Panel 26 (IgG) Kit (25 PL), catalog # K15593U-4 (QTY 4 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 in the process of developing an assay for detection of binding antibodies to subdomains of the spike such as RBD, NTD, S1 and S2, which offers high throughput measurement of immune responses elicited by infections.

As the threat of COVID-19 continues in the international community with new variants emerging every week, the need for a safe and efficacious monoclonal antibody therapy at an accelerated timeline is a health care priority. To assist in this effort, the VRC-VIP will use the electrochemiluminescent (ECL) assay format which they have recently developed for a SARS CoV-2 specific assay for the detection of specific antibodies directed towards SARS CoV-2 S-2P and RBD (or other stabilized version of this same protein), variants and subvariants (B.1.1.529, AY.4, B.1.1.7, B.1.351, P.1). RBD proteins are 'printed' or 'spotted' in a single well of a MSD 96-well microtiter plate. The VRC-VIP identified the ECL assay as the most reliable and sensitive assay system over the last 10 years, that offers high dynamic range in the detection of specific serum antibodies generate towards a variety of viral proteins. The platform offers extremely high throughput for the simultaneous measurement of antibodies to their epitopes. Since the multi-plex assays used for Ph1 and Ph3 testing is on the MSD platform, it is very logical to also develop the 10-plex assays on the same platform for ease of testing and familiarity of the technology and utilization of the current instruments in the lab. x MSD are the sole owners of the intellectual property of the ECL assay designed in collaboration with VIP specifically for VIP endpoint testing for COVID-19 Phase 1,3 trials and screening of SARS CoV-2 mAbs.

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-2126505) to Dana Monroe at dana.monroe@nih.gov, by 5:00pm eastern daylight savings time Sunday, May 8, 2022.  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.