Inactive

PRE-SOLICITATION NOTICE **NOTICE OF INTENT NOI-NIAID-2170361 NAICS – 325413, In-Vitro Diagnostic Substance Mfg This is a Notice of Intent, not a request for proposal. The National Institute of Allergy... PRE-SOLICITATION NOTICE **NOTICE OF INTENT NOI-NIAID-2170361 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 27 (IgG) Kit (25 PL), catalog # K15606U-4 (QTY 12 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 300 MSD 96-well SARS CoV2 multiplex plates. The objective is to supply the plates for the VIP to perform the assay testing in support of SARS CoV2 therapeutic antibody isolation and development projects as well as correlates of protection testing. Description of the supplies/services to be purchased: MULTI-SPOT® 96 10-Spot Custom SARS-CoV2 Custom Panel (125 plates across 2 panels) 300 x panel plates of Key CoV-2 spike variants including WT, beta, delta, BA.1, BA.2, BA.5 Provide all accompanying reagents, including but not limited to: SULFO TAG Anti Human lgG Antibody Calibrator/Normalization Reagent MSD Blocker A x Diluent 100 MSD Gold Read Buffer B Wash buffer 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, B.1.351, B.1.617). Spike proteins are 'printed' or 'spotted' in a single well of an 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. 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-2170361) to Dana Monroe at dana.monroe@nih.gov, by 5:00pm eastern daylight savings time Sunday, April 16, 2023. 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.